FrailtyFITWISENCT07519642
Frailty Improvement Through Technology With Informal Caregiver Supported Exercise (FITWISE) for Pre-frail and Frail Community-dwelling Older Adults
A study testing FITWISE and Psychosocial support in people with Frailty and Pre-Frailty, run by National University of Singapore at 2 sites in Singapore.
Trial summary
The goal of this pilot trial is to evaluate the feasibility and potential effectiveness of a caregiver-mediated, technology-facilitated home-based intervention named Frailty Improvement through Technology With Informal Caregiver Supported Exercise (FITWISE) for pre-frail and frail community-dwelling older adults aged… Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Frailty, Pre-Frailty
- What is being tested?
- FITWISE and Psychosocial support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 Feb 2027to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Recruited from Lions Befrienders Active Aging Centres (AACs) or Tzu Chi Active Aging Centres (AACs)
- Aged 60 to 99 years
- Clinical Frailty Scale (CFS) score of 3 to 5
- Identified by the active aging centre as inactive in centre and community activities
- Able to provide valid informed consent
- Able to communicate in and read Chinese or English
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- Living in their own homes and not in residential care
- Willing to allow home visits by the research team
- Residing in a home environment assessed as safe for exercise (e.g., adequate space and minimal environmental fall hazards)
- Spouse, partner, child, relative, friend, or neighbor of the participant who provides unpaid support
- Living with the participant or living separately
- Aged 21 to 99 years
- Able to communicate in and read English or Chinese
- Living with the participant or willing to visit the participant two to three times per week to support the intervention
- Cognitively fit as indicated by a Montreal Cognitive Assessment (MoCA) score above the normal cutoff
- Assessed by the research team to be suitable for delivering the intervention
Who cannot join
- Significant cognitive impairment or mental health conditions that prevent understanding of the study or safe participation in the exergaming activity (e.g., moderate to severe Alzheimer's disease)
- Pre-existing medical conditions that prohibit exercise or are hemodynamically unstable (e.g., end-stage heart failure)
- Physical limitations that hinder participation (e.g., wheelchair-bound)
- Severe visual or hearing impairments that would interfere with participation
- Experiencing severe pain that limits participation
- Currently participating in another regular vigorous exercise program
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- Refusal to consent to video recording required for the exergaming system
- For Informal Caregiver
- Paid caregivers, such as healthcare professionals or foreign domestic helpers.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jie Dong contact
Singapore2 sites
Lions Befrienders Active Ageing Center
Singapore
Dan Chong Chee Ng, 1800 375 8600, dan.ng@lb.org.sg
Tzu Chi Senior Activity Centre
Singapore
Weng Foo Lee, (65) 6355 9066, wengfoo.lee@tzuchi.org.sg
About this study
Official title: The Development and Feasibility Testing of a Caregiver-mediated, Technology-facilitated, Home-based Frail Intervention Program (FITWISE) for Pre-frail and Frail Community-dwelling Older Adults: a Three-arm Pilot Randomized Controlled Trial
The goal of this pilot trial is to evaluate the feasibility and potential effectiveness of a caregiver-mediated, technology-facilitated home-based intervention named Frailty Improvement through Technology With Informal Caregiver Supported Exercise (FITWISE) for pre-frail and frail community-dwelling older adults aged 60 years and older.
Frailty is associated with reduced physical function, increased risk of falls, and higher healthcare utilization among older adults. Home-based interventions supported by informal caregivers and facilitated by digital technology may help improve exercise participation and health outcomes in this population.
Read more
The main questions this study aims to answer are:
- Whether the FITWISE intervention is feasible in terms of recruitment, participant engagement, adherence, retention, and safety.
- Whether the FITWISE intervention improves physical performance and other health-related outcomes among pre-frail and frail community-dwelling older adults.
Researchers will compare two intervention groups with a control group to determine whether the FITWISE intervention improves health outcomes.
Participants will be randomly assigned to one of three groups:
- Intervention Group A: Caregiver-mediated multi-component exercise supported by an exergaming system.
- Intervention Group B: The same exercise program with additional caregiver-delivered psychosocial support.
- Control Group: General health education and usual activities without the FITWISE intervention.
The intervention will last 24 weeks and will include an active 12-week intervention phase followed by a 12-week maintenance phase. Outcome measures such as physical performance, frailty status, cognitive function, social support, quality of life, and selected health indicators will be assessed at baseline and after the intervention.
