Cardiac Rehabilitation, Heart Failure
Conditions
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.
Interventions
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.
OTHERHospital-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.
Sponsors
Azienda Ospedaliero Universitaria di Sassari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Capacity (6-Minute Walk Test) | 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
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Cardiac Rehabilitation | At the end of the rehabilitation program | Adherence defined as the proportion of completed rehabilitation sessions relative to those scheduled, expressed as a percentage. |
| Quality of Life (KCCQ) | 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. |
Countries
Italy
Outcome results
None listed