FrailtyNCT06385041
Cardiac Rehabilitation and Frailty Physical Training Program in Elderly Patients After Open Heart Surgery
A study testing Multicomponent training group and Computer-based interactive training group in people with Frailty and Surgery, run by Vitalija Stonkuvienė at 1 site in Lithuania.
Trial summary
The aim of the research - to evaluate the impact of interactive physical therapy tools for functional capacity, fear of falls, motivation and quality of life after open heart surgery due to ischemic heart disease and frailty in the second stage of rehabilitation. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- Multicomponent training group and Computer-based interactive training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteLithuania
- Study dates
- 22 Jul 2021to 22 May 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- Patient's agreement to participate in the study,
- Age 65 years and older,
- Patients admitted to cardiac rehabilitation after open heart surgery,
- Patients with frailty (Edmonton frailty scale ≥4)
- 6-minute walk distance (6-MWD) ≥150 meters and walking without mobility aid.
Who cannot join
- Patient's disagreement to participate in the study
- Exercise-limiting comorbidities (primarily orthopedic and neurological conditions that would exclude individuals from participating in cardiac rehabilitation according to study protocol), cognitive, vision, linguistic deficits, chronic heart failure Class IV, anemia, wound healing disturbance or other various acute conditions that may limit active participation in physical therapy programs.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
Kaunas
About this study
Official title: Impact of Interactive Physical Therapy for Functional Capacity, Fear of Falls, Motivation and Quality of Life After Open Heart Surgery Due to Ischemic Heart Disease and Frailty in the Second Stage of Rehabilitation.
The aim of the research - to evaluate the impact of interactive physical therapy tools for functional capacity, fear of falls, motivation and quality of life after open heart surgery due to ischemic heart disease and frailty in the second stage of rehabilitation.
Read the detailed description
The clinical trial will be performed during patient rehabilitation. All examination of the patient will be performed before rehabilitation and at the end of rehabilitation. Total subjects will spend 20 days in rehabilitation. All subjects who will have frailty syndrome will be assigned to one of three groups: control, intervention group-1 or intervention group-2.
- Being tested
- Multicomponent training group, Computer-based interactive training group
- Keywords
- frailty syndrome, open heart surgery, cardiac rehabilitation
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent training groupOther
Additional exercise program with balance and strength trainings will include 3 times/week. Patients will get an individualized exercise program for frailty syndrome, which will include strength exercises (with elastic resistance bands and weights up to 2kg 30-50% 1RM) and balance training (with unstable surfaces). The program will be performed by 3 sets with 10 repetitions 3 times/week 30-45 minutes.
Computer-based interactive training groupOther
Additional exercise program with balance and strength trainings will include 3 times/week 30-45 minutes. Patients will get an individualized program for frailty syndrome, with interactive technologies: gait training with Biodex GaitTrainerTM3 with visual, audio feedback and incline up to 10-15 min, Zebris FDM-T, with virtual barriers, thus simulating real environment for the patient, while performing a cognitive task up to 10-15 min, for balance training investigators used a computerized Biodex board. Exercises will be performed with the programs: Postural stability training, Limits of stability training, Weight shift training, Maze control training, Random control training, Percent weight-bearing training. For strength training investigators used equipment HUR based on pneumatic (air pressure) technology. For strength training intensity 30-50% 1-RM, 10 repetitions with 3 sets. Leg press, leg extension, leg abduction, leg adduction will be performed with pneumatic technology.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Physical training program will include: dosed aerobic training program on cycle ergometers (6 days/week, for 10-30 minutes, 30-50% watts or 30-50% HRmax). The training program consists individually according to the person state of health and respiratory muscle training (7 days/week, for 15 minutes). |
| Multicomponent training group | Experimental | Physical training program will include: dosed aerobic training program on cycle ergometers and respiratory muscle trainings as in control group. Also patients will get an individualized exercise program for frailty syndrome, which will include strength exercises (with elastic resistance bands and weights) and balance training (unstable surfaces) 3 times/week 30-45 minutes. Receives: Other: Multicomponent training group |
| Computer-based interactive training group | Experimental | Physical training program will include: dosed aerobic training program on cycle ergometers and respiratory muscle trainings as in control group. Also patients will get an individualized program for frailty syndrome, with the help of interactive technologies 3 times/week. 30-45 minutes (gait training with Biodex GaitTrainerTM3 with visual and audio feedback, Zebris FDM-T, with the help of which virtual barriers are created, thus simulating real environment for the patient, while performing a cognitive task, for balance training investigators used a computerized Biodex board. For strength training investigators used equipment HUR based on pneumatic (air pressure) technology. Receives: Other: Computer-based interactive training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collecting data from the medical history
comorbidities, date of surgery, etc. only with the subject's agreement
Measured: baseline
Frailty level by Edmonton frail scale score
The Edmonton frail scale assesses 9 domains: cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance. Frailty level is measured by the Edmonton frail scale score - 0-3 - fit, 4-5 - vulnerable, 6-7 - mild frailty, 8-9 - moderate frailty,10-17 - severe frailty.