Read the detailed description
- Frailty is a multidimensional geriatric syndrome characterized by decreased physiological reserve and increased vulnerability to adverse health outcomes such as falls, disability, hospitalization, and mortality. As populations age globally, frailty has become a significant public health concern. Exercise interventions have been shown to improve physical function and delay frailty progression among older adults. However, many community-dwelling older adults face barriers to participating in structured exercise programs, including limited access to rehabilitation services, transportation difficulties, and lack of sustained motivation.
- Caregiver-mediated interventions and digital health technologies may help address these barriers by enabling home-based exercise and ongoing support. Informal caregivers often play an important role in supporting older adults in maintaining a healthy lifestyle. Integrating caregiver support with technology-assisted exercise programs may therefore improve frail older adults' physical function, enhance program adherence, and improve the sustainability of frailty interventions.
- The Frailty Improvement through Technology With Informal Caregiver Supported Exercise (FITWISE) program is a caregiver-mediated, technology-facilitated home-based intervention designed for pre-frail and frail community-dwelling older adults. The intervention integrates a multi-component exercise program with an artificial intelligence-assisted exergaming system and caregiver-based psychosocial support strategies.
- The study will be conducted in two phases. Phase 1 involves the development and field testing of the FITWISE intervention. During this phase, the research team will develop the exercise protocol, caregiver training materials, and exergaming system in collaboration with clinicians, physiotherapists, and community partners. Field testing will be conducted to assess the usability, feasibility, and technical performance of the intervention components before the trial phase.
- Phase 2 will consist of a stratified three-arm pilot randomized controlled trial involving older adult-caregiver dyads recruited from community organizations in Singapore. Participants will be randomly assigned to one of three study groups: (1) FITWISE multicomponent exercise supported by an exergaming system, (2) FITWISE multicomponent exercise combined with caregiver-delivered psychosocial support, or (3) a control group receiving general health education and usual activities.
- The FITWISE intervention will last for 24 weeks and will consist of a 12-week active intervention phase followed by a 12-week maintenance phase. During the intervention phase, participants will perform multicomponent exercises including strength and balance training using an exergaming platform that provides real-time feedback on body movements. Caregivers will assist participants in performing exercises at home and provide support. In the Intervention Group B (psychosocial support group), caregivers will receive additional training on communication strategies and behavior change techniques to support sustained participation in physical activity.
- Home visits by trained research personnel will be conducted to supervise exercise sessions, adjust exercise difficulty levels via artificial intelligence, provide guidance to caregivers, and monitor participant safety. Participants will also be encouraged to practice exercises independently during non-home visit periods. The exergaming system uses motion capture through a webcam to detect body movements and provide immediate feedback on exercise performance while ensuring that no identifiable images are recorded.
- This pilot trial will evaluate the feasibility of implementing the FITWISE intervention in a community setting and explore its potential effectiveness in improving physical performance and health-related outcomes among pre-frail and frail community-dwelling older adults. Findings from this study will inform the refinement of the intervention and guide the design of future larger-scale randomized controlled trials aimed at improving frailty management in aging populations.
- Conditions
- Frailty, Pre-Frailty
- Being tested
- FITWISE, Psychosocial support, Health education control
- Keywords
- Frailty, Pre-frailty, Older adults, Caregiver-mediated exercise interventions, Home-based exercise, Artificial intelligence, Exergame, Multicomponent exercise, Community-dwelling older adults, Digital health intervention
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FITWISEBehavioural
- The intervention will last 24 weeks, consisting of a 12-week active phase followed by a 12-week maintenance phase. During the first 12 weeks, participants will perform a caregiver-mediated multicomponent exercise program supported by an exergaming system at home. A research team member will conduct home visits every two weeks during the active phase.
- During these visits, the research staff will facilitate the exergaming sessions and coach caregivers on how to safely assist older adults in performing the exercises. Exercise difficulty will be progressively increased every two weeks according to the exercise protocol.
- For the following 12-week maintenance phase, participants will be encouraged to continue their individualized exercise regimen at home. During this phase, the research team member will conduct monthly home visits to assess progress and provide guidance based on the exercise protocol. Each home visit during the maintenance phase will last about 60-90 minutes
Psychosocial supportBehavioural
- Caregivers will receive training on how to provide psychosocial support and facilitate behavioral change in participants. The training will be conducted by the RA and/or principal investigator over two half-day workshops, each lasting approximately four hours. The workshops will be delivered either via Zoom or face-to-face.
- The first workshop will cover educational topics including aging, body changes, frailty, and the importance of health enhancing physical activity. The second workshop will focus on effective communication, dyadic relationships, coping strategies, and behavioral modification techniques. All learning materials will be compiled into the FITWISE caregiver guide, which will be provided to caregivers for future reference.
