Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure

Not yet recruiting

• Conditions: Heart Failure

• Registration Number: NCT07023536
• Lead Sponsor: University of Salerno

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-08
• Study First Submitted QC: 2025-06-08
• Study First Posted: 2025-06-17
• Last Update Submitted: 2025-06-17
• Last Update Posted: 2025-06-22
• Study Start: 2025-07-01
• Primary Completion: 2026-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 205

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in VO₂max from baseline to 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
VO₂max at 24-week follow-up	follow-up (T=4, 24 weeks)	This outcome assesses VO₂max measured at 24 weeks following the end of the intervention period, in order to evaluate the evolution of functional capacity over time. VO₂max is assessed using cardiopulmonary exercise testing (CPET) at baseline, 8 weeks, and 24 weeks. The analysis will examine whether any changes observed after the intervention are sustained, reversed, or further modified at follow-up.
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)	Functional capacity will be measured using the 6-minute walk test (6MWT), a validated submaximal exercise test in heart failure patients. The distance walked will be recorded at baseline, after the 8-week intervention, and at 24-week follow-up. Improvements in distance will reflect better exercise tolerance, which is a relevant indicator of clinical status and therapeutic efficacy.
Change in Quality of Life	Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)	The Short Form Health Survey - 36 items (SF-36) evaluates general health status across multiple domains, including physical functioning, role limitations, pain, general health, vitality, social functioning, emotional well-being, and mental health. The total score ranges from 0 to 100, with higher scores indicating better health status and quality of life.
Change in Biochemical Parameters	Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)	Biochemical Parameters: Change in Serum Chloride Levels (millimoles per liter)
Change in Functional ECG-Derived Parameters	Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)	ECG-Derived Parameters: Change in Respiratory Rate (breaths per minute)
Change in Functional Echocardiographic derived Parameters	Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)	Echocardiographic Parameters: Change in Left Ventricular End-Systolic Volume (milliliters)
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)	Cognitive function will be assessed using the Mini-Mental State Examination (MMSE), a widely used screening tool for cognitive impairment. The MMSE evaluates orientation, attention, memory, language, and visuospatial skills. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. Scores will be collected to monitor changes in cognitive status over time in patients participating in the cardiac rehabilitation program.
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 physical performance will be assessed using the Short Physical Performance Battery (SPPB), which includes tests of balance, gait speed, and chair stands. The SPPB provides a composite score ranging from 0 to 12, with higher scores indicating better lower extremity function and physical performance.