{"type":"trials","record":{"id":34896,"source_id":"clinicaltrials-gov","external_id":"NCT07133581","title":"Design and Validation of FEXO: A Playful Exercise Program for Institutionalized Frail Older Adults","brief_summary":"This multicenter randomized controlled trial aims to evaluate the effectiveness of a playful multicomponent exercise intervention (FEXO - Fun Exercise for Older Adults) on intrinsic capacity, frailty, and functional health in institutionalized older adults aged over 75. The FEXO program combines aerobic, strength, balance, and flexibility training in a recreational format. Participants will be randomized to an experimental group (receiving the 14-week FEXO program) or a wait-list control group (continuing daily routines). After the first intervention phase, the control group will also complete the program. Primary outcomes include improvements in intrinsic capacity domains (cognition, locomotion, vitality, sensory, and psychological), frailty phenotype (Fried criteria), and physical function.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Cardenal Herrera University","enrollment":80,"countries":["Spain"],"start_date":"2025-09-04","completion_date":"2025-12-31","last_update_date":"2026-04-21","source_url":"https://clinicaltrials.gov/study/NCT07133581","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. 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":"FEXO-FRAIL","age_range":"75 Years","comparator":"Wait-List Control Group","organization":"Cardenal Herrera University","interventions":["FEXO (Fun Exercise for Older Adults)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Intrinsic Capacity (IC) — Before and inmediately after the intervention","Frailty (Fried's Phenotype) — Before and inmediately after the intervention","Short Physical Performance Battery (SPPB) — Before and inmediately after the intervention","Timed Up and Go Test (TUG) — Before and inmediately after the intervention","Grip Strength (JAMAR Dynamometer) — Before and inmediately after the intervention","10-Meter Walk Test (10-MWT) — Before and inmediately after the intervention","Mini-Mental State Examination (MMSE) — Before and inmediately after the intervention","Mini Nutritional Assessment (MNA) — Before and inmediately after the intervention","Geriatric Depression Scale (GDS) — Before and inmediately after the intervention","Berg Balance Scale (BBS) — Before and inmediately after the intervention","Barthel Index — Before and inmediately after the intervention","Cornell Scale for Depression in Dementia — Before and inmediately after the intervention","Self-reported Vision — Before and inmediately after the intervention","Self-reported Hearing — Before and inmediately after the intervention"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":false},"controlled_terms":["Frailty Syndrome","Sarcopenia","FEXO (Fun Exercise for Older Adults)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: exercise.","quality_checked_at":"2026-09-25T06:10:37.875473+00:00","duplicate_cluster_key":"id:nct07133581","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-09-04 to 2025-12-31","comparator":"Wait-List Control Group","confidence":"structured-source","population":"ALL · 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":"2026-09-25T06:10:25.786Z","intervention":["FEXO (Fun Exercise for Older Adults)"],"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":["Intrinsic Capacity (IC) — Before and inmediately after the intervention","Frailty (Fried's Phenotype) — Before and inmediately after the intervention","Short Physical Performance Battery (SPPB) — Before and inmediately after the intervention","Timed Up and Go Test (TUG) — Before and inmediately after the intervention","Grip Strength (JAMAR Dynamometer) — Before and inmediately after the intervention","10-Meter Walk Test (10-MWT) — Before and inmediately after the intervention","Mini-Mental State Examination (MMSE) — Before and inmediately after the intervention","Mini Nutritional Assessment (MNA) — Before and inmediately after the intervention","Geriatric Depression Scale (GDS) — Before and inmediately after the intervention","Berg Balance Scale (BBS) — Before and inmediately after the intervention","Barthel Index — Before and inmediately after the intervention","Cornell Scale for Depression in Dementia — Before and inmediately after the intervention","Self-reported Vision — Before and inmediately after the intervention","Self-reported Hearing — Before and inmediately after the intervention"],"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.","Source terminology contains: exercise.","Title supplies longevity context: frail, older adult.","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"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/34896","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}