[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632896":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":38,"centralContacts":43,"locations":51,"responsibleParty":77,"collaborators":80,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":9,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":30,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":121,"whyStopped":30,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"National University of Singapore","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"FITWISE","EXPERIMENTAL","The eligible older adult-caregiver dyads will undergo a 24-week intervention consisting of a multicomponent exercise regimen with exergaming",[13],"Behavioral: FITWISE",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13,18],"Behavioral: Psychosocial support",{"label":20,"type":21,"description":22,"interventionNames":23},"Health education control","ACTIVE_COMPARATOR","The participant will receive general health education and continue their usual activities without participating in the FITWISE exercise program.",[24],"Behavioral: Health education control",[26,31,35],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"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.\n* 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.\n* 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",[9,15],null,{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"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\u002For principal investigator over two half-day workshops, each lasting approximately four hours. The workshops will be delivered either via Zoom or face-to-face.\n* 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.",[15],{"type":27,"name":20,"description":36,"armGroupLabels":37,"otherNames":30},"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.",[20],[39],{"name":40,"affiliation":41,"role":42},"Ying Jiang","Alice Lee Center for Nursing Studies, National University of Sngapore","PRINCIPAL_INVESTIGATOR",[44,48],{"name":40,"role":45,"phone":46,"phoneExt":30,"email":47},"CONTACT","+6565167791","nurjiy@nus.edu.sg",{"name":49,"role":45,"phone":30,"phoneExt":30,"email":50},"Jie Dong","djie@u.nus.edu",[52,67],{"facility":53,"status":30,"city":54,"state":30,"zip":30,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Lions Befrienders Active Ageing Center","Singapore","SG",{"type":57,"coordinates":58},"Point",[59,60],103.85007,1.28967,{"lat":60,"lon":59},[63],{"name":64,"role":45,"phone":65,"phoneExt":30,"email":66},"Dan Chong Chee Ng","1800 375 8600","dan.ng@lb.org.sg",{"facility":68,"status":30,"city":54,"state":30,"zip":30,"country":54,"countryCode":55,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Tzu Chi Senior Activity Centre",{"type":57,"coordinates":70},[59,60],{"lat":60,"lon":59},[73],{"name":74,"role":45,"phone":75,"phoneExt":30,"email":76},"Weng Foo Lee","(65) 6355 9066","wengfoo.lee@tzuchi.org.sg",{"type":42,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Jiang Ying","Assistant Professor",[81,84,86,88],{"name":82,"class":83},"Lions Befrienders Service Association (Singapore)","UNKNOWN",{"name":85,"class":6},"National University Health System, Singapore",{"name":87,"class":6},"National University Polyclinics, Singapore",{"name":89,"class":83},"Tzu-Chi Foundation (Singapore)","100632896","frailty-improvement-through-technology-with-informal-caregiver-supported-exercise-fitwise-for-pre-frail-and-frail-community-dwelling-older-adults-100632896",false,"NCT07519642","Frailty Improvement Through Technology With Informal Caregiver Supported Exercise (FITWISE) for Pre-frail and Frail Community-dwelling Older Adults","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","1. For Participants:\n\n   Inclusion Criteria:\n   * Recruited from Lions Befrienders Active Aging Centres (AACs) or Tzu Chi Active Aging Centres (AACs)\n   * Aged 60 to 99 years\n   * Clinical Frailty Scale (CFS) score of 3 to 5\n   * Identified by the active aging centre as inactive in centre and community activities\n   * Able to provide valid informed consent\n   * Able to communicate in and read Chinese or English\n   * Living in their own homes and not in residential care\n   * Willing to allow home visits by the research team\n   * Residing in a home environment assessed as safe for exercise (e.g., adequate space and minimal environmental fall hazards)\n\n   Exclusion Criteria:\n   * 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)\n   * Pre-existing medical conditions that prohibit exercise or are hemodynamically unstable (e.g., end-stage heart failure)\n   * Physical limitations that hinder participation (e.g., wheelchair-bound)\n   * Severe visual or hearing impairments that would interfere with participation\n   * Experiencing severe pain that limits participation\n   * Currently participating in another regular vigorous exercise program\n   * Refusal to consent to video recording required for the exergaming system\n2. For Informal Caregiver\n\nInclusion Criteria:\n\n* Spouse, partner, child, relative, friend, or neighbor of the participant who provides unpaid support\n* Living with the participant or living separately\n* Aged 21 to 99 years\n* Able to communicate in and read English or Chinese\n* Living with the participant or willing to visit the participant two to three times per week to support the intervention\n* Cognitively fit as indicated by a Montreal Cognitive Assessment (MoCA) score above the normal cutoff\n* Assessed by the research team to be suitable for delivering the intervention\n\nExclusion Criteria:\n\n\\- Paid caregivers, such as healthcare professionals or foreign domestic helpers.",true,"ALL","21 Years","99 Years",{"count":102,"type":103},60,"ESTIMATED","INTERVENTIONAL",[106],"NA","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.\n\nFrailty 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.\n\nThe main questions this study aims to answer are:\n\n1. Whether the FITWISE intervention is feasible in terms of recruitment, participant engagement, adherence, retention, and safety.\n2. Whether the FITWISE intervention improves physical performance and other health-related outcomes among pre-frail and frail community-dwelling older adults.\n\nResearchers will compare two intervention groups with a control group to determine whether the FITWISE intervention improves health outcomes.\n\nParticipants will be randomly assigned to one of three groups:\n\n* Intervention Group A: Caregiver-mediated multi-component exercise supported by an exergaming system.\n* Intervention Group B: The same exercise program with additional caregiver-delivered psychosocial support.\n* Control Group: General health education and usual activities without the FITWISE intervention.\n\nThe 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.",[109,110],"Frailty","Pre-Frailty",[109,112,113,114,115,116,117,118,119,120],"Pre-frailty","Older adults","Caregiver-mediated exercise interventions","Home-based exercise","Artificial intelligence","Exergame","Multicomponent exercise","Community-dwelling older adults","Digital health intervention","NOT_YET_RECRUITING","2026-04-06",{"date":124,"type":125},"2026-04-09","ACTUAL",{"date":127,"type":103},"2027-02-01",{"date":129,"type":103},"2028-06-30",{"name":5,"class":6},2]