Mild Cognitive ImpairmentNCT04692974
Cognitive Frailty in Older Adults: The Role of Technology in Physical Activity Enhancement
A study testing Mobile phone application and smart watch in people with Mild Cognitive Impairment and Frailty, run by National University of Singapore at 1 site in Singapore.
Trial summary
This study intends to determine if smart watches and mobile phone application prompts can complement physical activity as a preventive intervention by motivating participants to exercise, so as to improve their physical and cognitive outcomes. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Frailty
- What is being tested?
- Mobile phone application and smart watch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Dec 2020to Aug 2021
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older adults aged 60 to 85 years
Who cannot join
- Engages in vigorous exercises as determined by having more than 0 minutes of vigorous exercise on the International Physical Activity Questionnaire (IPAQ).
- Has medical contraindications for exercising, including but not limited to: physical disabilities or heart conditions where the primary doctor disallows exercising at moderate intensity.
- Does not own an Android phone which can support at least a version 6.0 Operating System
Trial locations and contacts
1 site in 1 country.
Rathi Mahendran, MMed (Psych) contact
Singapore1 site, 1 recruiting
- Recruiting
Hannah Senior Activity Center
Singapore, 590021
Savannah Siew, BSc (Hons), 90697618, savannahsiew@nus.edu.sg
Rathi Mahendran, MMed (Psych)
About this study
Official title: Cognitive Frailty in Older Adults: Protocol of a Pilot RCT of the Role of Technology in Physical Activity Enhancement
This study intends to determine if smart watches and mobile phone application prompts can complement physical activity as a preventive intervention by motivating participants to exercise, so as to improve their physical and cognitive outcomes.
The investigators hypothesize that technology will help increase engagement in physical activity for the intervention group relative to the control group and subsequently improve cognitive and physical outcomes.
Read the detailed description
This study aims to explore the role of technology -- in the form of smart watches and mobile phone application -- in physical activity enhancement on cognitive frailty outcomes. Cognitive frailty is defined here as having both physical frailty and cognitive impairment but does not satisfy criteria for Major Neurocognitive Disorder. The investigators postulate that for older adults, such technology will help increase engagement in physical activity with subsequent improvement in cognitive and physical outcomes at follow up. This is with the aim of preventing this particular group from deteriorating to cognitive frailty because of the accompanying increased risk for adverse outcomes and morbidity.
This pilot study will be a randomized control trial with 2 treatment arms. Assessments will be done prior to and following the intervention period. During the period of intervention, the wearable will act as a tracking device and will be paired with a mobile application to issue prompts to the participant when necessary. The independent variable explored in the study is the use of the wearable while the levels of physical and cognitive improvements are the dependent measures. These will be tracked at baseline, 3 months and 6 months. Additionally, the mediating variable measured is the levels of physical activity to ensure that the proposed outcomes are affected through an increased level of physical activity encouraged by the use of the device.
If innovations like technology and the role of self-management proves efficacious, the future of healthcare in the context of a rapidly aging population will be more sustainable. Furthermore, this supporting role of technology in positive behavioral modification amongst older adults can have a multitude of applications in subsequent healthcare interventions.
- Conditions
- Mild Cognitive Impairment, Frailty
- Being tested
- Mobile phone application and smart watch
- Keywords
- Cognitive Frailty, Physical Frailty, Physical Activity, Mild Cognitive Impairment, Technology
- Medical subject headings
- Cognitive Dysfunction, Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone application and smart watchDevice
Mobile phone application prompts
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group will be given the wearables which they will use together with the accompanying mobile application for the period of the study (6 months). During the period of intervention, the wearable will track the physical activity of the older adults via the number of steps taken and number of hours of moderate physical work (based on heart rate). Heart rate and steps will be tracked whenever participants are wearing the watch, which is when they are awake. The watch is to be charged every night when they are sleeping. Participants will have to log down their physical activity by activating the physical activity tracker either on the watch or on the mobile application. If they did not hit the required level of physical activity, they will be sent a notification prompt through the mobile application with details of nearby workout locations as recommendation. Receives: Device: Mobile phone application and smart watch |
| Control Group | No intervention | For the control group, they will wear the wearables as a tracking device for the period of the study (6 months). No prompts will be given and the mobile application will only be installed but not used for this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in frailty screening scores on the FRAIL questionnaire at 3 and 6 months
5 questions on fatigue, resistance, ambulation, illness and loss of weight. It is a simple screening test for frailty. Scores of 0 (non-frail), 1-2 (pre-frail) and 3-5 (frail).
