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| ID | Type | Description | Link |
|---|---|---|---|
| MOH-CNIG25jan-0006 | Other Grant/Funding Number | Singapore National Medical Research Council (NMRC) |
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| Name | Class |
|---|---|
| Lions Befrienders Service Association (Singapore) | UNKNOWN |
| National University Health System, Singapore | OTHER |
| National University Polyclinics, Singapore | OTHER |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FITWISE | Experimental | The eligible older adult-caregiver dyads will undergo a 24-week intervention consisting of a multicomponent exercise regimen with exergaming |
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| FITWISE with caregiver psychosocial support | Experimental | - The eligible older adult-caregiver dyads will perform the same FITWISE intervention. In addition, caregivers will provide an extra psychosocial support component. |
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| Health education control | Active Comparator | The participant will receive general health education and continue their usual activities without participating in the FITWISE exercise program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FITWISE | Behavioral |
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| 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. |
| 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 |
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For Participants:
Inclusion Criteria:
Exclusion Criteria:
For Informal Caregiver
Inclusion Criteria:
Exclusion Criteria:
- Paid caregivers, such as healthcare professionals or foreign domestic helpers.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Jiang | Contact | +6565167791 | nurjiy@nus.edu.sg | |
| Jie Dong | Contact | djie@u.nus.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ying Jiang | Alice Lee Center for Nursing Studies, National University of Sngapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lions Befrienders Active Ageing Center | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40456279 | Background | 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. | |
| 38830599 |
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Sharing research data unrelated to the current study requires IRB approval and will be based on participants' consent.
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| Tzu-Chi Foundation (Singapore) |
| UNKNOWN |
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.
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| Psychosocial support | Behavioral |
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| 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. |
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| 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 |
| 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 |
| Tzu Chi Senior Activity Centre | Singapore | Singapore |
|
| 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. |
| 35451521 | Background | 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. |
| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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