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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty; Pre-Frailty
• Intervention / Treatment: Behavioral: FITWISE; Behavioral: Psychosocial support; Behavioral: Health education control

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying Jiang; Phone Number: +6565167791; Email: nurjiy@nus.edu.sg
• Study Contact Backup: Name: Jie Dong; Email: djie@u.nus.edu

Study Locations

• Singapore
  • Singapore, Singapore
    • Lions Befrienders Active Ageing Center
    • Contact: Dan Chong Chee Ng; Phone Number: 1800 375 8600; Email: dan.ng@lb.org.sg
  • Singapore, Singapore
    • Tzu Chi Senior Activity Centre
    • Contact: Weng Foo Lee; Phone Number: (65) 6355 9066; Email: wengfoo.lee@tzuchi.org.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FITWISE; The eligible older adult-caregiver dyads will undergo a 24-week intervention consisting of a multicomponent exercise regimen with exergaming	Behavioral: 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
Experimental: FITWISE with caregiver psychosocial support; - The eligible older adult-caregiver dyads will perform the same FITWISE intervention. In addition, caregivers will provide an extra psychosocial support component.	Behavioral: 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; Behavioral: 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.
Active Comparator: Health education control; The participant will receive general health education and continue their usual activities without participating in the FITWISE exercise program.	Behavioral: Health education control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	6 months from baseline

Collaborators and Investigators

• Sponsor: National University of Singapore
• Collaborators: National University Polyclinics, Singapore; National University Health System, Singapore; Lions Befrienders Service Association (Singapore); Tzu-Chi Foundation (Singapore)
• Investigators: Principal Investigator: Ying Jiang, Alice Lee Center for Nursing Studies, National University of Sngapore

Publications and helpful links

General 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.
• Jiang 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.
• Choo 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pre-frailty; Older adults; Artificial intelligence; Frailty; Exergame; Community-dwelling older adults; Home-based exercise; Multicomponent exercise; Digital health intervention; Caregiver-mediated exercise interventions
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Frailty; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Psychiatric Rehabilitation
• Other Study ID Numbers: NUS-IRB-2025-581; MOH-CNIG25jan-0006 (Other Grant/Funding Number: Singapore National Medical Research Council (NMRC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Sharing research data unrelated to the current study requires IRB approval and will be based on participants' consent.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No