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Completed

NCT Number: NCT07539493

Tele-rehabilitation Versus Center-based Rehabilitation in Heart Failure Patients

This study is a single-center pilot randomized controlled trial designed to compare home-based cardiac rehabilitation delivered through the HERE solution with standard hospital-based cardiac rehabilitation in patients with clinically stable heart failure. Cardiac rehabilitation is recommended to improve functional capacity and clinical outcomes in this population; however, adherence to conventional center-based programs remains suboptimal.

The intervention consists of a structured rehabilitation program delivered over eight sessions, including aerobic and calisthenic exercises, supported by a tablet-based application with real-time monitoring and feedback. Participants in the control group receive the same rehabilitation program in a hospital setting under direct supervision.

The primary objective of the study is to evaluate the effectiveness of the intervention on functional capacity, measured using the 6-minute walk test. Secondary outcomes include adherence to the rehabilitation program, quality of life, exercise capacity parameters, vital signs, perceived exertion, and patient satisfaction.

This pilot study aims to assess the feasibility and preliminary effectiveness of a technology-supported home-based rehabilitation model to inform the design of future larger trials.

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Key information

Conditions

Heart Failure Cardiac Rehabilitation Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valentina Micheluzzi

Sassari, SS, 07100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years Diagnosis of clinically stable heart failure New York Heart Association (NYHA) class I-II Enrollment in a cardiac rehabilitation program Availability of a stable Wi-Fi connection and a smartphone at home Presence of a caregiver trained in the use of the study technology Ability and willingness to provide written informed consent

Exclusion criteria

  • Conditions precluding physical exercise (e.g., bone fractures) Conditions preventing the use of the study technology (e.g., blindness or deafness) Severe cognitive impairment (Six-Item Screener score 0-4) End-stage renal disease requiring dialysis Advanced pulmonary disease Active malignancy Rheumatic disease

Treatment and study plan

Home-Based Cardiac Rehabilitation

Other

A home-based cardiac rehabilitation program delivered through the HERE solution, consisting of eight sessions performed twice weekly. The intervention includes aerobic exercise using a chair cycle ergometer and anaerobic/calisthenic exercises. The program is supported by a tablet-based application providing guided exercises, real-time monitoring of physiological parameters (heart rate, oxygen saturation, and blood pressure), and feedback. Participants receive prior training on the use of the technology and exercise execution.

Hospital-Based Cardiac Rehabilitation

Other

A standard hospital-based cardiac rehabilitation program consisting of eight sessions performed twice weekly. The program includes aerobic exercise and anaerobic/calisthenic exercises delivered in the hospital setting under direct supervision by healthcare professionals.

Primary outcomes

  1. Functional Capacity (6-Minute Walk Test)

    Time frame: Baseline and Week 4 (within 7 days after the last session)

    Functional capacity assessed using the 6-minute walk test (6MWT), defined as the distance walked in meters on a flat surface in 6 minutes. Higher values indicate better functional capacity.

Secondary outcomes

  1. Adherence to Cardiac Rehabilitation

    Time frame: At the end of the rehabilitation program

    Adherence defined as the proportion of completed rehabilitation sessions relative to those scheduled, expressed as a percentage.

  2. Quality of Life (KCCQ)

    Time frame: Baseline and Week 4 (within 7 days after the last session)

    Quality of life assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a 23-item validated instrument with scores ranging from 0 to 100, with higher scores indicating better health status.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero Universitaria di Sassari

Other

Registry information

Official study title

Tele-rehabilitation Versus Center-based Rehabilitation in Patients With Heart Failure: a Pilot RCT

Acronym: HereRehab-HF

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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