Tele-rehabilitation Versus Center-based Rehabilitation in Patients With Heart Failure: a Pilot RCT
Tele-rehabilitation Versus Center-based Rehabilitation in Patients With Heart Failure: a Pilot RCT
This study is a single-center pilot randomized controlled trial designed to compare home-based cardiac rehabilitation delivered through the HERE solution with standard hospital-based cardiac rehabilitation in patients with clinically stable heart failure. Cardiac rehabilitation is recommended to improve functional capacity and clinical outcomes in this population; however, adherence to conventional center-based programs remains suboptimal.
The intervention consists of a structured rehabilitation program delivered over eight sessions, including aerobic and calisthenic exercises, supported by a tablet-based application with real-time monitoring and feedback. Participants in the control group receive the same rehabilitation program in a hospital setting under direct supervision.
The primary objective of the study is to evaluate the effectiveness of the intervention on functional capacity, measured using the 6-minute walk test. Secondary outcomes include adherence to the rehabilitation program, quality of life, exercise capacity parameters, vital signs, perceived exertion, and patient satisfaction.
This pilot study aims to assess the feasibility and preliminary effectiveness of a technology-supported home-based rehabilitation model to inform the design of future larger trials.
Inclusion Criteria:
- Age ≥18 years Diagnosis of clinically stable heart failure New York Heart Association (NYHA) class I-II Enrollment in a cardiac rehabilitation program Availability of a stable Wi-Fi connection and a smartphone at home Presence of a caregiver trained in the use of the study technology Ability and willingness to provide written informed consent
Exclusion Criteria: