{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T15:51:28Z","timestamp":1753890688410,"version":"3.41.2"},"reference-count":68,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2024,11,14]],"date-time":"2024-11-14T00:00:00Z","timestamp":1731542400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Cardiovasc. Med."],"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Comprehensive, hybrid cardiac rehabilitation (CR) models have been scantly investigated in heart failure (HF) populations, particularly in low-resource settings. CO-CREATION-HF aims to evaluate the effectiveness of such a model compared to supervised exercise alone.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>A 2 parallel-arm, multi-center randomized clinical superiority trial will be conducted with blinded outcome assessment. 152 HF patients (NYHA class II or III) will be recruited consecutively, and randomly assigned using permuted blocks; allocation will be concealed. The 12-week intervention will include evaluation, medical and nurse management, aerobic interval training, resistance exercise training, psychosocial support, and education. These will initially be delivered in a center, transitioning to home in 4 stages. Controls will receive similar management, but face-to-face continuous aerobic exercise sessions and resistance exercises. The main outcomes are cardiorespiratory fitness (VO<jats:sub>2<\/jats:sub> max), functional capacity (m from 6\u2005MWT), and quality of life (Minnesota Living with Heart Failure Questionnaire). Program adherence and completion, NT-proBNP, functioning, all-cause and HF-specific mortality and hospitalization, muscle strength, adverse events and cost will be secondary outcomes. These will be measured at baseline, end of intervention, and 12-month follow-up. The sample size was calculated considering 90% power, a significance level of 5%, a between-group difference equivalent to 1\/2 MET, and a 10% potential loss to follow-up. Intention-to-treat analysis will be considered. Between-group differences will be assessed using Student's <jats:italic>t<\/jats:italic>-tests or <jats:italic>Z<\/jats:italic>-tests along with 95% confidence intervals, and the rate ratio will be computed to compare mortality.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>The study protocol and the Informed Consent form were approved by Ethical Committees at the Universidad de La Frontera (No. 081-23) and each center participating. Research findings will be disseminated to the scientific community and will be shared with relevant stakeholder groups and policy-makers. Finally, investigators shall reach HF patients via various dissemination channels such as social media.\n<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trial Registration<\/jats:title><jats:p><jats:uri>clinicaltrials.gov<\/jats:uri>, identifier (NCT06313684).<\/jats:p><\/jats:sec>","DOI":"10.3389\/fcvm.2024.1427544","type":"journal-article","created":{"date-parts":[[2024,11,14]],"date-time":"2024-11-14T06:21:57Z","timestamp":1731565317000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["CO-CREATION-HF protocol: clinical trial to evaluate the impact of a comprehensive and hybrid cardiac rehabilitation model on patients with heart 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