Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07519642

Frailty Improvement Through Technology With Informal Caregiver Supported Exercise (FITWISE) for Pre-frail and Frail Community-dwelling Older Adults

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Frailty

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lions Befrienders Active Ageing Center, Singapore

Loading trial locations.

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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
  • 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.

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. Eligibility Rate

    Time frame: From the start of recruitment until the final sample size is reached and recruitment concludes, up to 1 year.

    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.

  2. Recruitment Rate

    Time frame: From the start of recruitment until the final sample size is reached, and recruitment concludes, up to 1 year.

    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.

  3. Recruitment Duration

    Time frame: From the date of the first participant screening until the target sample size is achieved, up to 1 year

    The total number of weeks required to reach the target sample size of 60 older adult-caregiver dyads.

  4. Average Weekly Exercise Frequency

    Time frame: Up to 6 months

    The mean number of exercise sessions performed per week per participant.

  5. Exercise Adherence Rate

    Time frame: Through study completion, an average of 6 months

    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.

  6. Participant Completion Rate

    Time frame: Up to 6 months

    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.

  7. Participant Dropout Rate

    Time frame: Up to 6 months

    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.

  8. Incidence of Intervention-Related Adverse Events

    Time frame: Through study completion, an average of 6 months

    Intervention-related adverse events will be recorded throughout the study period, including exercise-related injuries or events leading to early termination of participation.

  9. Handgrip Strength

    Time frame: Baseline

    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.

  10. Handgrip Strength

    Time frame: 6 months from baseline

    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.

  11. Functional Reach Test

    Time frame: Baseline

    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.

  12. Functional Reach Test

    Time frame: 6 months from baseline

    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.

  13. Timed Up and Go

    Time frame: Baseline

    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.

  14. Timed Up and Go

    Time frame: 6 months from baseline

    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.

  15. Five Times Sit to Stand

    Time frame: Baseline

    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.

  16. Five Times Sit to Stand

    Time frame: 6 months from baseline

    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.

Secondary outcomes

  1. Frailty Status as Assessed by the Clinical Frailty Scale

    Time frame: Baseline

    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.

  2. Frailty Status as Assessed by the Clinical Frailty Scale

    Time frame: 6 months from baseline

    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.

  3. Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline

    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.

  4. Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)

    Time frame: 6 months from baseline

    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.

  5. Perceived Social Support as Measured by the Lubben Social Network Scale-6

    Time frame: Baseline

    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. Perceived Social Support as Measured by the Lubben Social Network Scale-6

    Time frame: 6 months from baseline

    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.

  7. Quality of Life as Assessed by the European Quality of Life 5-Dimension Instrument

    Time frame: Baseline

    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.

  8. Quality of Life as Assessed by the European Quality of Life 5-Dimension Instrument

    Time frame: 6 months from baseline

    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.

  9. Unplanned Health Services Usage

    Time frame: Baseline

    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.

  10. Unplanned Health Services Usage

    Time frame: 6 months from baseline

    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.

  11. Body Weight

    Time frame: Baseline

    Body weight will be measured in kilograms (kg) using a calibrated digital weighing scale with participants wearing light clothing and no shoes.

  12. Body Weight

    Time frame: 6 months from baseline

    Body weight will be measured in kilograms (kg) using a calibrated digital weighing scale with participants wearing light clothing and no shoes.

  13. Resting Heart Rate

    Time frame: Baseline

    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.

  14. Resting Heart Rate

    Time frame: 6 months from baseline

    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.

  15. Blood Pressure

    Time frame: Baseline

    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.

  16. Blood Pressure

    Time frame: 6 months from baseline

    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.

  17. Height

    Time frame: Baseline

    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.

  18. Height

    Time frame: 6 months from baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Dong

CONTACT

[email protected]

Ying Jiang

CONTACT

[email protected]

+6565167791

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Collaborators

  • Lions Befrienders Service Association (Singapore)
  • National University Health System, Singapore
  • National University Polyclinics, Singapore
  • Tzu-Chi Foundation (Singapore)

Registry information

Official study 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

Acronym: FITWISE

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.