Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure

Not yet recruitingOBSERVATIONAL
Enrollment

205

Participants

Timeline

Start Date

July 31, 2025

Primary Completion Date

January 31, 2026

Study Completion Date

May 31, 2026

Conditions
Heart Failure
Interventions
BEHAVIORAL

TELEREHABILITATION-YES

This intervention consists of a structured 8-week cardiac rehabilitation program performed at the patient's home using a certified telemedicine platform. Sessions are delivered in synchronous mode with real-time supervision by a physiotherapist through secure video conferencing. Each session includes warm-up, endurance training, and cooldown exercises, with personalized intensity based on cardiopulmonary exercise testing. Patients are equipped with wearable medical devices for continuous monitoring of vital signs (ECG, heart rate, blood pressure, oxygen saturation) and motion sensors to assess exercise execution and adherence. All data are transmitted securely and stored automatically in the system's database. In addition to the exercise protocol, participants undergo baseline and follow-up assessments including blood biomarkers, echocardiography, cardiopulmonary exercise testing, and quality-of-life questionnaires.

BEHAVIORAL

TELEREHABILITATION-NO

This intervention involves a traditional 8-week cardiac rehabilitation program carried out at a hospital-based outpatient facility. Patients attend sessions in person under the direct supervision of a physiotherapist. Each session includes warm-up, endurance training using a stationary bike, and cooldown. Vital signs (e.g., heart rate, blood pressure, oxygen saturation) are monitored manually by the physiotherapist, and exercise tolerance is assessed using standardized clinical scales (e.g., Borg and RPE). In addition to the exercise protocol, participants undergo baseline and follow-up assessments including blood biomarkers, echocardiography, cardiopulmonary exercise testing, and validated quality-of-life questionnaires. This group serves as the control for evaluating the effectiveness of the home-based telerehabilitation model.

All Listed Sponsors
collaborator

Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

OTHER

lead

University of Salerno

OTHER

NCT07023536 - Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure | Biotech Hunter | Biotech Hunter