Frailty, Pre-Frailty
Conditions
Keywords
Frailty, Pre-frailty, Older adults, Caregiver-mediated exercise interventions, Home-based exercise, Artificial intelligence, Exergame, Multicomponent exercise, Community-dwelling older adults, Digital health intervention
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.
Interventions
BEHAVIORALFITWISE
* 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
BEHAVIORALPsychosocial 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.
BEHAVIORALHealth 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.
Sponsors
National University of Singapore
Lions Befrienders Service Association (Singapore)
National University Health System, Singapore
National University Polyclinics, Singapore
Tzu-Chi Foundation (Singapore)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants will be randomly assigned in a 1:1:1 ratio to one of three study groups: (1) multicomponent exercise supported by an exergaming system, (2) the same exercise program with an additional caregiver-delivered psychosocial support, or (3) a control group receiving general health education. Participants will remain in their assigned group for the entire study duration.
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eligibility Rate | 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. |
| Recruitment Rate | 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. |
| Recruitment Duration | 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. |
| Average Weekly Exercise Frequency | Up to 6 months | The mean number of exercise sessions performed per week per participant. |
| Exercise Adherence Rate | 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. |
| Participant Completion Rate | 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. |
| Participant Dropout Rate | 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. |
| Incidence of Intervention-Related Adverse Events | 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. |
| Handgrip Strength | 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. |
| Functional Reach Test | 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. |
| Timed Up and Go | 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. |
| Five Times Sit to Stand | 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
| Measure | Time frame | Description |
|---|---|---|
| Frailty Status as Assessed by the Clinical Frailty Scale | 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. |
| Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA) | 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. |
| Perceived Social Support as Measured by the Lubben Social Network Scale-6 | 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. |
| Quality of Life as Assessed by the European Quality of Life 5-Dimension Instrument | 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. |
| Unplanned Health Services Usage | 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. |
| Body Weight | Baseline | Body weight will be measured in kilograms (kg) using a calibrated digital weighing scale with participants wearing light clothing and no shoes. |
| Resting Heart Rate | 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. |
| Blood Pressure | 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. |
| Height | 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. |
Countries
Singapore
Contacts
CONTACTYing Jiang
CONTACTJie Dong
PRINCIPAL_INVESTIGATORYing Jiang
Alice Lee Center for Nursing Studies, National University of Sngapore
Outcome results
None listed