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
Trial ID: NCT07519642
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2027-02-01
Completion date: 2028-06-30
Sponsor: National University of Singapore
Collaborators: Lions Befrienders Service Association (Singapore); National University Health System, Singapore; National University Polyclinics, Singapore; Tzu-Chi Foundation (Singapore)
Conditions: Frailty; Pre-Frailty
Interventions: FITWISE; Psychosocial support; Health education control
Locations: Lions Befrienders Active Ageing Center; Tzu Chi Senior Activity Centre
Countries: Singapore; Singapore
Enrollment: 60
Age range: 21 Years - 99 Years
Sex: ALL

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.

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.

Outcomes:
Eligibility Rate; Recruitment Rate; Recruitment Duration; Average Weekly Exercise Frequency; Exercise Adherence Rate; Participant Completion Rate; Participant Dropout Rate; Incidence of Intervention-Related Adverse Events; Handgrip Strength; Handgrip Strength; Functional Reach Test; Functional Reach Test; Timed Up and Go; Timed Up and Go; Five Times Sit to Stand; Five Times Sit to Stand