Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 monitor
• Поведенческое 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., Bor

Первичные конечные точки

• Change in VO₂max from baseline to 8 weeks [Срок оценки: Baseline (T=0) and end of intervention (T=2, 8 weeks)]

Вторичные конечные точки (12)

• VO₂max at 24-week follow-up [Срок оценки: follow-up (T=4, 24 weeks)]
• Change in functional capacity assessed by 6-minute walk test (6MWT) [Срок оценки: Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)]
• Change in Quality of Life [Срок оценки: Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)]
• Change in Quality of Life [Срок оценки: Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)]
• Change in Biochemical Parameters [Срок оценки: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)]
• Change in Biochemical Parameters [Срок оценки: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)]
• Change in Biochemical Parameters [Срок оценки: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)]
• Change in Biochemical Parameters [Срок оценки: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)]
• Change in Biochemical Parameters [Срок оценки: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)]
• Change in Biochemical Parameters [Срок оценки: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)]
• Change in Biochemical Parameters [Срок оценки: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)]
• Change in Functional ECG-Derived Parameters [Срок оценки: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• Hospital University San Giovanni di Dio e Ruggi d'Aragona — Salerno

Публикации

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Идентификаторы

NCT: NCT07023536 · UNISA-TELEREHABHF-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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