Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure (TELEREHAB-HF)

University of Salerno

Status: Not yet enrolling

Conditions: Heart Failure

Treatments: Behavioral: TELEREHABILITATION-YES; Behavioral: TELEREHABILITATION-NO

Study type: Observational

Funder types: Other

Identifiers

NCT07023536

UNISA-TELEREHABHF-2025

Details and patient eligibility

About

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.

Full description

This prospective, single-center, non-pharmacological observational study aims to evaluate the effectiveness and feasibility of a structured, home-based cardiac telerehabilitation program in adults with chronic heart failure (CHF). The primary objective is to determine whether a telemedicine-based model can improve patients' functional capacity, as measured by maximal oxygen uptake (VO₂max), when compared to conventional in-hospital cardiac rehabilitation.

Participants will voluntarily enroll in either the telerehabilitation group or the standard rehabilitation group. Both groups follow the same 8-week aerobic exercise protocol, based on current international guidelines for heart failure management. The program includes warm-up, interval and endurance training, and cooldown, with exercise intensity personalized using cardiopulmonary exercise testing (CPET).

The telerehabilitation group will perform all sessions at home using a certified telehealth platform (Khymeia Virtual Reality Rehabilitation System - VRRS), which enables real-time supervision via secure videoconferencing. Participants are equipped with wearable medical-grade sensors for continuous monitoring of electrocardiogram (ECG), heart rate, blood pressure, and peripheral capillary oxygen saturation (SpO₂). The system offers automated data recording, performance feedback, and safety alerts, ensuring standardized care delivery and real-time clinical oversight. Before home-based training begins, participants receive structured in-person training to ensure safe and effective use of the digital tools.

Clinical and functional data are collected at baseline and follow-up visits at 4, 8, 16, and 24 weeks. The study also investigates patient adherence, safety, and the usability of digital rehabilitation tools. No investigational drugs or invasive procedures are involved. The findings will inform future implementation of scalable digital rehabilitation models in heart failure management and contribute to health system innovation in chronic disease care.

Enrollment: 205 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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)

Trial design

205 participants in 2 patient groups

TELEREHABILITATION-YES (Intervention Group)

Description:

Participants will receive a structured 8-week cardiac rehabilitation program conducted entirely at home through a certified telehealth platform (Khymeia VRRS system). The intervention includes real-time supervision by a physiotherapist via videoconferencing, and the use of wearable medical devices for continuous monitoring of vital signs (ECG, heart rate, SpO₂, blood pressure) and motion tracking. Each session includes warm-up, endurance training, and cooldown exercises, with intensity personalized based on baseline cardiopulmonary testing. The platform provides automated data recording, safety alerts, and performance feedback to ensure high-quality remote care. Patients are trained in-person before starting home-based sessions to ensure proper use of the system and adherence to the protocol.

Treatment:

Behavioral: TELEREHABILITATION-YES

TELEREHABILITATION-NO (Control Group)

Description:

Participants in this group will undergo a standard 8-week cardiac rehabilitation program delivered in person at the outpatient facility under direct supervision of a physiotherapist. This group receives face-to-face rehabilitation consisting of individualized exercise sessions performed at the hospital's cardiac rehabilitation unit. Each session includes warm-up, endurance training on a stationary bike, and cooldown, following international guidelines for heart failure patients. Vital signs (heart rate, blood pressure, oxygen saturation) are manually measured and recorded by the physiotherapist, who also administers fatigue and dyspnea scales (Borg and Rate of Perceived Exertion - RPE) throughout the program. No wearable technology is used in this group; monitoring is performed through direct clinical observation and documentation in the medical record.

Treatment:

Behavioral: TELEREHABILITATION-NO