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ClinicalTrials.gov ID

NCT07519642

Lead Sponsor

National University of SingaporeOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

60Estimated

Last Update Posted

Apr 9, 2026Actual

Start Date

Feb 1, 2027Estimated

Primary Completion Date

Jun 30, 2028Estimated

Completion Date

Jun 30, 2028Estimated

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

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:

1. Whether the FITWISE intervention is feasible in terms of recruitment, participant engagement, adherence, retention, and safety.
2. 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.

• Frailty
• Pre-Frailty

• FITWISE
• Psychosocial support
• Health education control

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

1. For Participants:

   Inclusion Criteria:

   • 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)

   Exclusion Criteria:

   • 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

2. For Informal Caregiver

Inclusion Criteria:

• 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

Exclusion Criteria:

- Paid caregivers, such as healthcare professionals or foreign domestic helpers.

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

National University of SingaporeOTHER

Collaborators

Lions Befrienders Service Association (Singapore)UNKNOWN

National University Health System, SingaporeOTHER

National University Polyclinics, SingaporeOTHER

Tzu-Chi Foundation (Singapore)UNKNOWN

wengfoo.lee@tzuchi.org.sg(65) 6355 9066