{"type":"trials","record":{"id":21936,"source_id":"clinicaltrials-gov","external_id":"NCT07205016","title":"FreeFrail Project: A Multicomponent Intervention for the Management of Frailty in Primary Care: A Randomized Controlled Trial","brief_summary":"The primary aim is to assess the effectiveness of a multicomponent intervention including dual-task exercise in improving functionality and cognitive performance and in reducing frailty among community-dwelling adults aged ≥65 years compared to usual care. Secondary objectives include evaluating its impact on pain, anxiety or depression, sleep quality, quality of life, physical activity, handgrip strength, and polypharmacy. A double-blind, randomized, parallel-group controlled trial will be conducted in primary care centers in Lleida. Frail older adults (≥65 years) will be recruited and randomly allocated to either the intervention group, receiving a structured cognitive-motor dual-task based multicomponent program, or the control group, receiving usual care. Outcomes will be assessed using validated tools at baseline and follow-up.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Universitat de Lleida","enrollment":220,"countries":[],"start_date":"2026-01-01","completion_date":"2026-10-01","last_update_date":"2025-10-03","source_url":"https://clinicaltrials.gov/study/NCT07205016","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":"2026-09-24T01:17:12.439005+00:00","last_seen_at":"2026-09-25T06:25:30.723+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"65 Years","comparator":"Control","organization":"Universitat de Lleida","interventions":["Dual task exercise","Otago exercise"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Physical performance and functional status — From enrollment to the end of treatment at 12 weeks","Cognitive function — From enrollment to the end of treatment at 12 weeks","Frailty status — From enrollment to the end of treatment at 12 weeks","Quality of life / Anxiety and Depression / Pain severity — From enrollment to the end of treatment at 12 weeks","Sleep performance — From enrollment to the end of treatment at 12 weeks","Physical activity — From enrollment to the end of treatment at 12 weeks","Handgrip strength — From enrollment to the end of treatment at 12 weeks","Inflammatory and mitochondrial function biomarkers — From enrollment to the end of treatment at 12 weeks"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","source_has_results":false},"controlled_terms":["Frail Elderly","Dual Task Exercises in Elderly People","Exercise Training","Frailty","Dual task exercise","Otago exercise"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:25:35.871646+00:00","duplicate_cluster_key":"id:nct07205016","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-01-01 to 2026-10-01","comparator":"Control","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":"2026-09-25T06:25:30.738Z","intervention":["Dual task exercise","Otago exercise"],"participants":220,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","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":["Physical performance and functional status — From enrollment to the end of treatment at 12 weeks","Cognitive function — From enrollment to the end of treatment at 12 weeks","Frailty status — From enrollment to the end of treatment at 12 weeks","Quality of life / Anxiety and Depression / Pain severity — From enrollment to the end of treatment at 12 weeks","Sleep performance — From enrollment to the end of treatment at 12 weeks","Physical activity — From enrollment to the end of treatment at 12 weeks","Handgrip strength — From enrollment to the end of treatment at 12 weeks","Inflammatory and mitochondrial function biomarkers — From enrollment to the end of treatment at 12 weeks"],"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/21936","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}