Health education controlBehavioural
Participants in the control group will maintain their regular lifestyle and daily activities. If they engage in additional physical activities, they will be asked to record details such as duration, frequency, type, and intensity. During the intervention phase, the research personnel will conduct bi-weekly home visits to provide general health education, covering topics like healthy eating, frailty, exercise types, and health-promoting behaviours.
| Study group | Role | What they receive |
|---|---|---|
| FITWISE | Experimental | The eligible older adult-caregiver dyads will undergo a 24-week intervention consisting of a multicomponent exercise regimen with exergaming Receives: Behavioral: FITWISE |
| FITWISE with caregiver psychosocial support | Experimental | - The eligible older adult-caregiver dyads will perform the same FITWISE intervention. In addition, caregivers will provide an extra psychosocial support component. Receives: Behavioral: FITWISE; Behavioral: Psychosocial support |
| Health education control | Active comparator | The participant will receive general health education and continue their usual activities without participating in the FITWISE exercise program. Receives: Behavioral: Health education control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility Rate
The percentage of screened individuals who meet all inclusion criteria and none of the exclusion criteria. This is calculated as (Number of eligible participants / Total number of individuals screened) × 100.
Measured: From the start of recruitment until the final sample size is reached and recruitment concludes, up to 1 year.
Recruitment Rate
The percentage of eligible individuals who provide informed consent and are randomized into the study. This is calculated as (Number of randomized participants / Total number of eligible participants) × 100.
Measured: From the start of recruitment until the final sample size is reached, and recruitment concludes, up to 1 year.
Recruitment Duration
The total number of weeks required to reach the target sample size of 60 older adult-caregiver dyads.
Measured: From the date of the first participant screening until the target sample size is achieved, up to 1 year
Average Weekly Exercise Frequency
The mean number of exercise sessions performed per week per participant.
Measured: Up to 6 months
Exercise Adherence Rate
The percentage of prescribed exercise sessions successfully completed by participants during the 24-week intervention period. This is calculated as (number of completed sessions / total number of prescribed sessions) × 100.
Measured: Through study completion, an average of 6 months
Participant Completion Rate
The percentage of randomized participants who complete the full 24-week study protocol. This is calculated as (Number of participants who completed the 24-week study protocol / Total number of randomized participants) × 100.
Measured: Up to 6 months
Participant Dropout Rate
The percentage of participants who withdraw or are lost to follow-up before the 24-week mark. This is calculated as (Number of participants who withdrew or were lost to follow-up / Total number of randomized participants) × 100.
Measured: Up to 6 months
Incidence of Intervention-Related Adverse Events
Intervention-related adverse events will be recorded throughout the study period, including exercise-related injuries or events leading to early termination of participation.
Measured: Through study completion, an average of 6 months
Handgrip Strength
Handgrip strength will be measured using a handheld dynamometer following standardized procedures. Participants will perform maximal grip contractions while seated with the elbow flexed at 90 degrees. Three trials will be conducted for each hand, and the highest value recorded will be used for analysis. Results will be expressed in kilograms as an indicator of upper limb muscle strength.
Measured: Baseline
Handgrip Strength
Handgrip strength will be measured using a handheld dynamometer following standardized procedures. Participants will perform maximal grip contractions while seated with the elbow flexed at 90 degrees. Three trials will be conducted for each hand, and the highest value recorded will be used for analysis. Results will be expressed in kilograms as an indicator of upper limb muscle strength.
Measured: 6 months from baseline
Functional Reach Test
Participants will stand upright next to a wall and extend one arm forward at shoulder height. They will be instructed to reach forward as far as possible without stepping or losing balance. The distance reached from the starting position to the maximal forward reach will be measured in centimeters, with greater distances indicating better balance and postural stability.
Measured: Baseline
Functional Reach Test
Participants will stand upright next to a wall and extend one arm forward at shoulder height. They will be instructed to reach forward as far as possible without stepping or losing balance. The distance reached from the starting position to the maximal forward reach will be measured in centimeters, with greater distances indicating better balance and postural stability.
Measured: 6 months from baseline
Timed Up and Go
Participants will be instructed to stand up from a seated position in a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The total time taken to complete the task will be recorded in seconds, with shorter times indicating better mobility.
Measured: Baseline
Timed Up and Go
Participants will be instructed to stand up from a seated position in a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The total time taken to complete the task will be recorded in seconds, with shorter times indicating better mobility.
Measured: 6 months from baseline
Five Times Sit to Stand
Participants will be instructed to stand up and sit down five times as quickly as possible from a standard chair without using their arms. The total time taken to complete five repetitions will be recorded in seconds, with shorter times indicating better lower extremity strength and functional performance.
