FrailtyISHANCT06270979
Intrinsic Capacity and Functional Ability Monitoring With an Integrated Data Eco-System for Healthy Ageing.
An observational study of Frailty, run by Prof. Ivan Bautmans.
Trial summary
In this study, 120 older adults (aged 65 years or older) either patients undergoing rehabilitation or older nursing home residents will be provided with an Eforto® device and the eco-System for Healthy Ageing (ISHA) mobile application to self-monitor intrinsic capacity for 4 months (if needed with assistance by an… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- ISHA
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients undergoing rehabilitation and nursing home residents, all aged 65 years or older.
Who may be able to join
- Aged 65 years or older.
- Patients living independently at home and undergoing rehabilitation, or older persons living in the residential care community (in a nursing home or in assisted housing).
- Being able to operate the basic functions of a smartphone (if needed with assistance by an informal caregiver): using a smartphone at least for calls, and minimum 1 other application.
- Understanding Dutch.
- Exclusion Criteria: Being unable to participate in the assessments due to:
- Being unable to perform the physical (self)tests (e.g., unable to stand up or walk);
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- Being unable to understand the test instructions;
- Functional disability of the dominant upper extremity (paresis/paralysis, tremor or recent surgery);
- Patients undergoing neurological rehabilitation.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility and Usability of Intrinsic Capacity Monitoring With an Integrated Data Eco-System for Healthy Ageing, and Its Association With Health Outcomes in Older Patients Undergoing Rehabilitation and in Older Nursing Home Residents.
In this study, 120 older adults (aged 65 years or older) either patients undergoing rehabilitation or older nursing home residents will be provided with an Eforto® device and the eco-System for Healthy Ageing (ISHA) mobile application to self-monitor intrinsic capacity for 4 months (if needed with assistance by an (in)formal caregiver). Preferably, the participants will use their own smartphone because mitigating smartphone-use-related issues.
The aims of the study are:
- to evaluate the usability and feasibility of self-monitoring intrinsic capacity by using the ISHA system in rehabilitation and nursing home settings.
- to investigate if changes and variability in intrinsic capacity as measured with ISHA are related to changes in functional ability and quality of life.
- to explore individual trajectories of intrinsic capacity with the ISHA system.
Read the detailed description
Investigational device:
The ISHA digital eco-system (class IIa investigational medical device).
ISHA consists of 3 components:
- An Eforto® device: a handheld grip work (GW) hardware device, composed of a rubber bulb, to be compressed by the user and plastic enclosure that holds the electronic components such as a pressure sensor, battery, and connectivity. A mouthpiece can be attached for respiratory capacity monitoring. The Eforto® system was developed based on approximatively 20 years of scientific research on handgrip muscle fatigability performed by the Frailty in Ageing research department (see https://fria.research.vub.be/) and in collaboration with top-level international partners. The Eforto® system allows self-assessment of muscle fatigability and self-perceived fatigue in older adults and functions as a monitoring tool for intrinsic capacity. It is a small device, easy to use, and suitable for home measurements as well as hospital settings. When used correctly, the measurements cause no discomfort and can be performed repeatedly. The Eforto® device connects to a smartphone application that provides verbal test instructions to the participant. The app will guide the participant during the test and automatically provide motivational cues via audio. The test results are aggregated and stored in a cloud platform where the researcher can manage subjects, access the test data and export it for further analysis.
- Mobile application that ensures connectivity and collection of data from the Eforto® device and by which multiple guided tests for the locomotor (maximal grip strength, respiratory muscle strength, muscle fatigue resistance test \& self-perceived fatigue questionnaire), sensory (hearing test (signal to noise technology) \& vision test (rotating E test), cognitive (orientation test, object naming from description, animal naming \& 10-words immediate and delayed recall), and psychological (resilience questionnaire) domains of intrinsic capacity can be completed. The app allows offline data collection and to synchronize with the third component, the remote monitoring platform. It serves as an interactive guidance and can be used by the subject/patient at home or assisted by a (formal or informal) caregiver.
- The remote monitoring platform serves mainly as a dashboard for monitoring the older end-users. Its main purpose is to centralize and monitor the collected data.
