Impact of Aerobic Training on Sleep Quality and Aerobic Fitness in Male Patients With Pulmonary Artery Hypertension: a Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Subjective self-report questionnaire that assesses sleep quality
研究概览
简要总结
This study investigated the effect of 12 weeks of aerobic training on sleep quality and aerobic fitness in patients with Pulmonary arterial hypertension(PAH).
详细描述
Thirty male PAH patients were included in the study. They were randomized into two equal groups; Training group (A) and Control group(B). Right ventricular systolic pressure (RVSP) measured using Doppler Echocardiography , Pittsburg sleep quality index (PSQI) questionnaire with the wrist worn actigraph used for the assessment of sleep disturbance, and Cardiopulmonary exercise testing (CPET) measurements included maximal heart rate and VO2max .All were measured before and after the study period for both groups.The training was a moderate intensity aerobic training on a bicycle ergometer (corresponding to 60% to 70% of the maximal heart rate they reach during peak oxygen uptake in the initial exercise test) for 30 to 45 min/day, 3 sessions/week for 12 weeks (36 sessions).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients who were clinically stable and compensated under optimized medical therapy
- •World health organization (WHO) Classification of functional class II to III PAH
- •Patients with ejection fraction ≥ 40%
- •Non-smokers
- •body mass index ≤ 35 kg/m2
排除标准
- •Any patient with respiratory failure
- •unstable angina
- •renal, hepatic or neuromuscular disorders
- •history of syncopal attacks
- •uncontrolled systemic hypertension
- •peripheral vascular disease
- •serious cardiac dysrhythmias on resting ECG
- •evidence of severe COPD at pulmonary function testing,
- •any known musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise
结局指标
主要结局
Subjective self-report questionnaire that assesses sleep quality
时间窗: change from baseline at 12 weeks
The Pittsburgh Sleep Quality Index is a subjective self-report questionnaire that assesses sleep quality over a 1-month time interval in different populations It is 5 points score (0 means normal, 5 means severe sleep disturbance)
Determining sleep patterns
时间窗: change from baseline at 12 weeks
Determining sleep patterns by using actigraph to assess suspected certain sleep disorders,
Measuring aerobic fitness
时间窗: change from baseline at 12 weeks
Level of aerobic fitness assessed by using Cardiopulmonary exercise testing (CPET) through incremental exercise intensity until voluntary exhaustion.
Pulmonary artery systolic pressure (PASP)
时间窗: change from baseline at 12 weeks
Pulsed Doppler Echocardiogram for assessing PASP as calculated from the gradient across the tricuspid valve using the modified Bernoulli equation.
次要结局
未报告次要终点
研究者
Heba Ahmed Ali Abdeen
Assistant Professor
Cairo University