Tele-rehabilitation Versus Center-based Rehabilitation in Patients With Heart Failure: a Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Functional Capacity (6-Minute Walk Test)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Home-Based Cardiac Rehabilitation (Other)
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.
干预措施: Hospital-Based Cardiac Rehabilitation (Other)
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.
干预措施: Home-Based Cardiac Rehabilitation (Other)
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.
干预措施: Hospital-Based Cardiac Rehabilitation (Other)
结局指标
主要结局
Functional Capacity (6-Minute Walk Test)
时间窗: 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.
次要结局
- 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))
研究者
Valentina Micheluzzi
PhD
Azienda Ospedaliero Universitaria di Sassari