Measured: baseline
Fear of Falling by Falls Efficacy Scale International; FES-I).
The FES-1 was used to assess the fear of falling level of participants about falling during indoor or outdoor activities. It has 16 items scored on a four-point Likert scale. assess the fear of falling level of participants about falling during indoor or outdoor activities minimum score 16 maximum score 64. The level of concern for each item is scored on a 4-point scale (1: not at all, 2: somewhat, 3: quite a lot, 4: very), with the total score range being 16 to 64.The results are divided into 3 parts: low 16-19, moderate 20-27, and high concern 28-64 points.
Measured: baseline, 20 days.
Quality of life by EuroQoL FiveDimensionsEQ-5D-5L.
The EQ-5D-5L consists of 2 parts: descriptive system and visual analogue scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS (visual analogue scale) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measured: baseline, 20 days.
Motivation by Multidimensional Health Locus of Control scale
It is one of the most commonly-used parameters of health belief in planning the health education programs. The health locus of control is the degree to which individual believe that his or her behavior is controlled by external or internal factors. The survey contains with 18 items and consist of three subscales, namely Internal Health Locus of Control, Powerful Others Health Locus of Control, and Chance Health Locus of Control. Each of these subscales contains six items with a six-point Likert response scale ranging from 'Strongly Agree' to 'Strongly Disagree'. Scores for each subscale reflect the total score for the corresponding 6 items, with subscales having a minimum score of 6 and maximum score of 36.
Measured: baseline, 20 days.
Change from baseline functional capacity by six minutes walking test (6MWT)
6MWT measured by meters. This test is performed preferably indoors, on a flat, straight,hard-surfaced corridor usually at least 30m long. The patient is told to be wear comfortable clothing and shoes. The physical therapist records heart rate and brachial arterial blood pressure and the Borg scale rating for dyspnea and fatigue before and after the test.
Measured: baseline, 20 days.
Change from baseline physical performance by Short Physical Performance Battery (SPPB)
The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests.The scores range from 0 (worst performance) to 12 (best performance).
Measured: baseline, 20 days.
Change from baseline muscular strength by one repetition maximum test (1RM)
1RM test for leg press is measured by kilograms. The one-repetition maximum (1RM) test is often considered as the 'gold standard' for assessing the strength capacity of individuals. It is simply defined as the maximal weight an individual can lift for only one repetition with correct technique.The 1RM machine leg press is often used as a measure of maximal lower body strength with older subjects.
Measured: baseline, 20 days.
Change from baseline grip strength by hydraulic hand dynamometer
Grip muscle strength will be measured by kilograms.
Measured: baseline, 20 days.
Change from baseline balance parameters by Biodex Balance System SD
Using Biodex Balance system with stable and unstable surface with open and closed eyes balance tests are performed (Limits of Stability, Fall Risk, Modified Clinical Test of Sensory Integration and Balance, Balance Error Scoring System).
Measured: baseline, 20 days.
Change from baseline stance and gait parameters by Zebris Medical GmbH
Using Zebris medical GmbH platform stance and gait parameters are measured. It includes average forces for left and right foot, max load of body weight, foot rotation degree, Step length,Stride length,Step width,Stance, Swing and Double stance phases parameters, Step time,Stride time,Cadence,Velocity,Length of gait line,Single limb support line,Ant/post position,Lateral symmetry,Max gait line velocity,Force parameters, Load change, Maximum force, Maximum pressure,Time maximum force,Contact time.
Measured: baseline, 20 days.
Secondary outcomes (2)
Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt)
Maximal load measured with spiroergometry by maximal watts.
Measured: baseline, 20 days.
Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute.