Measured: Baseline
Five Times Sit to Stand
Participants will be instructed to stand up and sit down five times as quickly as possible from a standard chair without using their arms. The total time taken to complete five repetitions will be recorded in seconds, with shorter times indicating better lower extremity strength and functional performance.
Measured: 6 months from baseline
Secondary outcomes (18)
Frailty Status as Assessed by the Clinical Frailty Scale
Frailty status will be assessed using the Clinical Frailty Scale (CFS), a validated tool that evaluates an individual's level of frailty based on physical fitness, comorbidities, and functional ability. The scale ranges from 1 (very fit) to 9 (terminally ill), with higher scores indicating greater frailty severity.
Measured: Baseline
Frailty Status as Assessed by the Clinical Frailty Scale
Frailty status will be assessed using the Clinical Frailty Scale (CFS), a validated tool that evaluates an individual's level of frailty based on physical fitness, comorbidities, and functional ability. The scale ranges from 1 (very fit) to 9 (terminally ill), with higher scores indicating greater frailty severity.
Measured: 6 months from baseline
Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA evaluates eight cognitive domains including visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Total scores range from 0 to 30, with higher scores indicating better cognitive function.
Measured: Baseline
Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA evaluates eight cognitive domains including visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Total scores range from 0 to 30, with higher scores indicating better cognitive function.
Measured: 6 months from baseline
Perceived Social Support as Measured by the Lubben Social Network Scale-6
Perceived social support will be assessed using the Lubben Social Network Scale-6 (LSNS-6). The scale consists of six items evaluating the size, closeness, and frequency of contact with family and friends. Total scores range from 0 to 30, with higher scores indicating stronger social networks and greater perceived social support.
Measured: Baseline
Perceived Social Support as Measured by the Lubben Social Network Scale-6
Perceived social support will be assessed using the Lubben Social Network Scale-6 (LSNS-6). The scale consists of six items evaluating the size, closeness, and frequency of contact with family and friends. Total scores range from 0 to 30, with higher scores indicating stronger social networks and greater perceived social support.
Measured: 6 months from baseline
Quality of Life as Assessed by the European Quality of Life 5-Dimension Instrument
The EQ-5D evaluates five domains including mobility, self care, usual activities, pain or discomfort, and anxiety or depression. Responses will be converted into an index score according to standardized scoring procedures, with higher scores indicating better health related quality of life.
Measured: Baseline
Quality of Life as Assessed by the European Quality of Life 5-Dimension Instrument
The EQ-5D evaluates five domains including mobility, self care, usual activities, pain or discomfort, and anxiety or depression. Responses will be converted into an index score according to standardized scoring procedures, with higher scores indicating better health related quality of life.
Measured: 6 months from baseline
Unplanned Health Services Usage
Unplanned healthcare service use will be assessed through participant self-report ed healthcare utilization in the past six months. Participants will report the number of unplanned hospital admissions, accident and emergency (A\&E) visits, and unplanned medical consultations (e.g., general practitioner, polyclinic, or private clinic visits without a prior appointment). The frequency of each type of unplanned healthcare visit will be recorded.
Measured: Baseline
Unplanned Health Services Usage
Unplanned healthcare service use will be assessed through participant self-report ed healthcare utilization in the past six months. Participants will report the number of unplanned hospital admissions, accident and emergency (A\&E) visits, and unplanned medical consultations (e.g., general practitioner, polyclinic, or private clinic visits without a prior appointment). The frequency of each type of unplanned healthcare visit will be recorded.
Measured: 6 months from baseline
Body Weight
Body weight will be measured in kilograms (kg) using a calibrated digital weighing scale with participants wearing light clothing and no shoes.
Measured: Baseline
Body Weight
Body weight will be measured in kilograms (kg) using a calibrated digital weighing scale with participants wearing light clothing and no shoes.
Measured: 6 months from baseline
Resting Heart Rate
Resting heart rate will be measured in beats per minute (bpm) using an automated blood pressure monitor with heart rate detection after the participant has rested in a seated position for at least 5 minutes.
Measured: Baseline
Resting Heart Rate
Resting heart rate will be measured in beats per minute (bpm) using an automated blood pressure monitor with heart rate detection after the participant has rested in a seated position for at least 5 minutes.
Measured: 6 months from baseline
Blood Pressure
Blood pressure will be measured in millimeters of mercury (mmHg) using an automated blood pressure monitor after the participant has rested in a seated position for at least 5 minutes. Both systolic and diastolic blood pressure values will be recorded.
Measured: Baseline
Blood Pressure
Blood pressure will be measured in millimeters of mercury (mmHg) using an automated blood pressure monitor after the participant has rested in a seated position for at least 5 minutes. Both systolic and diastolic blood pressure values will be recorded.