Measured: At 3 months and 6 months
Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months
Hand grip strength in kilograms
Measured: At 3 months and 6 months
Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months
Gait speed, time taken to walk a specified distance as fast as possible, in seconds
Measured: At 3 months and 6 months
Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months
Timed Up and Go (TUG), time taken to stand up from a chair, walk 3 meters, turn around and sit back down, in seconds
Measured: At 3 months and 6 months
Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months
Chair Stand Test, time taken to stand up fully 5 times from a chair in seconds
Measured: At 3 months and 6 months
Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
Rey Auditory Verbal Learning Test (RAVLT) assesses verbal learning and memory
Measured: At 3 months and 6 months
Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
Digit Span Forward and Backward (DS) assesses working memory capacity
Measured: At 3 months and 6 months
Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
Colour Trails Test (CTT) assesses visual-spatial skills and attention
Measured: At 3 months and 6 months
Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
Wechsler's Block Design (WBS) assesses visuospatial ability
Measured: At 3 months and 6 months
Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
Semantic Fluency - animals (SFA) assesses semantic memory
Measured: At 3 months and 6 months
Secondary outcomes (3)
Mean Change from Baseline in Steps Taken measured by the smart watch at 3 months and 6 months
Number of steps taken daily
Measured: At 3 months and 6 months
Mean Change from Baseline in moderate exercise measured by the smart watch at 3 months and 6 months
Minutes of moderate exercise in a week
Measured: At 3 months and 6 months
Mean Change from Baseline in levels of physical activity measured by the "International Physical Activity Questionnaire" at 3 months and 6 months
Self-reported minutes and hours of vigorous or moderate exercise
Measured: At 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start15 Dec 2020
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention and control group design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Sengkang General Hospital
- Responsible party
- Principal investigator, Rathi Mahendran, National University of Singapore
- Investigators
- Rathi Mahendran, MMed (Psych), Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692974
- Sponsor's protocol ID
- H-20-038
- Status last verified
- Apr 2021
- First submitted
- 10 Dec 2020
- Last updated
- 19 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee KY, Siew S, Teo TL, Chua KC, Yu J, Mahendran R, Rawtaer I. Effect of wearables with behavioral prompts on physical and cognitive outcomes in community-dwelling older adults: preliminary results of a pilot randomized controlled trial. Front Sports Act Living. 2026 Aug 25;8:1768808. doi: 10.3389/fspor.2026.1768808. eCollection 2026.
PubMed 42713397Kiah Hui Siew S, Yu J, Teo TL, Chua KC, Mahendran R, Rawtaer I. Technology and physical activity for preventing cognitive and physical decline in older adults: Protocol of a pilot RCT. PLoS One. 2024 Feb 23;19(2):e0293340. doi: 10.1371/journal.pone.0293340. eCollection 2024.
PubMed 38394113
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Frailty in Older Adults: Protocol of a Pilot RCT of the Role of Technology in Physical Activity Enhancement
- ClinicalTrials.gov ID
- NCT04692974
- Acronym / sponsor ID
- H-20-038
- Conditions
- Mild Cognitive Impairment, Frailty
- Keywords
- Cognitive Frailty, Physical Frailty, Physical Activity, Mild Cognitive Impairment, Technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Sengkang General Hospital
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 5 Jan 2021 (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.
This study intends to determine if smart watches and mobile phone application prompts can complement physical activity as a preventive intervention by motivating participants to exercise, so as to improve their physical and cognitive outcomes.
The investigators hypothesize that technology will help increase engagement in physical activity for the intervention group relative to the control group and subsequently improve cognitive and physical outcomes.
Detailed description
This study aims to explore the role of technology -- in the form of smart watches and mobile phone application -- in physical activity enhancement on cognitive frailty outcomes. Cognitive frailty is defined here as having both physical frailty and cognitive impairment but does not satisfy criteria for Major Neurocognitive Disorder. The investigators postulate that for older adults, such technology will help increase engagement in physical activity with subsequent improvement in cognitive and physical outcomes at follow up. This is with the aim of preventing this particular group from deteriorating to cognitive frailty because of the accompanying increased risk for adverse outcomes and morbidity.
This pilot study will be a randomized control trial with 2 treatment arms. Assessments will be done prior to and following the intervention period. During the period of intervention, the wearable will act as a tracking device and will be paired with a mobile application to issue prompts to the participant when necessary. The independent variable explored in the study is the use of the wearable while the levels of physical and cognitive improvements are the dependent measures. These will be tracked at baseline, 3 months and 6 months. Additionally, the mediating variable measured is the levels of physical activity to ensure that the proposed outcomes are affected through an increased level of physical activity encouraged by the use of the device.