Procedures:
The study will be approved by the institutional review board's and all participants will sign informed consent.
After informed consent is given, the eligibility assessment and T0 (baseline) measurements will take place. These measurements will be re-assessed after 2 months and 4 months.
During this test moments the participant will be asked to perform the ISHA-tests (intrinsic domains: vitality, locomotor, sensory, cognitive and psychological). Other tests that will be assessed are: anthropometry (body weight \& height and waist \& hip circumference), health status (medical history, Center for Epidemiologic Studies Depression scale (CES-D), Mini Mental State Examination (MMSE), fall incidents, hospital admissions, Mini Nutritional Assessment (MNA) and orthostatic test), Frailty (Fried Criteria), functional dependency tests (Montreal Cognitive Assessment (MOCA), basic activity of daily living (ADL) (Katz), instrumental ADL (Lawton) and Short Physical Performance Test (SPPB)), questionnaires (Sarcopenia Quality of life questionnaire (SarQol), Eq-5D-5L, International Physical Activity Questionnaire (IPAQ), health-economic questionnaire and general health questions) and technical problem/ usability, feasibility and expectations questionnaires. In the context of eligible check, the smartphone experiences and personal data e.g. sex, birth day date, living situation will be asked.
After an individual information session with training on the ISHA test battery and instructions for ISHA use in self-test mode, the participant will be instructed to perform the ISHA measurements for 4 months at their home (if needed with assistance by an (in)formal caregiver). Preferentially, the healthcare professional (occupational therapist, physical therapist, study nurse) will install the ISHA application on the smartphone of the participant. If during the individual information session, the participant is unable to correctly operate the ISHA tool, the healthcare professional will explore together with the participant whether a (informal or formal) caregiver could aid, and eventually the participant will be re-invited together with his/her informal caregiver for another information/training session. If correct use of the ISHA system by the participant and/or assistance by a caregiver is impossible, the participant will be excluded for further participation in the study.
The self-test measurements will be continued for 4 months or until withdrawal of the participant. The self-tests will be performed:
- weekly on 2 consecutive days per week for vitality capacity;
- once every two weeks for locomotor capacity, and
- once every month for sensory, cognitive, and psychological capacity.
The application will give a reminder to the participant every time he/she needs to do the ISHA measurements.
During the study, participants will be contacted every month by a researcher to register any changes in health situation as well as technical issues encountered during the self-testing.
- Conditions
- Frailty
- Being tested
- ISHA
- Keywords
- Self-monitoring, Intrinsic capacity, Prevention
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISHADevice
Participants will be provided with an Eforto® device and ISHA mobile application to self-monitor intrinsic capacity for 4 months (if needed with assistance by an (in)formal caregiver).
| Study group | Role | What they receive |
|---|---|---|
| Leiehome vzw | Participant recruitment entails including persons aged 65 years or older living in an assisted housing or a nursing home. Receives: Device: ISHA | |
| University Hospital Antwerp/University of Antwerp | Participant recruitment entails including persons aged 65 years or older undergoing rehabilitation at University Hospital Antwerp. Receives: Device: ISHA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential technical problems of the ISHA system
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 1
Potential technical problems of the ISHA system
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 2
Potential technical problems of the ISHA system
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 3
Potential technical problems of the ISHA system
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 4
Potential technical problems of the ISHA system
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 5
Potential technical problems of the ISHA system
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 6
Potential technical problems of the ISHA system
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 7
Potential technical problems of the ISHA system
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 8
Potential technical problems of the ISHA system
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 9
Potential technical problems of the ISHA system
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 10
Potential technical problems of the ISHA system
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 11
Potential technical problems of the ISHA system
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 12
Potential technical problems of the ISHA system
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 13
Potential technical problems of the ISHA system
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 14
Potential technical problems of the ISHA system
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 15
Potential technical problems of the ISHA system
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 16
Experiences with ISHA (usability, feasibility and acceptability outcome)
An self-reported questionnaire (19 questions) based on the System Usability Scale (SUS). Options for answer: 1-5. 1 is 'Strongly disagree', 5 is 'Strongly agree'.