Measured: 6 months from baseline
Height
Height will be measured in meters (m) using a wall-marking method with a tape measure, with participants standing upright, back against the wall, without shoes. The researcher will place a ruler on top of the participant's head, pressing down lightly to reach the wall, and mark the wall with a pencil. The distance from the floor to the pencil mark will be measured with a tape measure.
Measured: Baseline
Height
Height will be measured in meters (m) using a wall-marking method with a tape measure, with participants standing upright, back against the wall, without shoes. The researcher will place a ruler on top of the participant's head, pressing down lightly to reach the wall, and mark the wall with a pencil. The distance from the floor to the pencil mark will be measured with a tape measure.
Measured: 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Feb 2027 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies 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
- Participants will be randomly assigned in a 1:1:1 ratio to one of three study groups: (1) multicomponent exercise supported by an exergaming system, (2) the same exercise program with an additional caregiver-delivered psychosocial support, or (3) a control group receiving general health education. Participants will remain in their assigned group for the entire study duration.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Lions Befrienders Service Association (Singapore), National University Health System, Singapore, National University Polyclinics, Singapore, Tzu-Chi Foundation (Singapore)
- Responsible party
- Principal investigator, Jiang Ying, National University of Singapore
- Investigators
- Ying Jiang, Principal investigator, Alice Lee Center for Nursing Studies, National University of Sngapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519642
- Sponsor's protocol ID
- NUS-IRB-2025-581
- Other IDs
- MOH-CNIG25jan-0006
- Acronym
- FITWISE
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing research data unrelated to the current study requires IRB approval and will be based on participants' consent.
Publications
Jiang Y, Oide K, Chow YE, Chen C, Zhang M, Chua MCH, Yoong SQ. Effectiveness of an Artificial Intelligence-Infused SinDance Exergame for Enhancing Physical Functions and Well-Being in Older Adults: A Pilot Randomized Controlled Trial. J Am Med Dir Assoc. 2025 Aug;26(8):105701. doi: 10.1016/j.jamda.2025.105701. Epub 2025 Jun 13. No abstract available.
PubMed 40456279Jiang Y, Chow YE, Oide K, Chen C, Lee PY, Chua MCH, Yoong SQ. Crafting Community Well-Being: Development of an AI-Powered SinDance Exergame for Older Adults in Singapore-A Pilot Randomized Trial. J Am Med Dir Assoc. 2024 Aug;25(8):105043. doi: 10.1016/j.jamda.2024.105043. Epub 2024 Jun 1. No abstract available.
PubMed 38830599Choo WT, Jiang Y, Chan KGF, Ramachandran HJ, Teo JYC, Seah CWA, Wang W. Effectiveness of caregiver-mediated exercise interventions on activities of daily living, anxiety and depression post-stroke rehabilitation: A systematic review and meta-analysis. J Adv Nurs. 2022 Jul;78(7):1870-1882. doi: 10.1111/jan.15239. Epub 2022 Apr 22.
PubMed 35451521
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Feasibility Testing of a Caregiver-mediated, Technology-facilitated, Home-based Frail Intervention Program (FITWISE) for Pre-frail and Frail Community-dwelling Older Adults: a Three-arm Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07519642
- Acronym / sponsor ID
- FITWISE / NUS-IRB-2025-581
- Conditions
- Frailty, Pre-Frailty
- Keywords
- Frailty, Pre-frailty, Older adults, Caregiver-mediated exercise interventions, Home-based exercise, Artificial intelligence, Exergame, Multicomponent exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Lions Befrienders Service Association (Singapore), National University Health System, Singapore, National University Polyclinics, Singapore, Tzu-Chi Foundation (Singapore)
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 9 Apr 2026 (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 goal of this pilot trial is to evaluate the feasibility and potential effectiveness of a caregiver-mediated, technology-facilitated home-based intervention named Frailty Improvement through Technology With Informal Caregiver Supported Exercise (FITWISE) for pre-frail and frail community-dwelling older adults aged 60 years and older.
Frailty is associated with reduced physical function, increased risk of falls, and higher healthcare utilization among older adults. Home-based interventions supported by informal caregivers and facilitated by digital technology may help improve exercise participation and health outcomes in this population.
The main questions this study aims to answer are:
- Whether the FITWISE intervention is feasible in terms of recruitment, participant engagement, adherence, retention, and safety.
- Whether the FITWISE intervention improves physical performance and other health-related outcomes among pre-frail and frail community-dwelling older adults.
Researchers will compare two intervention groups with a control group to determine whether the FITWISE intervention improves health outcomes.
