{"type":"trials","record":{"id":35283,"source_id":"clinicaltrials-gov","external_id":"NCT07023328","title":"BalL Exercises tO Prevent FrAilty in OldeR ADults (LEOPARD)","brief_summary":"This study aims to examine the effects of a multi-component intervention incorporating Swiss ball exercises and nutritional counseling on reducing frailty in a sample of pre-frail older adults in primary care. It also aims to assess its effects on physical performance, functional status, and cognitive and well-being measures. Participants aged between 65 and 75 years will be randomly assigned to the intervention group and \"usual care\" group . Over a 3-month period, the multi-component intervention will consist of Swiss ball exercises and nutritional counseling, whereas the \"usual care\" group will get verbal general health counseling on healthy eating and physical activity recommendations. Outcome Assessors who are blinded to treatment allocation will evaluate primary and secondary outcomes at the end of the intervention (3 months), and after 6 months follow-up period.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"American University of Beirut Medical Center","enrollment":80,"countries":[],"start_date":"2025-07-01","completion_date":"2027-07-01","last_update_date":"2025-06-24","source_url":"https://clinicaltrials.gov/study/NCT07023328","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":"(LEOPARD)","age_range":"65 Years to 75 Years","comparator":"Usual Care Group","organization":"American University of Beirut Medical Center","interventions":["A structured ball exercise program"],"registry_source":"ClinicalTrials.gov","outcome_measures":["FRAIL scale — Measurements will be assessed at baseline (before randomization) after 3 months at the end of the interve…","Grip strength measurement — Measurements will be assessed at baseline (before randomization) after 3 months at the end…","The Five Times Sit to Stand Test (5TSTS) — Measurements will be assessed at baseline (before randomization) after 3 mon…","The 4-m gait speed (4MGS) — Measurements will be assessed at baseline (before randomization) after 3 months at the end…","The Timed Up and Go test (TUG) — Measurements will be assessed at baseline (before randomization) after 3 months at the…","Lawton's Instrumental Activities of Daily Living (IADL) Scale — Measurements will be assessed at baseline (before rando…","The Montreal Cognitive Assessment (MoCA) — Measurements will be assessed at baseline (before randomization) after 3 mon…","Patient Health Questionnaire-4' (PHQ-4) — Measurements will be assessed at baseline (before randomization) after 3 mont…","World Health Organization Well-Being Index (WHO-5) — Measurements will be assessed at baseline (before randomization) a…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":false},"controlled_terms":["Frailty","A structured ball exercise program"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct07023328","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-07-01 to 2027-07-01","comparator":"Usual Care Group","confidence":"structured-source","population":"ALL · 65 Years to 75 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":"2026-09-25T06:10:07.503Z","intervention":["A structured ball exercise program"],"participants":80,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · 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":["FRAIL scale — Measurements will be assessed at baseline (before randomization) after 3 months at the end of the interve…","Grip strength measurement — Measurements will be assessed at baseline (before randomization) after 3 months at the end…","The Five Times Sit to Stand Test (5TSTS) — Measurements will be assessed at baseline (before randomization) after 3 mon…","The 4-m gait speed (4MGS) — Measurements will be assessed at baseline (before randomization) after 3 months at the end…","The Timed Up and Go test (TUG) — Measurements will be assessed at baseline (before randomization) after 3 months at the…","Lawton's Instrumental Activities of Daily Living (IADL) Scale — Measurements will be assessed at baseline (before rando…","The Montreal Cognitive Assessment (MoCA) — Measurements will be assessed at baseline (before randomization) after 3 mon…","Patient Health Questionnaire-4' (PHQ-4) — Measurements will be assessed at baseline (before randomization) after 3 mont…","World Health Organization Well-Being Index (WHO-5) — Measurements will be assessed at baseline (before randomization) a…"],"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/35283","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}