Measured: End of the study (week 16)
Secondary outcomes (48)
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB
Mobility is assessed by the SPPB, including gait speed(m/s) via the 4-meter test(s).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: Baseline
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB
Mobility is assessed by the SPPB, including gait speed(m/s) via the 4-meter test(s).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 2 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB
Mobility is assessed by the SPPB, including gait speed(m/s) via the 4-meter test(s).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 4 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB
Mobility is assessed by the SPPB, including gait speed(m/s) via the 4-meter test(s).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: Baseline
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB
Mobility is assessed by the SPPB, including gait speed(m/s) via the 4-meter test(s).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 2 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB
Mobility is assessed by the SPPB, including gait speed(m/s) via the 4-meter test(s).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 4 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB
Mobility is assessed by the SPPB, including balance, measured via the balance test.
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: Baseline
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB
Mobility is assessed by the SPPB, including balance, measured via the balance test.
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 2 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB
Mobility is assessed by the SPPB, including balance, measured via the balance test.
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 4 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB
Mobility is assessed by the SPPB, including balance, measured via the balance test.
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: Baseline
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB
Mobility is assessed by the SPPB, including balance, measured via the balance test.
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 2 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB
Mobility is assessed by the SPPB, including balance, measured via the balance test.
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 4 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB
Mobility is assessed by the SPPB, including 5-times sit-to stand tests(s).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: Baseline
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB
Mobility is assessed by the SPPB, including 5-times sit-to stand tests(s).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 2 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB
Mobility is assessed by the SPPB, including 5-times sit-to stand tests(s).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 4 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB
Mobility is assessed by the SPPB, including 5-times sit-to stand tests(s).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: Baseline
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB
Mobility is assessed by the SPPB, including 5-times sit-to stand tests(s).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 2 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB
Mobility is assessed by the SPPB, including 5-times sit-to stand tests(s).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 4 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)
Cognition will be assessed by the MoCa(0-30/30), a tool covering different domains.
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: Baseline
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)
Cognition will be assessed by the MoCa(0-30/30), a tool covering different domains.
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 2 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)
Cognition will be assessed by the MoCa(0-30/30), a tool covering different domains.
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 4 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)
Cognition will be assessed by the MoCa(0-30/30), a tool covering different domains.
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: Baseline
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)
Cognition will be assessed by the MoCa(0-30/30), a tool covering different domains.
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 2 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)
Cognition will be assessed by the MoCa(0-30/30), a tool covering different domains.
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 4 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)
Dependency in basic activities of daily living will be scored on the Katz scale (6-24/24).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: Baseline
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)
Dependency in basic activities of daily living will be scored on the Katz scale (6-24/24).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 2 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)
Dependency in basic activities of daily living will be scored on the Katz scale (6-24/24).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 4 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)
Dependency in basic activities of daily living will be scored on the Katz scale (6-24/24).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: Baseline
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)
Dependency in basic activities of daily living will be scored on the Katz scale (6-24/24).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 2 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)
Dependency in basic activities of daily living will be scored on the Katz scale (6-24/24).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 4 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)
Dependency in instrumental activities of daily living will be scored on Lawton scale (9-27/27).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: Baseline
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)
Dependency in instrumental activities of daily living will be scored on Lawton scale (9-27/27).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 2 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)
Dependency in instrumental activities of daily living will be scored on Lawton scale (9-27/27).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 4 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)
Dependency in instrumental activities of daily living will be scored on Lawton scale (9-27/27).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: Baseline
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)
Dependency in instrumental activities of daily living will be scored on Lawton scale (9-27/27).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 2 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)
Dependency in instrumental activities of daily living will be scored on Lawton scale (9-27/27).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 4 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in quality of life (Qol) measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)
Qol will be scored on SarQol (short form, 14 items: 0-100/100, the higher, the better Qol)
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: Baseline
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)
Qol will be scored on SarQol (short form, 14 items: 0-100/100, the higher, the better Qol)
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 2 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)
Qol will be scored on SarQol (short form, 14 items: 0-100/100, the higher, the better Qol)
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 4 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)
Qol will be scored on SarQol (short form, 14 items: 0-100/100, the higher, the better Qol)
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: Baseline
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)
Qol will be scored on SarQol (short form, 14 items: 0-100/100, the higher, the better Qol)
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 2 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)
Qol will be scored on SarQol (short form, 14 items: 0-100/100, the higher, the better Qol)
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 4 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol).