Participants will be randomly assigned to one of three groups:
- Intervention Group A: Caregiver-mediated multi-component exercise supported by an exergaming system.
- Intervention Group B: The same exercise program with additional caregiver-delivered psychosocial support.
- Control Group: General health education and usual activities without the FITWISE intervention.
The intervention will last 24 weeks and will include an active 12-week intervention phase followed by a 12-week maintenance phase. Outcome measures such as physical performance, frailty status, cognitive function, social support, quality of life, and selected health indicators will be assessed at baseline and after the intervention.
Detailed description
- Frailty is a multidimensional geriatric syndrome characterized by decreased physiological reserve and increased vulnerability to adverse health outcomes such as falls, disability, hospitalization, and mortality. As populations age globally, frailty has become a significant public health concern. Exercise interventions have been shown to improve physical function and delay frailty progression among older adults. However, many community-dwelling older adults face barriers to participating in structured exercise programs, including limited access to rehabilitation services, transportation difficulties, and lack of sustained motivation.
- Caregiver-mediated interventions and digital health technologies may help address these barriers by enabling home-based exercise and ongoing support. Informal caregivers often play an important role in supporting older adults in maintaining a healthy lifestyle. Integrating caregiver support with technology-assisted exercise programs may therefore improve frail older adults' physical function, enhance program adherence, and improve the sustainability of frailty interventions.
- The Frailty Improvement through Technology With Informal Caregiver Supported Exercise (FITWISE) program is a caregiver-mediated, technology-facilitated home-based intervention designed for pre-frail and frail community-dwelling older adults. The intervention integrates a multi-component exercise program with an artificial intelligence-assisted exergaming system and caregiver-based psychosocial support strategies.
- The study will be conducted in two phases. Phase 1 involves the development and field testing of the FITWISE intervention. During this phase, the research team will develop the exercise protocol, caregiver training materials, and exergaming system in collaboration with clinicians, physiotherapists, and community partners. Field testing will be conducted to assess the usability, feasibility, and technical performance of the intervention components before the trial phase.
- Phase 2 will consist of a stratified three-arm pilot randomized controlled trial involving older adult-caregiver dyads recruited from community organizations in Singapore. Participants will be randomly assigned to one of three study groups: (1) FITWISE multicomponent exercise supported by an exergaming system, (2) FITWISE multicomponent exercise combined with caregiver-delivered psychosocial support, or (3) a control group receiving general health education and usual activities.
- The FITWISE intervention will last for 24 weeks and will consist of a 12-week active intervention phase followed by a 12-week maintenance phase. During the intervention phase, participants will perform multicomponent exercises including strength and balance training using an exergaming platform that provides real-time feedback on body movements. Caregivers will assist participants in performing exercises at home and provide support. In the Intervention Group B (psychosocial support group), caregivers will receive additional training on communication strategies and behavior change techniques to support sustained participation in physical activity.
- Home visits by trained research personnel will be conducted to supervise exercise sessions, adjust exercise difficulty levels via artificial intelligence, provide guidance to caregivers, and monitor participant safety. Participants will also be encouraged to practice exercises independently during non-home visit periods. The exergaming system uses motion capture through a webcam to detect body movements and provide immediate feedback on exercise performance while ensuring that no identifiable images are recorded.
- This pilot trial will evaluate the feasibility of implementing the FITWISE intervention in a community setting and explore its potential effectiveness in improving physical performance and health-related outcomes among pre-frail and frail community-dwelling older adults. Findings from this study will inform the refinement of the intervention and guide the design of future larger-scale randomized controlled trials aimed at improving frailty management in aging populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three study groups: (1) multicomponent exercise supported by an exergaming system, (2) the same exercise program with an additional caregiver-delivered psychosocial support, or (3) a control group receiving general health education. Participants will remain in their assigned group for the entire study duration.
| Arm | Type | Receives |
|---|---|---|
| FITWISE | Experimental | Behavioral: FITWISEThe eligible older adult-caregiver dyads will undergo a 24-week intervention consisting of a multicomponent exercise regimen with exergaming |
| FITWISE with caregiver psychosocial support | Experimental | Behavioral: FITWISE, Behavioral: Psychosocial support- The eligible older adult-caregiver dyads will perform the same FITWISE intervention. In addition, caregivers will provide an extra psychosocial support component. |
| Health education control | Active comparator | Behavioral: Health education controlThe participant will receive general health education and continue their usual activities without participating in the FITWISE exercise program. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Spouse, partner, child, relative, friend, or neighbor of the participant who provides unpaid support
- Living with the participant or living separately
- Aged 21 to 99 years
- Able to communicate in and read English or Chinese
- Living with the participant or willing to visit the participant two to three times per week to support the intervention
Key exclusion criteria (9 listed)
- For Informal Caregiver
- Paid caregivers, such as healthcare professionals or foreign domestic helpers.
