Evaluation of the Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Change in VO₂max from baseline to 8 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: TELEREHABILITATION-YES (Behavioral)
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.
干预措施: TELEREHABILITATION-NO (Behavioral)
结局指标
主要结局
Change in VO₂max from baseline to 8 weeks
时间窗: Baseline (T=0) and end of intervention (T=2, 8 weeks)
The primary outcome is the change in maximal oxygen consumption (VO₂max) from baseline to 8 weeks in patients with chronic heart failure undergoing a cardiac telerehabilitation program compared to a traditional in-person rehabilitation program. VO₂max is assessed via cardiopulmonary exercise testing (CPET). The intervention aims to achieve a clinically meaningful increase of approximately 20% in VO₂max. VO₂max is a key marker of functional capacity and cardiovascular health, and its improvement is associated with better prognosis, reduced hospitalizations, and enhanced quality of life.
次要结局
- VO₂max at 24-week follow-up(follow-up (T=4, 24 weeks))
- Change in functional capacity assessed by 6-minute walk test (6MWT)(Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4))
- Change in cognitive function assessed by Mini-Mental State Examination (MMSE)(Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4))
- Change in physical performance assessed by Short Physical Performance Battery (SPPB)(Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4))
- Change in Quality of Life(Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4))
- Change in Biochemical Parameters(Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4))
- Change in Functional ECG-Derived Parameters(Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4))
- Change in Functional Echocardiographic derived Parameters(Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4))
研究者
Alessia Bramanti
Associate Professor
University of Salerno