{"type":"trials","record":{"id":35203,"source_id":"clinicaltrials-gov","external_id":"NCT07132632","title":"Effect of a Multicomponent Therapeutic Exercise Program in Primary Care on Frailty and Sarcopenia in Older Adults","brief_summary":"Background: Frailty and sarcopenia are common conditions in older adults that increase the risk of disability, dependence, and hospitalizations. Frailty is characterized by decreased physiological reserve and functional capacity, while sarcopenia refers to the loss of muscle mass, strength, and performance. Both conditions are prevalent among older adults and represent a growing public health challenge as the population ages. Objective: This study aims to evaluate the effectiveness of a multicomponent therapeutic exercise program in reducing frailty and improving clinical parameters related to sarcopenia in community-dwelling older adults aged 65 years or older who attend primary care centers. Study Design: This is a quasi-experimental, multicenter, single-group pre-post clinical trial. The study includes two phases: a control phase (pre-intervention observation) and an experimental phase (intervention). Each participant will act as their own control. Participants: 60 older adults aged 65 or older will be recruited from primary care centers in the Baix Llobregat region (Catalonia, Spain). Eligibility criteria include mild to moderate frailty (Clinical Frailty Scale 4-6), ability to walk independently (with or without a walking aid), cognitive ability to follow instructions (MMSE ≥ 20), and clinical stability. Exclusion criteria include severe frailty, major cognitive impairment, acute illness, or participation in another structured exercise program. Intervention: Participants will take part in a 12-week multicomponent exercise program including 8 supervised sessions at the primary care center and 4 home-based sessions. Each session will last 60 minutes and include strength training, balance exercises, aerobic activity, and flexibility. The program follows FITT-VP principles (frequency, intensity, time, type, volume, and progression). Home sessions will be supported with illustrated manuals and biweekly follow-up calls. Outcomes: The primary outcome is the change in frailty level measured by the Clinical Frailty Scale (CFS). Secondary outcomes include handgrip strength, SARC-F score, Short Physical Performance Battery (SPPB), 4-meter walk test, Timed Up and Go (TUG), muscle mass index, rectus femoris and vastus lateralis ultrasound, cognitive status (MMSE), nutritional status (MNA-SF), falls, and hospitalizations. Assessments will be conducted at baseline (month 0), after the control phase (month 3), and after the intervention (month 6). Significance: This study will provide evidence on the medium-term effectiveness of a short, structured, and feasible intervention implemented in real-life primary care settings. If effective, this program could be integrated into preventive strategies to reduce frailty and sarcopenia, promote autonomy, and improve the quality of life among older adults. Results will inform clinical guidelines and contribute to the development of scalable interventions for aging populations.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina","enrollment":60,"countries":[],"start_date":"2025-11-02","completion_date":"2026-12-31","last_update_date":"2025-08-27","source_url":"https://clinicaltrials.gov/study/NCT07132632","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":"2026-09-25T06:10:25.747+00:00","metadata":{"sex":"ALL","acronym":"FRACTEP-65","age_range":"65 Years","comparator":"Control Arm","organization":"Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina","interventions":["12-week multicomponent therapeutic exercise program including supervised and home-based sessions focused on strength, b…","Placebo Pre-Treat"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change from Baseline in Clinical Frailty Scale (CFS) Score at 6 Months — Baseline (Month 0) to Month 6","Baseline (Month 0) to Month 6 — Baseline (Month 0) to Month 6","Change from Baseline in Short Physical Performance Battery (SPPB) Score at 6 Months — Baseline (Month 0) to Month 6","Change from Baseline in Gait Speed (4-Meter Walk Test) at 6 Months — Baseline (Month 0) to Month 6","Change from Baseline in Timed Up and Go (TUG) Test Performance at 6 Months — Baseline (Month 0) to Month 6","Change from Baseline in Estimated Skeletal Muscle Mass Index at 6 Months — Baseline (Month 0) to Month 6","Change in Rectus Femoris and Vastus Lateralis Muscle Thickness at 6 Months — Baseline (Month 0) to Month 6","Change from Baseline in Mini Nutritional Assessment-Short Form (MNA-SF) Score at 6 Months — Baseline (Month 0) to Month…","Change from Baseline in Mini-Mental State Examination (MMSE) Score at 6 Months — Baseline (Month 0) to Month 6","Number of Participants with Hospital Admissions During the Study Period — Baseline (Month 0) to Month 6","Number of Participants Reporting Falls During the Study Period — Baseline (Month 0) to Month 6","Adherence to Home-Based Exercise Sessions (Self-Reported Completion Rate) — Over the 12-week intervention","Self-Reported Enjoyment of Physical Activity (Likert Scale) at 6 Months — At Month 6"],"design_description":"NON RANDOMIZED · CROSSOVER · TREATMENT · SINGLE","source_has_results":false},"controlled_terms":["Frailty","Sarcopenia","Aging","Exercises Therapy","12-week multicomponent therapeutic exercise program including supervised and home-based sessions focused on strength, b…","Placebo Pre-Treat"],"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:nct07132632","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-11-02 to 2026-12-31","comparator":"Control Arm","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":"2026-09-25T06:10:25.815Z","intervention":["12-week multicomponent therapeutic exercise program including supervised and home-based sessions focused on strength, b…","Placebo Pre-Treat"],"participants":60,"study_design":"NON RANDOMIZED · CROSSOVER · 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":["Change from Baseline in Clinical Frailty Scale (CFS) Score at 6 Months — Baseline (Month 0) to Month 6","Baseline (Month 0) to Month 6 — Baseline (Month 0) to Month 6","Change from Baseline in Short Physical Performance Battery (SPPB) Score at 6 Months — Baseline (Month 0) to Month 6","Change from Baseline in Gait Speed (4-Meter Walk Test) at 6 Months — Baseline (Month 0) to Month 6","Change from Baseline in Timed Up and Go (TUG) Test Performance at 6 Months — Baseline (Month 0) to Month 6","Change from Baseline in Estimated Skeletal Muscle Mass Index at 6 Months — Baseline (Month 0) to Month 6","Change in Rectus Femoris and Vastus Lateralis Muscle Thickness at 6 Months — Baseline (Month 0) to Month 6","Change from Baseline in Mini Nutritional Assessment-Short Form (MNA-SF) Score at 6 Months — Baseline (Month 0) to Month…","Change from Baseline in Mini-Mental State Examination (MMSE) Score at 6 Months — Baseline (Month 0) to Month 6","Number of Participants with Hospital Admissions During the Study Period — Baseline (Month 0) to Month 6","Number of Participants Reporting Falls During the Study Period — Baseline (Month 0) to Month 6","Adherence to Home-Based Exercise Sessions (Self-Reported Completion Rate) — Over the 12-week intervention","Self-Reported Enjoyment of Physical Activity (Likert Scale) at 6 Months — At Month 6"],"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"}},{"topic_slug":"sarcopenia","is_published":true,"match_reasons":["Title contains controlled term: sarcopenia.","Abstract contains controlled term: sarcopenia.","Source terminology contains: sarcopenia.","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":"Sarcopenia","slug":"sarcopenia"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/35203","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}