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 |
|---|---|---|
| FITWISE* The intervention will last 24 weeks, consisting of a 12-week active phase followed by a 12-week maintenance phase. During the first 12 weeks, participants will perform a caregiver-mediated multicomponent exercise program supported by an exergaming system at home. A research team member will conduct home visits every two weeks during the active phase. * During these visits, the research staff will facilitate the exergaming sessions and coach caregivers on how to safely assist older adults in performing the exercises. Exercise difficulty will be progressively increased every two weeks according to the exercise protocol. * For the following 12-week maintenance phase, participants will be encouraged to continue their individualized exercise regimen at home. During this phase, the research team member will conduct monthly home visits to assess progress and provide guidance based on the exercise protocol. Each home visit during the maintenance phase will last about 60-90 minutes | Behavioural | FITWISE, FITWISE with caregiver psychosocial support |
| Psychosocial support* Caregivers will receive training on how to provide psychosocial support and facilitate behavioral change in participants. The training will be conducted by the RA and/or principal investigator over two half-day workshops, each lasting approximately four hours. The workshops will be delivered either via Zoom or face-to-face. * The first workshop will cover educational topics including aging, body changes, frailty, and the importance of health enhancing physical activity. The second workshop will focus on effective communication, dyadic relationships, coping strategies, and behavioral modification techniques. All learning materials will be compiled into the FITWISE caregiver guide, which will be provided to caregivers for future reference. | Behavioural | FITWISE with caregiver psychosocial support |
| Health education controlParticipants in the control group will maintain their regular lifestyle and daily activities. If they engage in additional physical activities, they will be asked to record details such as duration, frequency, type, and intensity. During the intervention phase, the research personnel will conduct bi-weekly home visits to provide general health education, covering topics like healthy eating, frailty, exercise types, and health-promoting behaviours. | Behavioural | Health education control |
Primary outcome
Eligibility Rate
Time frame: From the start of recruitment until the final sample size is reached and recruitment concludes, up to 1 year.
The percentage of screened individuals who meet all inclusion criteria and none of the exclusion criteria. This is calculated as (Number of eligible participants / Total number of individuals screened) × 100.
Recruitment Rate
Time frame: From the start of recruitment until the final sample size is reached, and recruitment concludes, up to 1 year.
The percentage of eligible individuals who provide informed consent and are randomized into the study. This is calculated as (Number of randomized participants / Total number of eligible participants) × 100.
Recruitment Duration
Time frame: From the date of the first participant screening until the target sample size is achieved, up to 1 year
The total number of weeks required to reach the target sample size of 60 older adult-caregiver dyads.
Average Weekly Exercise Frequency
Time frame: Up to 6 months
The mean number of exercise sessions performed per week per participant.
Exercise Adherence Rate
Time frame: Through study completion, an average of 6 months
The percentage of prescribed exercise sessions successfully completed by participants during the 24-week intervention period. This is calculated as (number of completed sessions / total number of prescribed sessions) × 100.
Participant Completion Rate
Time frame: Up to 6 months
The percentage of randomized participants who complete the full 24-week study protocol. This is calculated as (Number of participants who completed the 24-week study protocol / Total number of randomized participants) × 100.
Participant Dropout Rate
Time frame: Up to 6 months
The percentage of participants who withdraw or are lost to follow-up before the 24-week mark. This is calculated as (Number of participants who withdrew or were lost to follow-up / Total number of randomized participants) × 100.
Incidence of Intervention-Related Adverse Events
Time frame: Through study completion, an average of 6 months
Intervention-related adverse events will be recorded throughout the study period, including exercise-related injuries or events leading to early termination of participation.
Handgrip Strength
Time frame: Baseline
Handgrip strength will be measured using a handheld dynamometer following standardized procedures. Participants will perform maximal grip contractions while seated with the elbow flexed at 90 degrees. Three trials will be conducted for each hand, and the highest value recorded will be used for analysis. Results will be expressed in kilograms as an indicator of upper limb muscle strength.
Handgrip Strength
Time frame: 6 months from baseline
Handgrip strength will be measured using a handheld dynamometer following standardized procedures. Participants will perform maximal grip contractions while seated with the elbow flexed at 90 degrees. Three trials will be conducted for each hand, and the highest value recorded will be used for analysis. Results will be expressed in kilograms as an indicator of upper limb muscle strength.
