NCT03205878Unknown不适用
Improving Physical Activity in Obstructive Sleep Apnea Patients Treated With Continuous Positive Airway Pressure
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 102
- 主要终点
- Change in steps per day after 3 months
研究概览
简要总结
Patients with obstructive sleep apnea (OSA) are less physically active than healthy controls.
First choice of treatment for OSA is continuous positive airway pressure (CPAP) therapy with an improvement in oxygen saturation and sleep. No improvement on physical activity has been shown.
The current study would randomize patients in a standard care group (CPAP) and an intervention group (CPAP + telecoaching). Telecoaching will be performed for 3 months, with physical activity assessment before, after 3 months and 12 years.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AHI > 15 events/hour, measured by polysomnography
- •< 7,500 steps per day
- •Willing to start CPAP treatment
- •Age between 18 and 65 years
- •Signing the written informed consent
排除标准
- •Patients with neuromuscular diseases
- •Patients with chronic obstructive pulmonary disease and interstitial lung disease
- •Patients with cardiac failure and ischemic heart failure
- •Patients with comorbidities which could interfere with a normal biomechanical gait pattern and the possibility of increasing physical activity
- •Patients with mental disability making it impossible to understand the study protocol and the use of electronic devices.
结局指标
主要结局
Change in steps per day after 3 months
时间窗: The change will be measured after 3 months
Steps per day as measured by a step counter
次要结局
- Change in functional exercise capacity(3 months and 12 months compared with baseline)
- Change in daytime sleepiness(3 months and 12 months compared with baseline)
- Change in body composition(3 months and 12 months compared with baseline)
- Change in quality of life(3 months and 12 months compared with baseline)
- The proportion of patients with an increase > 1,000 steps per day(After 3 months (end of telecoaching) and after 12 months)
- Change in sleep quality(3 months and 12 months compared with baseline)
- Change in endothelial function(3 months and 12 months compared with baseline)
- Change in steps per day after 12 months(The change will be measured after 12 months)
- The proportion of patients with > 7500 steps/day(Before initiation of telecoaching (baseline), after 3 months (end of telecoaching) and after 12 months)
研究者
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