Heart Failure NYHA Class III Clinical Trial
Official title:
Comprehensive Hybrid Cardiac Rehabilitation Trial to Assess Impact on Heart Failure Patients
CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone.
Comprehensive, hybrid cardiac rehabilitation (CR) models have been scantly investigated in heart failure (HF) populations, particularly in low-resource settings. 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. The experimental intervention will include evaluation, medical and nurse management, aerobic interval training, resistance exercise, psychosocial support, and education. These will initially be delivered in a center, transitioning to home in 4 stages. Participants in the control arm will receive face-to-face continuous aerobic exercise sessions and resistance exercises. The main outcomes are cardiorespiratory fitness, functional capacity, and quality of life. These will be measured at baseline, end of intervention, and 12-month follow-up. The pragmatic, comprehensive hybrid CR model could be implemented more broadly if superiority is demonstrated. ;
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