{"type":"trials","record":{"id":35266,"source_id":"clinicaltrials-gov","external_id":"NCT03824106","title":"Frailty Rehabilitation","brief_summary":"Frailty is an important clinical state that contributes to falls, hospitalization, institutionalization and death. When an individual simultaneously has many health problems, a frailty \"tipping point\" may be triggered by even a minor stressful event such as adding a new drug or urinary tract infection. Our research suggests that approximately 23% of Canadians over age 65 are frail, and by age 85 this estimate increases to over 40%. As we learn more about frailty and its consequences, there is an urgent need to develop community-based interventions that will prevent or delay frailty in older adults. Our proposed study will examine if frailty rehabilitation program is an effective community-based intervention to promote healthy aging. The primary objective of our study is to determine if 4-month frailty rehabilitation improves physical function compared with control and exercise alone in community-dwelling older adults living with frailty and sarcopenia. Secondary objectives of our study are to determine if 4-months of frailty rehabilitation can improve functional abilities and reduce healthcare utilization during a 6-month follow-up period compared with control and exercise alone. Results will translate the first Canadian model of frailty and sarcopenia rehabilitation and management.","overall_status":"Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"McMaster University","enrollment":324,"countries":["Canada"],"start_date":"2022-09-02","completion_date":"2025-12-31","last_update_date":"2025-07-06","source_url":"https://clinicaltrials.gov/study/NCT03824106","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:20.087268+00:00","last_seen_at":"2026-09-25T06:10:25.747+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"65 Years","comparator":null,"organization":"McMaster University","interventions":["Control","Group Exercise","Nutrition and Medication review","Protein Supplement","Vitamin D"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change in Physical Performance — Baseline and 4-months","Change in Walking Speed — Baseline and 4-months","Change in Frailty — Baseline and 4-months","Change in Fear of Falling — Baseline and 4-months","Change in Balance Confidence — Baseline and 4-months","Change in Falls — Baseline and 4-months","Change in Fitness — Baseline and 4-months","Change in Strength — Baseline and 4-months","Change in Functional Mobility — Baseline and 4-months","Change in Cognition — Baseline and 4-months","Change in Health-related Quality of Life — Baseline and 4-months","Change in Life Space Mobility — Baseline and 4-months","Change in Basic Activities of Daily Living — Baseline and 4-months","Change in Instrumental Activities of Daily Living — Baseline and 4-months","Change in Depression / Mood — Baseline and 4-months","Change in Nutrition — Baseline and 4-months","Change in Sarcopenia — Baseline and 4-months","Change in Muscle Mass — Baseline and 4-months","Change in Emergency Room Visits — Baseline, 4-months and additional 6-month follow-up","Change in Hospitalizations — Baseline, 4-months and additional 6-month follow-up"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · QUADRUPLE","source_has_results":false},"controlled_terms":["Frailty","Control","Group Exercise","Nutrition and Medication review","Protein Supplement","Vitamin D"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:37.875473+00:00","duplicate_cluster_key":"id:nct03824106","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-09-02 to 2025-12-31","comparator":null,"confidence":"structured-source","population":"ALL · 65 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":"2026-09-25T06:10:25.819Z","intervention":["Control","Group Exercise","Nutrition and Medication review","Protein Supplement","Vitamin D"],"participants":324,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · QUADRUPLE","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":["Change in Physical Performance — Baseline and 4-months","Change in Walking Speed — Baseline and 4-months","Change in Frailty — Baseline and 4-months","Change in Fear of Falling — Baseline and 4-months","Change in Balance Confidence — Baseline and 4-months","Change in Falls — Baseline and 4-months","Change in Fitness — Baseline and 4-months","Change in Strength — Baseline and 4-months","Change in Functional Mobility — Baseline and 4-months","Change in Cognition — Baseline and 4-months","Change in Health-related Quality of Life — Baseline and 4-months","Change in Life Space Mobility — Baseline and 4-months","Change in Basic Activities of Daily Living — Baseline and 4-months","Change in Instrumental Activities of Daily Living — Baseline and 4-months","Change in Depression / Mood — Baseline and 4-months","Change in Nutrition — Baseline and 4-months","Change in Sarcopenia — Baseline and 4-months","Change in Muscle Mass — Baseline and 4-months","Change in Emergency Room Visits — Baseline, 4-months and additional 6-month follow-up","Change in Hospitalizations — Baseline, 4-months and additional 6-month follow-up"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"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/35266","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}