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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Hospital University San Giovanni di Dio e Ruggi d'Aragona
RECRUITING
Salerno
Contact Information
Primary
Alessia Bramanti, Electronic Engineering
abramanti@unisa.it
+393483809181
Time Frame
Start Date: 2025-06-10
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 205
Treatments
TELEREHABILITATION-YES (Intervention Group)
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.
TELEREHABILITATION-NO (Control Group)
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.
Related Therapeutic Areas
Sponsors
Collaborators: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Leads: University of Salerno

This content was sourced from clinicaltrials.gov