{"type":"trials","record":{"id":34923,"source_id":"clinicaltrials-gov","external_id":"NCT07519642","title":"Frailty Improvement Through Technology With Informal Caregiver Supported Exercise (FITWISE) for Pre-frail and Frail Community-dwelling Older Adults","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.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"National University of Singapore","enrollment":60,"countries":["Singapore"],"start_date":"2027-02-01","completion_date":"2028-06-30","last_update_date":"2026-04-09","source_url":"https://clinicaltrials.gov/study/NCT07519642","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:20.087268+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":"FITWISE","age_range":"21 Years to 99 Years","comparator":"Health education control","organization":"National University of Singapore","interventions":["FITWISE","Psychosocial support","Health education control"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Eligibility Rate — From the start of recruitment until the final sample size is reached and recruitment concludes, up t…","Recruitment Rate — From the start of recruitment until the final sample size is reached, and recruitment concludes, up…","Recruitment Duration — From the date of the first participant screening until the target sample size is achieved, up to…","Average Weekly Exercise Frequency — Up to 6 months","Exercise Adherence Rate — Through study completion, an average of 6 months","Participant Completion Rate — Up to 6 months","Participant Dropout Rate — Up to 6 months","Incidence of Intervention-Related Adverse Events — Through study completion, an average of 6 months","Handgrip Strength — Baseline","Handgrip Strength — 6 months from baseline","Functional Reach Test — Baseline","Functional Reach Test — 6 months from baseline","Timed Up and Go — Baseline","Timed Up and Go — 6 months from baseline","Five Times Sit to Stand — Baseline","Five Times Sit to Stand — 6 months from baseline","Frailty Status as Assessed by the Clinical Frailty Scale — Baseline","Frailty Status as Assessed by the Clinical Frailty Scale — 6 months from baseline","Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA) — Baseline","Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA) — 6 months from baseline"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · SINGLE","source_has_results":false},"controlled_terms":["Frailty","Pre-Frailty","FITWISE","Psychosocial support","Health education control"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: exercise.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct07519642","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2027-02-01 to 2028-06-30","comparator":"Health education control","confidence":"structured-source","population":"ALL · 21 Years to 99 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.447Z","intervention":["FITWISE","Psychosocial support","Health education control"],"participants":60,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · SINGLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Eligibility Rate — From the start of recruitment until the final sample size is reached and recruitment concludes, up t…","Recruitment Rate — From the start of recruitment until the final sample size is reached, and recruitment concludes, up…","Recruitment Duration — From the date of the first participant screening until the target sample size is achieved, up to…","Average Weekly Exercise Frequency — Up to 6 months","Exercise Adherence Rate — Through study completion, an average of 6 months","Participant Completion Rate — Up to 6 months","Participant Dropout Rate — Up to 6 months","Incidence of Intervention-Related Adverse Events — Through study completion, an average of 6 months","Handgrip Strength — Baseline","Handgrip Strength — 6 months from baseline","Functional Reach Test — Baseline","Functional Reach Test — 6 months from baseline","Timed Up and Go — Baseline","Timed Up and Go — 6 months from baseline","Five Times Sit to Stand — Baseline","Five Times Sit to Stand — 6 months from baseline","Frailty Status as Assessed by the Clinical Frailty Scale — Baseline","Frailty Status as Assessed by the Clinical Frailty Scale — 6 months from baseline","Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA) — Baseline","Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA) — 6 months from baseline"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"exercise","is_published":true,"match_reasons":["Title contains controlled term: exercise.","Abstract contains controlled term: exercise.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Exercise","slug":"exercise"}},{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Source terminology contains: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/34923","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}