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NCT07539493Completed

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

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

Source: ClinicalTrials.gov · Last updated 20 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
30 (actual)
First submitted
5 Apr 2026
Start date
31 Jul 2025
Primary completion date
23 Dec 2025
Lead sponsor
Azienda Ospedaliero Universitaria di Sassari
NCT number
NCT07539493

What you commit to

  • Study type: Interventional
  • Participants enrolled: 30
  • From 31 Jul 2025 to the primary completion date, 23 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Who the study is looking for

  • \- 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Valentina Micheluzzi
Coordinator of this site? Confirm its status
SassariItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.