Functional Reach Test
Time frame: Baseline
Participants will stand upright next to a wall and extend one arm forward at shoulder height. They will be instructed to reach forward as far as possible without stepping or losing balance. The distance reached from the starting position to the maximal forward reach will be measured in centimeters, with greater distances indicating better balance and postural stability.
Functional Reach Test
Time frame: 6 months from baseline
Participants will stand upright next to a wall and extend one arm forward at shoulder height. They will be instructed to reach forward as far as possible without stepping or losing balance. The distance reached from the starting position to the maximal forward reach will be measured in centimeters, with greater distances indicating better balance and postural stability.
Timed Up and Go
Time frame: Baseline
Participants will be instructed to stand up from a seated position in a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The total time taken to complete the task will be recorded in seconds, with shorter times indicating better mobility.
Timed Up and Go
Time frame: 6 months from baseline
Participants will be instructed to stand up from a seated position in a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The total time taken to complete the task will be recorded in seconds, with shorter times indicating better mobility.
Five Times Sit to Stand
Time frame: Baseline
Participants will be instructed to stand up and sit down five times as quickly as possible from a standard chair without using their arms. The total time taken to complete five repetitions will be recorded in seconds, with shorter times indicating better lower extremity strength and functional performance.
Five Times Sit to Stand
Time frame: 6 months from baseline
Participants will be instructed to stand up and sit down five times as quickly as possible from a standard chair without using their arms. The total time taken to complete five repetitions will be recorded in seconds, with shorter times indicating better lower extremity strength and functional performance.
18 secondary outcomes
Frailty Status as Assessed by the Clinical Frailty Scale
Time frame: Baseline
Frailty Status as Assessed by the Clinical Frailty Scale
Time frame: 6 months from baseline
Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline
Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)
Time frame: 6 months from baseline
Perceived Social Support as Measured by the Lubben Social Network Scale-6
Time frame: Baseline
Perceived Social Support as Measured by the Lubben Social Network Scale-6
Time frame: 6 months from baseline
Quality of Life as Assessed by the European Quality of Life 5-Dimension Instrument
Time frame: Baseline
Quality of Life as Assessed by the European Quality of Life 5-Dimension Instrument
Time frame: 6 months from baseline
Unplanned Health Services Usage
Time frame: Baseline
Unplanned Health Services Usage
Time frame: 6 months from baseline
Body Weight
Time frame: Baseline
Body Weight
Time frame: 6 months from baseline
Resting Heart Rate
Time frame: Baseline
Resting Heart Rate
Time frame: 6 months from baseline
Blood Pressure
Time frame: Baseline
Blood Pressure
Time frame: 6 months from baseline
Height
Time frame: Baseline
Height
Time frame: 6 months from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 40456279Jiang Y, Oide K, Chow YE, Chen C, Zhang M, Chua MCH, Yoong SQ. Effectiveness of an Artificial Intelligence-Infused SinDance Exergame for Enhancing Physical Functions and Well-Being in Older Adults: A Pilot Randomized Controlled Trial. J Am Med Dir Assoc. 2025 Aug;26(8):105701. doi: 10.1016/j.jamda.2025.105701. Epub 2025 Jun 13. No abstract available.
- Background: PubMed 38830599Jiang Y, Chow YE, Oide K, Chen C, Lee PY, Chua MCH, Yoong SQ. Crafting Community Well-Being: Development of an AI-Powered SinDance Exergame for Older Adults in Singapore-A Pilot Randomized Trial. J Am Med Dir Assoc. 2024 Aug;25(8):105043. doi: 10.1016/j.jamda.2024.105043. Epub 2024 Jun 1. No abstract available.
- Background: PubMed 35451521Choo WT, Jiang Y, Chan KGF, Ramachandran HJ, Teo JYC, Seah CWA, Wang W. Effectiveness of caregiver-mediated exercise interventions on activities of daily living, anxiety and depression post-stroke rehabilitation: A systematic review and meta-analysis. J Adv Nurs. 2022 Jul;78(7):1870-1882. doi: 10.1111/jan.15239. Epub 2022 Apr 22.
- Individual participant dataSharing planned: Undecided. Sharing research data unrelated to the current study requires IRB approval and will be based on participants' consent.
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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.
Jie Dong contact
Ying Jiang principal investigator
Alice Lee Center for Nursing Studies, National University of Sngapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FITWISE and Psychosocial support in people with Frailty and Pre-Frailty, run by National University of Singapore at 2 sites 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 16 inclusion and 9 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: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Jiang (+6565167791, nurjiy@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility Rate (time frame: From the start of recruitment until the final sample size is reached and recruitment concludes, up to 1 year.). The study lists 16 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 NCT07519642, which also lists 3 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 9 Apr 2026.