Qol will be scored on Eq-5D-5L(0-35 \& VAS 0 (worst Qol) to 100 (best Qol)).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: Baseline
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol).
Qol will be scored on Eq-5D-5L(0-35 \& VAS 0 (worst Qol) to 100 (best Qol)).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 2 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol).
Qol will be scored on Eq-5D-5L(0-35 \& VAS 0 (worst Qol) to 100 (best Qol)).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 4 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol).
Qol will be scored on Eq-5D-5L(0-35 \& VAS 0 (worst Qol) to 100 (best Qol)).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: Baseline
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol).
Qol will be scored on Eq-5D-5L(0-35 \& VAS 0 (worst Qol) to 100 (best Qol)).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 2 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol).
Qol will be scored on Eq-5D-5L(0-35 \& VAS 0 (worst Qol) to 100 (best Qol)).
Vitality capacity:
Maximal grip strength(kPa) Respiratory muscle strength(cmH2O) Muscle fatigue resistance(s) Self-perceived fatigue questionnaire(Question(Q) 1: 1 Not tired, 7 Extremely tired; Q2: 1 No I don't agree, 7 Yes I agree \& MFI: 0 Not fatigue, 5 Fatigue)
Locomotor capacity:
Timed up and go(s) 4-meter gait speed(m/s) Balance test(progressive standing: first 2 tests: 0 Impossible, 1 Holding for 10s; last test: 0 Impossible, 1 Holding for >3s-<9s, 2 holding for 10s) 30-second chair stand(n)
Sensory capacity:
Hearing test(signal to noise technology) Vision test(rotating E test)
Cognitive capacity:
Orientation test(0 Incorrect, 1 Correct) Object naming from description(0 Incorrect, 1 Correct) Verbal fluency(n) 10-words immediate \& delayed recall(0 Incorrect, 1 Correct)
Psychological capacity:
Resilience questionnaire(1 Strongly disagree, 5 Strongly agree)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Ivan Bautmans
- Sponsor type
- University, hospital or other
- Collaborators
- Leiehome vzw, University Hospital, Antwerp, Universiteit Antwerpen, INNOVIRIS, AAL
- Responsible party
- Sponsor-investigator, Prof. Ivan Bautmans, Vrije Universiteit Brussel
- Investigators
- Ivan Bautmans, Prof. Dr., Principal investigator, VUB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270979
- Sponsor's protocol ID
- ISHA
- Acronym
- ISHA
- Status last verified
- Feb 2024
- First submitted
- 12 Jan 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Usability of Intrinsic Capacity Monitoring With an Integrated Data Eco-System for Healthy Ageing, and Its Association With Health Outcomes in Older Patients Undergoing Rehabilitation and in Older Nursing Home Residents.
- ClinicalTrials.gov ID
- NCT06270979
- Acronym / sponsor ID
- ISHA / ISHA
- Conditions
- Frailty
- Keywords
- Self-monitoring, Intrinsic capacity, Prevention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Prof. Ivan BautmansUniversity, hospital or other
- Collaborators
- Leiehome vzw, University Hospital, Antwerp, Universiteit Antwerpen, INNOVIRIS, AAL
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, 120 older adults (aged 65 years or older) either patients undergoing rehabilitation or older nursing home residents will be provided with an Eforto® device and the eco-System for Healthy Ageing (ISHA) mobile application to self-monitor intrinsic capacity for 4 months (if needed with assistance by an (in)formal caregiver). Preferably, the participants will use their own smartphone because mitigating smartphone-use-related issues.
The aims of the study are:
- to evaluate the usability and feasibility of self-monitoring intrinsic capacity by using the ISHA system in rehabilitation and nursing home settings.
- to investigate if changes and variability in intrinsic capacity as measured with ISHA are related to changes in functional ability and quality of life.
- to explore individual trajectories of intrinsic capacity with the ISHA system.
Detailed description
Investigational device:
The ISHA digital eco-system (class IIa investigational medical device).
