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

NCT07539493 | Completed

• 1 other identifier: AOSassari_HF_2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Functional Capacity (6-Minute Walk Test)

  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 Outcomes (2)

• Adherence to Cardiac Rehabilitation

  At the end of the rehabilitation program

• Quality of Life (KCCQ)

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

Study Arms (2)

Hospital-Based Cardiac Rehabilitation

ACTIVE COMPARATOR

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; Other: Hospital-Based Cardiac Rehabilitation

Home-Based Cardiac Rehabilitation (HERE)

EXPERIMENTAL

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; Other: Hospital-Based Cardiac Rehabilitation

Interventions

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.

Home-Based Cardiac Rehabilitation (HERE); Hospital-Based Cardiac Rehabilitation

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.

Home-Based Cardiac Rehabilitation (HERE); Hospital-Based Cardiac Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria di Sassari: lead

Study Sites (1)

Valentina Micheluzzi

Sassari, SS, 07100, Italy

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 20, 2026
• Study Start: July 31, 2025
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

IT (1)