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.
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
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
Parallel
FITWISE
Behavioral* 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 support
Behavioral* 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 control
BehavioralParticipants 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 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.
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.
Recruitment Duration
The total number of weeks required to reach the target sample size of 60 older adult-caregiver dyads.
Average Weekly Exercise Frequency
The mean number of exercise sessions performed per week per participant.
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.
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.
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.
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.
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National University of Singapore
Lead sponsor
Lions Befrienders Service Association (Singapore)
Collaborator
National University Health System, Singapore
Collaborator
National University Polyclinics, Singapore
Collaborator
Tzu-Chi Foundation (Singapore)
Collaborator
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