Measured: baseline, 20 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start22 Jul 2021
- Primary completion22 May 2024
- Study completion22 May 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitalija Stonkuvienė
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vitalija Stonkuvienė, Lithuanian University of Health Sciences
- Investigators
- Raimondas Kubilius, prof, MD, Principal investigator, LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385041
- Sponsor's protocol ID
- BE-2-83
- Status last verified
- Sep 2025
- First submitted
- 23 Apr 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Interactive Physical Therapy for Functional Capacity, Fear of Falls, Motivation and Quality of Life After Open Heart Surgery Due to Ischemic Heart Disease and Frailty in the Second Stage of Rehabilitation.
- ClinicalTrials.gov ID
- NCT06385041
- Acronym / sponsor ID
- BE-2-83
- Keywords
- frailty syndrome, open heart surgery, cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Vitalija StonkuvienėUniversity, hospital or other
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 25 Apr 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.
The aim of the research - to evaluate the impact of interactive physical therapy tools for functional capacity, fear of falls, motivation and quality of life after open heart surgery due to ischemic heart disease and frailty in the second stage of rehabilitation.
Detailed description
The clinical trial will be performed during patient rehabilitation. All examination of the patient will be performed before rehabilitation and at the end of rehabilitation. Total subjects will spend 20 days in rehabilitation. All subjects who will have frailty syndrome will be assigned to one of three groups: control, intervention group-1 or intervention group-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Physical training program will include: dosed aerobic training program on cycle ergometers (6 days/week, for 10-30 minutes, 30-50% watts or 30-50% HRmax). The training program consists individually according to the person state of health and respiratory muscle training (7 days/week, for 15 minutes). |
| Multicomponent training group | Experimental | Other: Multicomponent training groupPhysical training program will include: dosed aerobic training program on cycle ergometers and respiratory muscle trainings as in control group. Also patients will get an individualized exercise program for frailty syndrome, which will include strength exercises (with elastic resistance bands and weights) and balance training (unstable surfaces) 3 times/week 30-45 minutes. |
| Computer-based interactive training group | Experimental | Other: Computer-based interactive training groupPhysical training program will include: dosed aerobic training program on cycle ergometers and respiratory muscle trainings as in control group. Also patients will get an individualized program for frailty syndrome, with the help of interactive technologies 3 times/week. 30-45 minutes (gait training with Biodex GaitTrainerTM3 with visual and audio feedback, Zebris FDM-T, with the help of which virtual barriers are created, thus simulating real environment for the patient, while performing a cognitive task, for balance training investigators used a computerized Biodex board. For strength training investigators used equipment HUR based on pneumatic (air pressure) technology. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patient's agreement to participate in the study,
- Age 65 years and older,
- Patients admitted to cardiac rehabilitation after open heart surgery,
- Patients with frailty (Edmonton frailty scale ≥4)
- 6-minute walk distance (6-MWD) ≥150 meters and walking without mobility aid.
Key exclusion criteria (2 listed)
- Patient's disagreement to participate in the study
- Exercise-limiting comorbidities (primarily orthopedic and neurological conditions that would exclude individuals from participating in cardiac rehabilitation according to study protocol), cognitive, vision, linguistic deficits, chronic heart failure Class IV, anemia, wound healing disturbance or other various acute conditions that may limit active participation in physical therapy programs.
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 |
|---|---|---|
| Multicomponent training groupAdditional exercise program with balance and strength trainings will include 3 times/week. Patients will get an individualized exercise program for frailty syndrome, which will include strength exercises (with elastic resistance bands and weights up to 2kg 30-50% 1RM) and balance training (with unstable surfaces). The program will be performed by 3 sets with 10 repetitions 3 times/week 30-45 minutes. | Other | Multicomponent training group |
| Computer-based interactive training groupAdditional exercise program with balance and strength trainings will include 3 times/week 30-45 minutes. Patients will get an individualized program for frailty syndrome, with interactive technologies: gait training with Biodex GaitTrainerTM3 with visual, audio feedback and incline up to 10-15 min, Zebris FDM-T, with virtual barriers, thus simulating real environment for the patient, while performing a cognitive task up to 10-15 min, for balance training investigators used a computerized Biodex board. Exercises will be performed with the programs: Postural stability training, Limits of stability training, Weight shift training, Maze control training, Random control training, Percent weight-bearing training. For strength training investigators used equipment HUR based on pneumatic (air pressure) technology. For strength training intensity 30-50% 1-RM, 10 repetitions with 3 sets. Leg press, leg extension, leg abduction, leg adduction will be performed with pneumatic technology. | Other | Computer-based interactive training group |
Primary outcome
Collecting data from the medical history
Time frame: baseline
comorbidities, date of surgery, etc. only with the subject's agreement
Frailty level by Edmonton frail scale score
Time frame: baseline
The Edmonton frail scale assesses 9 domains: cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance. Frailty level is measured by the Edmonton frail scale score - 0-3 - fit, 4-5 - vulnerable, 6-7 - mild frailty, 8-9 - moderate frailty,10-17 - severe frailty.
