{"type":"trials","record":{"id":31349,"source_id":"clinicaltrials-gov","external_id":"NCT06036615","title":"The Effect of Exercise Training and Detraining on Frailty and Fall Risk in Patients With Chronic Heart Failure","brief_summary":"Chronic Heart Failure (CHF) is the endpoint for some cardiac and respiratory conditions as well as ageing affecting 1-2% of the global adult population. CHF requires a costly treatment, frequent hospitalizations due its severe complications leading CHF eventually to a frequent cause of morbidity and mortality worldwide. Another common complication of CHF is frailty. Frailty is a complex clinical syndrome associated with CHF, resulting from multiple organ impairment; physiological reserves decrease and vulnerability to stressors increase. Up to 79% of PwCHF are frail leading to reduced functional capacity, quality of life (QoL), and psychological well-being in CHF, and it is an independent predictor of mortality in cardiovascular disease. The role of cardiac rehabilitation (CR) programs for PwCHF in preventing frailty has recently draw the attention of the scientific world. Exercise constitutes a unique effective and feasible non-pharmacological treatment for frailty in CHF as it offers such benefits that are irreplaceable by medical treatment, with no side effects, and cost-effective treatment. However, there are no studies examining the effect of training and detraining on muscle strength and balance, fall prevention and fear of falling in PwCHF. The aim of this randomized controlled trial is to examine whether a 6-month combined aerobic, strengthening and flexibility-mobility CR program and a 3-month de-training period will affect frailty and fall risk in PwCHF. One hundred participants will be randomly allocated into two groups: Group A (Exercise Group) will receive 3 sessions per week for 6 months and Group B(Control Group) will continue their usual physical activity, without participating in organized exercise programs.After the intervention for Group A' will follow a 3- month de-training period and Group B' will continue their normal physical activity. Prior to the group random allocation, part of our assessments at baseline and after 6 (Evaluation A') and 10 months (Evaluation B'), will include demographics and clinical history, physical examination, ECG and echocardiogram, patients' ability to perform daily activities, functional tests, static balance tests, body composition analysis and 24-h heart rhythm holter monitoring. Moreover, we will use questionnaires assessing the QoL of people with CHF, depression, anxiety, sleep quality, cognitive function, fear of falling, physical activity, and sedentary behaviour.","overall_status":"Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Aristotle University Of Thessaloniki","enrollment":100,"countries":["Greece"],"start_date":"2023-10-01","completion_date":"2025-12-15","last_update_date":"2025-08-11","source_url":"https://clinicaltrials.gov/study/NCT06036615","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: 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":null,"age_range":"18 Years to 100 Years","comparator":"Group B","organization":"Aristotle University Of Thessaloniki","interventions":["Exercise Intervention"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Left Ventricular Systolic Function — Baseline","Left Ventricular Systolic Function — Evaluation A', 6- months","Left Ventricular Systolic Function — Evaluation B', 3 months after evaluation A'","Cardiac Autonomic Nervous System Function — Baseline","Cardiac Autonomic Nervous System Function — Evaluation A', 6- months","Cardiac Autonomic Nervous System Function — Evaluation B', 3 months","Body Composition Analysis — Baseline","Body Composition Analysis — Evaluation A', 3- months","Body Composition Analysis — Evaluation B', 3 months after evaluation A'","Six- Minute Walking Test — Baseline","Six- Minute Walking Test — Evaluation A', 6- months","Six- Minute Walking Test — Evaluation B', 3 months after evaluation A'","Timed- Up-and-Go Test — Baseline","Timed- Up-and-Go Test — Evaluation A', 6- months","Timed- Up-and-Go Test — Evaluation B', 3 months after evaluation A'","4m-Walking Test — Baseline","4m-Walking Test — Evaluation A', 6- months","4m-Walking Test — Evaluation B', 3 months after evaluation A'","30-second Sit-to-Stand (STS)Test — Baseline","30-second Sit-to-Stand (STS)Test — Evaluation A', 6- months"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","source_has_results":false},"controlled_terms":["Chronic Heart Failure","Exercise Intervention"],"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:nct06036615","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-10-01 to 2025-12-15","comparator":"Group B","confidence":"structured-source","population":"ALL · 18 Years to 100 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":"2026-09-25T06:10:07.494Z","intervention":["Exercise Intervention"],"participants":100,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","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":["Left Ventricular Systolic Function — Baseline","Left Ventricular Systolic Function — Evaluation A', 6- months","Left Ventricular Systolic Function — Evaluation B', 3 months after evaluation A'","Cardiac Autonomic Nervous System Function — Baseline","Cardiac Autonomic Nervous System Function — Evaluation A', 6- months","Cardiac Autonomic Nervous System Function — Evaluation B', 3 months","Body Composition Analysis — Baseline","Body Composition Analysis — Evaluation A', 3- months","Body Composition Analysis — Evaluation B', 3 months after evaluation A'","Six- Minute Walking Test — Baseline","Six- Minute Walking Test — Evaluation A', 6- months","Six- Minute Walking Test — Evaluation B', 3 months after evaluation A'","Timed- Up-and-Go Test — Baseline","Timed- Up-and-Go Test — Evaluation A', 6- months","Timed- Up-and-Go Test — Evaluation B', 3 months after evaluation A'","4m-Walking Test — Baseline","4m-Walking Test — Evaluation A', 6- months","4m-Walking Test — Evaluation B', 3 months after evaluation A'","30-second Sit-to-Stand (STS)Test — Baseline","30-second Sit-to-Stand (STS)Test — Evaluation A', 6- months"],"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.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","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/31349","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}