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Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Salerno

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age < 18 years

Pregnancy

NYHA class IV heart failure

Severe renal insufficiency (eGFR <30 ml/min/1.73 m²) or on dialysis

Trial population

dults aged 18 years or older with a diagnosis of chronic heart failure, including heart failure with reduced ejection fraction (HFrEF), mildly reduced ejection fraction (HFmrEF), or preserved ejection fraction (HFpEF), and classified as NYHA functional class I to III, referred for cardiac rehabilitation at a tertiary care center. Participants must be clinically stable, receiving optimal medical therapy, and able to participate in either an in-person or home-based telerehabilitation program. Digital literacy, either of the patient or a caregiver, is required for inclusion in the telerehabilitation group. Both sexes are included. Patients with severe comorbidities that significantly limit life expectancy or with NYHA class IV heart failure are excluded.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • TELEREHABILITATION-YES

    Behavioral

    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 monitoring of vital signs (ECG, heart rate, blood pressure, oxygen saturation) and motion sensors to assess exercise execution and adherence. All data are transmitted securely and stored automatically in the system's database. In addition to the exercise protocol, participants undergo baseline and follow-up assessments including blood biomarkers, echocardiography, cardiopulmonary exercise testing, and quality-of-life questionnaires.

  • TELEREHABILITATION-NO

    Behavioral

    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., Borg and RPE). In addition to the exercise protocol, participants undergo baseline and follow-up assessments including blood biomarkers, echocardiography, cardiopulmonary exercise testing, and validated quality-of-life questionnaires. This group serves as the control for evaluating the effectiveness of the home-based telerehabilitation model.

Treatment groups

205 Participants
are divided into 2 treatment groups
Group A: TELEREHABILITATION-YES (Intervention Group)1 intervention
Group B: TELEREHABILITATION-NO (Control Group)1 intervention

Trial outcomes

Primary outcomes

1

Change in VO₂max from baseline to 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.

Time frame
Baseline (T=0) and end of intervention (T=2, 8 weeks)

Secondary outcomes

1

VO₂max at 24-week follow-up

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.

Time frame
follow-up (T=4, 24 weeks)
2

Change in functional capacity assessed by 6-minute walk test (6MWT)

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.

Time frame
Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
3

Change in Quality of Life

Quality of life (QoL) will be measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score, a validated instrument specifically designed to assess symptom burden, functional status, social limitations, and quality of life in patients with chronic heart failure (CHF). The score ranges from 0 to 100, where higher scores indicate better health status and quality of life.

Time frame
Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
4

Change in Quality of Life

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.

Time frame
Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)

Other outcomes

Sponsors and contacts

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University of Salerno

Lead sponsor

Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

Collaborator

Source ClinicalTrials.gov
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