Frailty Improvement Through Technology With Informal Caregiver Supported Exercise (FITWISE) for Pre-frail and Frail Community-dwelling Older Adults
FITWISE
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
2 other identifiers
interventional
60
1 country
2
Brief 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 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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2027
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2026
CompletedFirst Posted
Study publicly available on registry
April 9, 2026
CompletedStudy Start
First participant enrolled
February 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
Study Completion
Last participant's last visit for all outcomes
June 30, 2028
April 9, 2026
April 1, 2026
1.4 years
March 10, 2026
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (16)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
6 months from baseline
Secondary Outcomes (18)
Frailty Status as Assessed by the Clinical Frailty Scale
Baseline
Frailty Status as Assessed by the Clinical Frailty Scale
6 months from baseline
Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)
Baseline
Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)
6 months from baseline
Perceived Social Support as Measured by the Lubben Social Network Scale-6
Baseline
- +13 more secondary outcomes
Study Arms (3)
FITWISE
EXPERIMENTALThe 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\- 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 COMPARATORThe participant will receive general health education and continue their usual activities without participating in the FITWISE exercise program.
Interventions
* 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
* 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.
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.
Eligibility Criteria
You may qualify if:
- 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
- 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)
You may not qualify if:
- 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
- Refusal to consent to video recording required for the exergaming system
- For Informal Caregiver
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National University of Singaporelead
- Tzu-Chi Foundation (Singapore)collaborator
- Lions Befrienders Service Association (Singapore)collaborator
- National University Health System, Singaporecollaborator
- National University Polyclinics, Singaporecollaborator
Study Sites (2)
Lions Befrienders Active Ageing Center
Singapore, Singapore
Tzu Chi Senior Activity Centre
Singapore, Singapore
Related Publications (3)
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.
PMID: 40456279BACKGROUNDJiang 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.
PMID: 38830599BACKGROUNDChoo 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.
PMID: 35451521BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ying Jiang
Alice Lee Center for Nursing Studies, National University of Sngapore
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 10, 2026
First Posted
April 9, 2026
Study Start (Estimated)
February 1, 2027
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
April 9, 2026
Record last verified: 2026-04