If innovations like technology and the role of self-management proves efficacious, the future of healthcare in the context of a rapidly aging population will be more sustainable. Furthermore, this supporting role of technology in positive behavioral modification amongst older adults can have a multitude of applications in subsequent healthcare interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention and control group design
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Mobile phone application and smart watchParticipants in the intervention group will be given the wearables which they will use together with the accompanying mobile application for the period of the study (6 months). During the period of intervention, the wearable will track the physical activity of the older adults via the number of steps taken and number of hours of moderate physical work (based on heart rate). Heart rate and steps will be tracked whenever participants are wearing the watch, which is when they are awake. The watch is to be charged every night when they are sleeping. Participants will have to log down their physical activity by activating the physical activity tracker either on the watch or on the mobile application. If they did not hit the required level of physical activity, they will be sent a notification prompt through the mobile application with details of nearby workout locations as recommendation. |
| Control Group | No intervention | –For the control group, they will wear the wearables as a tracking device for the period of the study (6 months). No prompts will be given and the mobile application will only be installed but not used for this group. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Older adults aged 60 to 85 years
Key exclusion criteria (3 listed)
- Engages in vigorous exercises as determined by having more than 0 minutes of vigorous exercise on the International Physical Activity Questionnaire (IPAQ).
- Has medical contraindications for exercising, including but not limited to: physical disabilities or heart conditions where the primary doctor disallows exercising at moderate intensity.
- Does not own an Android phone which can support at least a version 6.0 Operating System
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 |
|---|---|---|
| Mobile phone application and smart watchMobile phone application prompts | Device | Intervention Group |
Primary outcome
Mean Change from Baseline in frailty screening scores on the FRAIL questionnaire at 3 and 6 months
Time frame: At 3 months and 6 months
5 questions on fatigue, resistance, ambulation, illness and loss of weight. It is a simple screening test for frailty. Scores of 0 (non-frail), 1-2 (pre-frail) and 3-5 (frail).
Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months
Time frame: At 3 months and 6 months
Hand grip strength in kilograms
Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months
Time frame: At 3 months and 6 months
Gait speed, time taken to walk a specified distance as fast as possible, in seconds
Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months
Time frame: At 3 months and 6 months
Timed Up and Go (TUG), time taken to stand up from a chair, walk 3 meters, turn around and sit back down, in seconds
Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months
Time frame: At 3 months and 6 months
Chair Stand Test, time taken to stand up fully 5 times from a chair in seconds
Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
Time frame: At 3 months and 6 months
Rey Auditory Verbal Learning Test (RAVLT) assesses verbal learning and memory
Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
Time frame: At 3 months and 6 months
Digit Span Forward and Backward (DS) assesses working memory capacity
Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
Time frame: At 3 months and 6 months
Colour Trails Test (CTT) assesses visual-spatial skills and attention
Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
Time frame: At 3 months and 6 months
Wechsler's Block Design (WBS) assesses visuospatial ability
Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
Time frame: At 3 months and 6 months
Semantic Fluency - animals (SFA) assesses semantic memory
3 secondary outcomes
Mean Change from Baseline in Steps Taken measured by the smart watch at 3 months and 6 months
Time frame: At 3 months and 6 months
Mean Change from Baseline in moderate exercise measured by the smart watch at 3 months and 6 months
Time frame: At 3 months and 6 months
Mean Change from Baseline in levels of physical activity measured by the "International Physical Activity Questionnaire" at 3 months and 6 months
Time frame: At 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Derived from this study: PubMed 42713397Lee KY, Siew S, Teo TL, Chua KC, Yu J, Mahendran R, Rawtaer I. Effect of wearables with behavioral prompts on physical and cognitive outcomes in community-dwelling older adults: preliminary results of a pilot randomized controlled trial. Front Sports Act Living. 2026 Aug 25;8:1768808. doi: 10.3389/fspor.2026.1768808. eCollection 2026.
- Derived from this study: PubMed 38394113Kiah Hui Siew S, Yu J, Teo TL, Chua KC, Mahendran R, Rawtaer I. Technology and physical activity for preventing cognitive and physical decline in older adults: Protocol of a pilot RCT. PLoS One. 2024 Feb 23;19(2):e0293340. doi: 10.1371/journal.pone.0293340. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Rathi Mahendran, MMed (Psych) contact
Rathi Mahendran, MMed (Psych) principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone application and smart watch in people with Mild Cognitive Impairment and Frailty, run by National University of Singapore at 1 site in Singapore.
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 1 inclusion and 3 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 19 Apr 2021. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Savannah Siew, BSc (Hons) (90697618, savannahsiew@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline in frailty screening scores on the FRAIL questionnaire at 3 and 6 months (time frame: At 3 months and 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04692974, which also lists 2 linked publications.
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 19 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.