Effect of Breather on Ventilatory and Vascular Function in Chronic Obstructive Pulmonary Disease Patients with Intermittent Claudication.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ventilatory function: by spirometry test
研究概览
简要总结
The aim of this study To show the effect of breather on ventilatory and vascular function in COPD patient with intermittent claudication.
详细描述
recent researches show that COPD patients have risk of developing peripheral arterial disease (PAD) which represented on patient by intermittent claudication inspiratory muscle trainer as the breather device show increasing in inspiratory muscle strength and endurance; reduction of dyspnea; and improving of exercise tolerance .
Because of all this things this study tends to show the effect of the breather on ventilatory and vascular function in COPD patient with intermittent claudication.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •sixty male patients with diagnosed with grade I and grade II COPD their ages ranged between 55-60years
- •All patients will be clinically and medically stable when attending the study.
- •Body mass index (BMI) is 18.5 to 24.9 kg/m
- •History of unilateral exertional leg pain,
- •Ambulation during a graded treadmill test limited by leg pain consistent with intermittent claudication (stage II of the fontaine classification of pad),
- •And an ankle-brachial index (ABI) of 0.90 or lower at rest or 0.73 or lower after exercise.
排除标准
- •cardiovascular insufficiency,
- •Recent myocardial infarction,
- •heart failure,
- •arrhythmia,
- •Intracranial hypertension,
- •Pneumonia,
- •kidney failure,
- •fractures,
- •uncooperative patients,
- •cognitive impairment preventing a patient from participation in exercises.
研究组 & 干预措施
treatment group
This group include 30 patients with COPD and intermittent claudication. These patients can receive aerobic exercise (by applying treadmill exercise for 20 min) and inspiratory muscle training (by using The BREATHER device with Light/Medium resistance for 3-5 sets /session), for 4 weeks (3 sessions per week) and pursed lip breathing.
干预措施: The BREATHER (Device)
control group
This group include 30 patients with COPD and intermittent claudication. These patients can receive pursed lip breathing and aerobic exercise (by applying treadmill exercise for 20 min) with the usually pharmacological treatment, for 4 weeks (3 sessions per week).
干预措施: pharmacological treatment (Drug)
结局指标
主要结局
Ventilatory function: by spirometry test
时间窗: 4 weeks
Spirometry is a physiological test that measures the ability to inhale and exhale air relative to time.
Vascular function: by doppler ultrasound
时间窗: 4 weeks
Doppler ultrasound is a simple and non-invasive and method for the evaluation of early atherosclerosis. It can be used as a screening program for PAD in populations with high risk for atherosclerosis.
次要结局
- Functional capacity assessment: by 5 repetitions sit to stand test (5R-STS)(4 weeks)
- Treadmill exercise testing(4 weeks)
研究者
Reem Medhat Mohamed Ali Farahat
demonstrator
Cairo University