{"type":"trials","record":{"id":31250,"source_id":"clinicaltrials-gov","external_id":"NCT06225271","title":"Effects of the Combined Intervention of Exercise, Fruit, and Vitamin Supplementation on Frailty in Older Adults","brief_summary":"The goal of this cohort-based cluster-randomized controlled trial is to investigate the effect of the combined intervention of exercise, fruit, and vitamin supplementation on frailty among older adults. Older individuals aged 65\\~80 years old with low physical activity levels and low fruit intake will be recruited. 14 clusters will be randomized into 2 arms with 1:1 ratio. Participants in the intervention arm will receive the combined intervention of physical activity, fruit, and vitamin supplementation 3 times a week for 2 months (the 1st and 6th months). They will also be given group interventions, such as self-management group activity or health education, at least once a week. Participants in the control arm will not receive any intervention.","overall_status":"Active Not Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Nanjing Medical University","enrollment":934,"countries":["China"],"start_date":"2024-03-08","completion_date":"2026-03-01","last_update_date":"2025-12-19","source_url":"https://clinicaltrials.gov/study/NCT06225271","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Active Not Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:21.317971+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":"EFVF","age_range":"65 Years to 80 Years","comparator":"Control group","organization":"Nanjing Medical University","interventions":["the combined intervention of exercise, fruit, and vitamin supplementation"],"registry_source":"ClinicalTrials.gov","outcome_measures":["The change in handgrip strength at 12 months from baseline. — Baseline and 12 months","The change in handgrip strength at 6 months from baseline. — Baseline and 6 months","The change in frailty index at 6 months and 12 months from baseline. — Baseline, 6 months, and 12 months","The change in the quantity and frequency of fruit intake at 12 months from baseline. — Baseline and 12 months","The change in physical activity volume and intensity at 12 months from baseline. — Baseline and 12 months","The incidence of a composite of all-cause death, cardiovascular and cerebrovascular diseases over 12 and 24 months. — 1…","The incidence of all-cause death over 12 and 24 months. — 12 months, and 24 months","The incidence of cardiovascular and cerebrovascular diseases over 12 and 24 months. — 12 months, and 24 months","The change in low-density lipoprotein cholesterol (LDL-C) at 12 months and 24 months from baseline. — Baseline, 12 mont…","The change in high density lipoprotein cholesterol (HDL-C) at 12 months and 24 months from baseline. — Baseline, 12 mon…","The change in total cholesterol (TC) at 12 months and 24 months from baseline. — Baseline, 12 months, and 24 months","The change in triglycerides (TG) at 12 months and 24 months from baseline. — Baseline, 12 months, and 24 months","The change in fasting blood glucose at 12 months and 24 months from baseline. — Baseline, 12 months, and 24 months","Incremental cost-effectiveness ratio (ICER) — Baseline and 12 months"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · NONE","source_has_results":false},"controlled_terms":["Frailty","the combined intervention of exercise, fruit, and vitamin supplementation"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"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:nct06225271","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2024-03-08 to 2026-03-01","comparator":"Control group","confidence":"structured-source","population":"ALL · 65 Years to 80 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":"2026-09-25T06:10:07.473Z","intervention":["the combined intervention of exercise, fruit, and vitamin supplementation"],"participants":934,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · NONE","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":["The change in handgrip strength at 12 months from baseline. — Baseline and 12 months","The change in handgrip strength at 6 months from baseline. — Baseline and 6 months","The change in frailty index at 6 months and 12 months from baseline. — Baseline, 6 months, and 12 months","The change in the quantity and frequency of fruit intake at 12 months from baseline. — Baseline and 12 months","The change in physical activity volume and intensity at 12 months from baseline. — Baseline and 12 months","The incidence of a composite of all-cause death, cardiovascular and cerebrovascular diseases over 12 and 24 months. — 1…","The incidence of all-cause death over 12 and 24 months. — 12 months, and 24 months","The incidence of cardiovascular and cerebrovascular diseases over 12 and 24 months. — 12 months, and 24 months","The change in low-density lipoprotein cholesterol (LDL-C) at 12 months and 24 months from baseline. — Baseline, 12 mont…","The change in high density lipoprotein cholesterol (HDL-C) at 12 months and 24 months from baseline. — Baseline, 12 mon…","The change in total cholesterol (TC) at 12 months and 24 months from baseline. — Baseline, 12 months, and 24 months","The change in triglycerides (TG) at 12 months and 24 months from baseline. — Baseline, 12 months, and 24 months","The change in fasting blood glucose at 12 months and 24 months from baseline. — Baseline, 12 months, and 24 months","Incremental cost-effectiveness ratio (ICER) — Baseline and 12 months"],"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, physical activity.","Source terminology contains: exercise.","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":"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/31250","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}