Effect of Pedometer-Based Walking Intervention on Functional Capacity and Neurohumoral Modulation in Patients With Chronic Heart Failure With Reduced Ejection Fraction: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- functional capacity
研究概览
简要总结
A multicenter randomized controlled trial, with follow-up at 6 and 12 months. Physically inactive participants with chronic heart failure with reduced ejection fraction will be randomly assigned to intervention or control arms.
The six-month intervention will consist of an individualized pedometer-based walking program with weekly step goals, monthly face-to-face sessions with the physician, and monthly telephone calls with the research nurse. The intervention will be based on effective behavioral principles (goal setting, self-monitoring, personalized feedback).
The primary outcome is the change in 6-minute walk distance at 6 months. Secondary outcomes include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound, average daily step count measured by accelerometry, anthropometric measures, symptoms of depression, health-related quality of life, self-efficacy, and MAGGIC Risk Score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Diagnosis of heart failure with reduced ejection fraction (left ventricular ejection fraction <40%) with New York Heart Association (NYHA) class II or III symptoms.
- •Physically inactive, as determined by a question "As a rule, do you do at least half an hour of moderate or vigorous exercise (such as walking or a sport) on five or more days of the week?".
排除标准
- •Signs and symptoms of decompensated heart failure, uncontrolled arrhythmia or effort angina, severe or symptomatic aortic stenosis, persistent hypotension, recent shocks delivered by the automated implantable cardioverter defibrillator.
- •Co-morbid conditions that would affect adherence to trial procedures (e.g. inflammatory arthritis, active malignancy, renal disease requiring dialysis, uncontrolled diabetes, major depression or other significant psychiatric disorders, cognitive impairment, significant hearing or visual impairment).
- •Major surgery planned within the next 12 months.
- •Life expectancy shorter than 12 months.
- •Inability to walk from any reason.
- •Baseline six-minute walking distance >450 meters. Patients covering more than 450 meters in the baseline six-minute walk test (6MWT) are excluded due to a possible ceiling effect.
- •Failure to perform the 6MWT.
结局指标
主要结局
functional capacity
时间窗: 6 months
functional capacity change measured with 6-minute walk test
次要结局
- NT-proBNP(6 months)
- hsCRP(6 months)
- health-related quality of life(6 and 12 months)
- pulmonary congestion(6 and 12 months)
- hip circumference(6 and 12 months)
- Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) Risk Score(6 and 12 months)
- physical activity(6 and 12 months)
- depression(6 and 12 months)
- body mass index(6 and 12 months)
- functional capacity(12 months)
- self-efficacy(6 and 12 months)
- waist circumference(6 and 12 months)
研究者
Jan Belohlavek
Ass. Prof.
Charles University, Czech Republic