Tele-rehabilitation Versus Center-based Rehabilitation in Heart Failure Patients (HereRehab-HF)

April 16, 2026 updated by: Valentina Micheluzzi, Azienda Ospedaliero Universitaria di Sassari

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • SS
      • Sassari, SS, Italy, 07100
        • Valentina Micheluzzi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hospital-Based Cardiac Rehabilitation
Participants receive standard hospital-based cardiac rehabilitation. The program consists of eight sessions performed twice weekly and includes the same aerobic and anaerobic/calisthenic exercises as the intervention group. All sessions are delivered in the hospital setting under direct supervision by healthcare professionals. The assessment schedule and outcome measurements are identical to those of the intervention group.
Other: Home-Based Cardiac Rehabilitation
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.
Other: Hospital-Based Cardiac Rehabilitation
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.
Experimental: Home-Based Cardiac Rehabilitation (HERE)
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.
Other: Home-Based Cardiac Rehabilitation
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.
Other: Hospital-Based Cardiac Rehabilitation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 4 (within 7 days after the last session)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of the rehabilitation program
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.
Baseline and Week 4 (within 7 days after the last session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero Universitaria di Sassari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2025

Primary Completion (Actual)

December 23, 2025

Study Completion (Actual)

December 23, 2025

Study Registration Dates

First Submitted

April 5, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOSassari_HF_2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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