Implementation of Telerehabilitation In Support of HOme-based Physical Exercise for Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Improvement in long-term physical activity.
研究概览
简要总结
ITISHOPE4HF is a randomized controlled trial of telerehabilitation in a heart failure population. The goal is to evaluate if a home-based telerehabilitation project can increase physical activity in heart failure patients. Patients will be provided telerehabilitation or advice on physical activity (standard care).
详细描述
Outpatient cardiac rehabilitation programs are well documented as an important part of treatment and care for heart failure patients. Training with instruction gives the participant a commitment to participate. The result is increased activity compared to controls.
This trial will include participants from the about 75 % of heart failure patients who for some reason do not participate in regular outpatient rehabilitation. Distance to rehabilitation centers and the psychological burden of a group setting are believed to be important reasons for not participating. Telerehabilitation can hopefully overcome these hurdles for many patients, and thereby provide instructed training for these patients.
The trial will also include patients with renal disease. Heart disease is the main cause of death in patients with renal disease, even at younger ages. Because of the complexity of both optimal medical treatment and fluid balance, these patients are often not included in clinical trials. The cardiorenal crosstalk will be explored, how in influence the heart failure phenotypes and the response to exercise.
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)
盲法说明
Group assignment is not masked at performance tests. Group assignment is masked to the echo/MRI technician, and for investigators interpreting the recordings.
Masking is not relevant for laboratory analysis.
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
- •Heart failure (HFpEF or HFrEF) according to European guidelines.
- •Moderate or severe signs and symptoms of heart failure (NYHA II-III) in the 6 months prior to enrolment.
- •N-terminal pro brain natriuretic peptide (NT-proBNP) > 300 pmol/L.
- •Stable (> 4 weeks) medical therapy for risk factor control.
- •Capability to provide signed, informed, written consent.
排除标准
- •Attendance at a rehabilitation program in the 6 months prior to enrolment.
- •Non-heart failure causes of heart failure symptoms (significant valvular disease, coronary disease available for revascularization, uncontrolled hypertension, arrhythmia).
- •severe or very severe pulmonary disease (eg. COPD GOLD III-IV).
- •presence of conditions which might prevent patients from safely exercising at home.
结局指标
主要结局
Improvement in long-term physical activity.
时间窗: 2 years
Change in physical activity between intervention and control group measured throughout the study with Actigraph activity trackers from baseline to 2 years.
次要结局
- Effects on endothelial function.(2 years.)
- Changes in cardiac structure and function.(2 years.)
- Change in physical fitness.(2 years)
- Effects on renal function.(2 years.)
- Change in long-term quality of life.(2 years.)
- Mid-term mortality(2 years)
- Long-term effects on cardiovascular risk factors.(2 years.)
- Mid-term morbidity(2 years)