NCT05873543招募中不适用
The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change of peak oxygen uptake
研究概览
简要总结
The aim of this randomized controlled trial is to compare the impact of a case manager-led smartphone-assisted hybrid cardiac rehabilitation program with usual care in patients with HF. Participants will undergo a 12-week program led by a case manager and assisted by a smartphone. The study aims to answer two main questions:
- Is the novel cardiac rehabilitation model feasible for patients with HF?
- Does the intervention group show a significant improvement in exercise capacity and adherence compared to the usual care group?
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with heart failure between the ages of 18 and 80 years old.
- •NYHA (New York Heart Association) functional classification of 1 to
- •Patients must be in a stable condition and under outpatient follow-up.
排除标准
- •Patients who have contraindications for exercise according to the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription.
- •Patients who are unable to complete cardiopulmonary exercise testing.
- •Patients who are unable to follow verbal instructions.
- •Patients who are unable to walk independently or pedal a stationary bicycle.
- •Patients who are unable to use communication app on a smartphone.
- •Patients who already engage in physical activity exceeding the recommended moderate intensity of 150 minutes per week or are currently participating in cardiac rehabilitation.
- •Patients who do not provide consent to participate in the trial.
结局指标
主要结局
Change of peak oxygen uptake
时间窗: at baseline, 12 weeks(post-intervention), and 6 months.
Peak oxygen uptake will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 6 months.
Change of 6 minute walking test
时间窗: at baseline, 12 weeks(post-intervention), and 6 months.
6 minute walking test will be performed before intervention, at 12 weeks (post-intervention), and at 6 months.
次要结局
- Adherence to prescribed exercise(12 weeks(post-intervention))
- Depression(at baseline, 12 weeks(post-intervention), and 6 months.)
- Blood test: Triglyceride(at baseline, 12 weeks(post-intervention), and 6 months.)
- Evaluation of Quality of life(at baseline, 12 weeks(post-intervention), and 6 months.)
- Evaluation of physical activity(at baseline, 12 weeks(post-intervention), and 6 months.)
- Anxiety(at baseline, 12 weeks(post-intervention), and 6 months.)
- Evaluation of grip strength(at baseline, 12 weeks(post-intervention), and 6 months.)
- Blood test: HDL(at baseline, 12 weeks(post-intervention), and 6 months.)
- Evaluation of frailty(at baseline, 12 weeks(post-intervention), and 6 months.)
- Blood test: Total cholesterol(at baseline, 12 weeks(post-intervention), and 6 months.)
- Blood test: LDL(at baseline, 12 weeks(post-intervention), and 6 months.)
- Blood test: NT-proBNP(at baseline, 12 weeks(post-intervention), and 6 months.)
研究者
研究点 (2)
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