ISHA consists of 3 components:
- An Eforto® device: a handheld grip work (GW) hardware device, composed of a rubber bulb, to be compressed by the user and plastic enclosure that holds the electronic components such as a pressure sensor, battery, and connectivity. A mouthpiece can be attached for respiratory capacity monitoring. The Eforto® system was developed based on approximatively 20 years of scientific research on handgrip muscle fatigability performed by the Frailty in Ageing research department (see https://fria.research.vub.be/) and in collaboration with top-level international partners. The Eforto® system allows self-assessment of muscle fatigability and self-perceived fatigue in older adults and functions as a monitoring tool for intrinsic capacity. It is a small device, easy to use, and suitable for home measurements as well as hospital settings. When used correctly, the measurements cause no discomfort and can be performed repeatedly. The Eforto® device connects to a smartphone application that provides verbal test instructions to the participant. The app will guide the participant during the test and automatically provide motivational cues via audio. The test results are aggregated and stored in a cloud platform where the researcher can manage subjects, access the test data and export it for further analysis.
- Mobile application that ensures connectivity and collection of data from the Eforto® device and by which multiple guided tests for the locomotor (maximal grip strength, respiratory muscle strength, muscle fatigue resistance test \& self-perceived fatigue questionnaire), sensory (hearing test (signal to noise technology) \& vision test (rotating E test), cognitive (orientation test, object naming from description, animal naming \& 10-words immediate and delayed recall), and psychological (resilience questionnaire) domains of intrinsic capacity can be completed. The app allows offline data collection and to synchronize with the third component, the remote monitoring platform. It serves as an interactive guidance and can be used by the subject/patient at home or assisted by a (formal or informal) caregiver.
- The remote monitoring platform serves mainly as a dashboard for monitoring the older end-users. Its main purpose is to centralize and monitor the collected data.
Procedures:
The study will be approved by the institutional review board's and all participants will sign informed consent.
After informed consent is given, the eligibility assessment and T0 (baseline) measurements will take place. These measurements will be re-assessed after 2 months and 4 months.
During this test moments the participant will be asked to perform the ISHA-tests (intrinsic domains: vitality, locomotor, sensory, cognitive and psychological). Other tests that will be assessed are: anthropometry (body weight \& height and waist \& hip circumference), health status (medical history, Center for Epidemiologic Studies Depression scale (CES-D), Mini Mental State Examination (MMSE), fall incidents, hospital admissions, Mini Nutritional Assessment (MNA) and orthostatic test), Frailty (Fried Criteria), functional dependency tests (Montreal Cognitive Assessment (MOCA), basic activity of daily living (ADL) (Katz), instrumental ADL (Lawton) and Short Physical Performance Test (SPPB)), questionnaires (Sarcopenia Quality of life questionnaire (SarQol), Eq-5D-5L, International Physical Activity Questionnaire (IPAQ), health-economic questionnaire and general health questions) and technical problem/ usability, feasibility and expectations questionnaires. In the context of eligible check, the smartphone experiences and personal data e.g. sex, birth day date, living situation will be asked.
After an individual information session with training on the ISHA test battery and instructions for ISHA use in self-test mode, the participant will be instructed to perform the ISHA measurements for 4 months at their home (if needed with assistance by an (in)formal caregiver). Preferentially, the healthcare professional (occupational therapist, physical therapist, study nurse) will install the ISHA application on the smartphone of the participant. If during the individual information session, the participant is unable to correctly operate the ISHA tool, the healthcare professional will explore together with the participant whether a (informal or formal) caregiver could aid, and eventually the participant will be re-invited together with his/her informal caregiver for another information/training session. If correct use of the ISHA system by the participant and/or assistance by a caregiver is impossible, the participant will be excluded for further participation in the study.
The self-test measurements will be continued for 4 months or until withdrawal of the participant. The self-tests will be performed:
- weekly on 2 consecutive days per week for vitality capacity;
- once every two weeks for locomotor capacity, and
- once every month for sensory, cognitive, and psychological capacity.
The application will give a reminder to the participant every time he/she needs to do the ISHA measurements.
