An interventional study of Home-Based Cardiac Rehabilitation and Hospital-Based Cardiac Rehabilitation in Heart Failure and Cardiac Rehabilitation, sponsored by Azienda Ospedaliero Universitaria di Sassari. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Azienda Ospedaliero Universitaria di Sassari · Not applicable, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's enrollment of 30 is below the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Azienda Ospedaliero Universitaria di Sassari is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
- 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:
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
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
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.
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.
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.
Time frame: Baseline and Week 4 (within 7 days after the last session)
Adherence to Cardiac Rehabilitation
Adherence defined as the proportion of completed rehabilitation sessions relative to those scheduled, expressed as a percentage.
Time frame: At the end of the rehabilitation program
Quality of Life (KCCQ)
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.
Time frame: Baseline and Week 4 (within 7 days after the last session)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Ospedaliero Universitaria di Sassari