Fear of Falling by Falls Efficacy Scale International; FES-I).
Time frame: baseline, 20 days.
The FES-1 was used to assess the fear of falling level of participants about falling during indoor or outdoor activities. It has 16 items scored on a four-point Likert scale. assess the fear of falling level of participants about falling during indoor or outdoor activities minimum score 16 maximum score 64. The level of concern for each item is scored on a 4-point scale (1: not at all, 2: somewhat, 3: quite a lot, 4: very), with the total score range being 16 to 64.The results are divided into 3 parts: low 16-19, moderate 20-27, and high concern 28-64 points.
Quality of life by EuroQoL FiveDimensionsEQ-5D-5L.
Time frame: baseline, 20 days.
The EQ-5D-5L consists of 2 parts: descriptive system and visual analogue scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS (visual analogue scale) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Motivation by Multidimensional Health Locus of Control scale
Time frame: baseline, 20 days.
It is one of the most commonly-used parameters of health belief in planning the health education programs. The health locus of control is the degree to which individual believe that his or her behavior is controlled by external or internal factors. The survey contains with 18 items and consist of three subscales, namely Internal Health Locus of Control, Powerful Others Health Locus of Control, and Chance Health Locus of Control. Each of these subscales contains six items with a six-point Likert response scale ranging from 'Strongly Agree' to 'Strongly Disagree'. Scores for each subscale reflect the total score for the corresponding 6 items, with subscales having a minimum score of 6 and maximum score of 36.
Change from baseline functional capacity by six minutes walking test (6MWT)
Time frame: baseline, 20 days.
6MWT measured by meters. This test is performed preferably indoors, on a flat, straight,hard-surfaced corridor usually at least 30m long. The patient is told to be wear comfortable clothing and shoes. The physical therapist records heart rate and brachial arterial blood pressure and the Borg scale rating for dyspnea and fatigue before and after the test.
Change from baseline physical performance by Short Physical Performance Battery (SPPB)
Time frame: baseline, 20 days.
The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests.The scores range from 0 (worst performance) to 12 (best performance).
Change from baseline muscular strength by one repetition maximum test (1RM)
Time frame: baseline, 20 days.
1RM test for leg press is measured by kilograms. The one-repetition maximum (1RM) test is often considered as the 'gold standard' for assessing the strength capacity of individuals. It is simply defined as the maximal weight an individual can lift for only one repetition with correct technique.The 1RM machine leg press is often used as a measure of maximal lower body strength with older subjects.
Change from baseline grip strength by hydraulic hand dynamometer
Time frame: baseline, 20 days.
Grip muscle strength will be measured by kilograms.
Change from baseline balance parameters by Biodex Balance System SD
Time frame: baseline, 20 days.
Using Biodex Balance system with stable and unstable surface with open and closed eyes balance tests are performed (Limits of Stability, Fall Risk, Modified Clinical Test of Sensory Integration and Balance, Balance Error Scoring System).
Change from baseline stance and gait parameters by Zebris Medical GmbH
Time frame: baseline, 20 days.
Using Zebris medical GmbH platform stance and gait parameters are measured. It includes average forces for left and right foot, max load of body weight, foot rotation degree, Step length,Stride length,Step width,Stance, Swing and Double stance phases parameters, Step time,Stride time,Cadence,Velocity,Length of gait line,Single limb support line,Ant/post position,Lateral symmetry,Max gait line velocity,Force parameters, Load change, Maximum force, Maximum pressure,Time maximum force,Contact time.
2 secondary outcomes
Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt)
Time frame: baseline, 20 days.
Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
Time frame: baseline, 20 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
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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.
Raimondas Kubilius, prof, MD principal investigator
LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent training group and Computer-based interactive training group in people with Frailty and Surgery, run by Vitalija Stonkuvienė at 1 site in Lithuania.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collecting data from the medical history (time frame: baseline). The study lists 11 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 11 Sep 2025.