RecruitingNCT07023536

Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure

Evaluation of the Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure

Sponsor

University of Salerno

Enrollment

205 participants

Start Date

Jun 10, 2025

Study Type

OBSERVATIONAL

Conditions

Heart Failure

Summary

The goal of this observational study is to evaluate whether a home-based cardiac tele-rehabilitation program can improve functional capacity in adults (18 years and older) with chronic heart failure. The main questions it aims to answer are: Does tele-rehabilitation improve peak oxygen uptake (VO₂ max) compared to standard in-hospital rehabilitation? Does it improve cardiac function, exercise tolerance, biochemical markers, and quality of life? Are functional gains maintained at 24 weeks? Researchers will compare patients who opt for tele-rehabilitation using wearable devices and a remote monitoring platform with those undergoing standard in-person rehabilitation. Participants will follow an 8-week individualized training program and undergo assessments at baseline, 4, 8, 16, and 24 weeks.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Age ≥ 18 years
Diagnosis of chronic heart failure for at least 6 months, with stable optimal medical therapy for at least 1 month
New York Heart Association (NYHA) functional class I, II, or III
Hospitalization or outpatient visit requiring intravenous therapy (diuretics, vasodilators, or inotropes) within the past 12 months
Ability to provide informed consent or presence of a legal representative
Digital literacy of the patient and/or caregiver

Exclusion Criteria5

Age \< 18 years
Pregnancy
NYHA class IV heart failure
Severe renal insufficiency (eGFR \<30 ml/min/1.73 m²) or on dialysis
Other serious illnesses significantly limiting life expectancy (e.g., end-stage cancer, advanced pulmonary disease)

Interventions

BEHAVIORALTELEREHABILITATION-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.

BEHAVIORALTELEREHABILITATION-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.