During the study, participants will be contacted every month by a researcher to register any changes in health situation as well as technical issues encountered during the self-testing.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leiehome vzw | – | Device: ISHAParticipant recruitment entails including persons aged 65 years or older living in an assisted housing or a nursing home. |
| University Hospital Antwerp/University of Antwerp | – | Device: ISHAParticipant recruitment entails including persons aged 65 years or older undergoing rehabilitation at University Hospital Antwerp. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients undergoing rehabilitation and nursing home residents, all aged 65 years or older.
Key inclusion criteria (9 listed)
- Aged 65 years or older.
- Patients living independently at home and undergoing rehabilitation, or older persons living in the residential care community (in a nursing home or in assisted housing).
- Being able to operate the basic functions of a smartphone (if needed with assistance by an informal caregiver): using a smartphone at least for calls, and minimum 1 other application.
- Understanding Dutch.
- Being unable to perform the physical (self)tests (e.g., unable to stand up or walk);
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISHAParticipants will be provided with an Eforto® device and ISHA mobile application to self-monitor intrinsic capacity for 4 months (if needed with assistance by an (in)formal caregiver). | Device | Leiehome vzw, University Hospital Antwerp/University of Antwerp |
Primary outcome
Potential technical problems of the ISHA system
Time frame: Week 1
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Potential technical problems of the ISHA system
Time frame: Week 2
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Potential technical problems of the ISHA system
Time frame: Week 3
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Potential technical problems of the ISHA system
Time frame: Week 4
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Potential technical problems of the ISHA system
Time frame: Week 5
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Potential technical problems of the ISHA system
Time frame: Week 6
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Potential technical problems of the ISHA system
Time frame: Week 7
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Potential technical problems of the ISHA system
Time frame: Week 8
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Potential technical problems of the ISHA system
Time frame: Week 9
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Potential technical problems of the ISHA system
Time frame: Week 10
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Potential technical problems of the ISHA system
Time frame: Week 11
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Potential technical problems of the ISHA system
Time frame: Week 12
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Potential technical problems of the ISHA system
Time frame: Week 13
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Potential technical problems of the ISHA system
Time frame: Week 14
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Potential technical problems of the ISHA system
Time frame: Week 15
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Potential technical problems of the ISHA system
Time frame: Week 16
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Experiences with ISHA (usability, feasibility and acceptability outcome)
Time frame: End of the study (week 16)
An self-reported questionnaire (19 questions) based on the System Usability Scale (SUS). Options for answer: 1-5. 1 is 'Strongly disagree', 5 is 'Strongly agree'.
48 secondary outcomes
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB
Time frame: Baseline
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB
Time frame: 2 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB
Time frame: 4 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB
Time frame: Baseline
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB
Time frame: 2 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB
Time frame: 4 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB
Time frame: Baseline
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB
Time frame: 2 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB
Time frame: 4 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB
Time frame: Baseline
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB
Time frame: 2 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB
Time frame: 4 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB
Time frame: Baseline
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB
Time frame: 2 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB
Time frame: 4 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB
Time frame: Baseline
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB
Time frame: 2 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB
Time frame: 4 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)
Time frame: Baseline
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)
Time frame: 2 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)
Time frame: 4 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)
Time frame: Baseline
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)
Time frame: 2 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)
Time frame: 4 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)
Time frame: Baseline
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)
Time frame: 2 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)
Time frame: 4 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)
Time frame: Baseline
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)
Time frame: 2 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)
Time frame: 4 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)
Time frame: Baseline
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)
Time frame: 2 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)
Time frame: 4 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)
Time frame: Baseline
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)
Time frame: 2 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)
Time frame: 4 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in quality of life (Qol) measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)
Time frame: Baseline
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)
Time frame: 2 months
The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)
Time frame: 4 months
The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Frailty \& resilience in ageing research group VUB siteLink provided by the sponsor.
- ISHA-AAL siteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan Bautmans, Prof. Dr. principal investigator
VUB
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty, run by Prof. Ivan Bautmans.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivan Bautmans, Prof. Dr. (+32 (0)2 477 42 07, Ivan.Bautmans@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potential technical problems of the ISHA system (time frame: Week 1). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.