Effect Of Breather On Pulmonary And Physical Function In Post Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- peak expiratory flow PEF in litres per second
研究概览
简要总结
Stroke is the second major cause of death and disability worldwide with over 13 million new cases annually.
Egypt, a low-middle-income country, is the most populated nation in the Middle East with a high overall crude prevalence rate of stroke (963/100,000 inhabitants), accounting for 6.4% of all deaths and the incidence of stroke annually is approximately 150,000-210,000.
Stroke has a direct impact on health systems, resulting in high costs, and is also considered a global public health problem due to serious disabilities, functional limitations and compromised quality of life (QoL).
The Breather a drug-free, evidence-based inspiratory/expiratory respiratory muscle training (RMT) device used by Dysphagia, COPD, CHF, Parkinson's, and neuromuscular disease patients, as well as children 4+ and adults interested in healthy aging.
详细描述
Stroke is a leading cause of death and disability in globally and particularly in low and middle-income countries, and this burden is increasing.
The expected spontaneous biological recovery follows the "proportional recovery rule" - most patients recover 70% of their impaired motor or verbal function during the first three months after stroke however, 90% of them have residual deficit.
Stroke patients may experience a reduction of up to 50% in respiratory function when compared to age- and gender-matched norms. The reduction in respiratory function can lead to decreased endurance, dyspnea and increased sedentary behaviour, as well as an elevated risk of recurrent stroke. The reduction in respiratory function may also cause aspiration, leading to pneumonia. Previous research showed that pneumonia was an independent risk factor for mortality and a poor prognosis in stroke patients. Research also showed that a reduction in respiratory muscle and abdominal muscle strength contributed to pulmonary and respiratory dysfunction following a stroke.
After a stroke, the respiratory center and related motor pathways can directly decrease respiratory muscle strength and subsequently induce a change in breathing patterns. As a result, pneumonia, pulmonary ventilation disorders, lung injury, lung ischemia reperfusion injury, decreased pulmonary compliance, abnormal posture, and obstructive sleep apnea can occur following a stroke. Thus, pulmonary rehabilitation is critical to reducing these complications. The main forms of pulmonary rehabilitation include exercise training, respiratory muscle training, oxygen therapy, noninvasive ventilation, nutrition support, social psychological support, and health education.
The inspiratory muscles can be specifically trained, with improvement of both muscle strength and endurance by using the breather device.
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
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sixty patients were selected from both sexes.Their age were from 50 to 65 years old
- •All patients were medically stable.
- •All patients had the ability to understand and follow simple verbal instructions.
- •All patients were in subacute stage from about 3 to 6 months post lesion.
排除标准
- •Patients with severe acute illness.
- •Chronic unstable pulmonary and/or cardiac disease.
- •Impaired level of consciousness and evidence of gross cognitive problems.
- •Patients undergoes chemotherapy.
- •Active hemoptysis, untreated pneumothorax, recent esophageal surgery.
- •Recent oral, facial or skull trauma / surgery, acute sinusitis, epistaxis.
- •Any oral dysfunction that interfere with using the breather.
- •Un controlled BP systole more than180 or diastole more than 90.
结局指标
主要结局
peak expiratory flow PEF in litres per second
时间窗: 6 weeks
fifty patients will be assessed for their PEF using spirometer
foced vital capacity FVC in litres
时间窗: 6 weeks
fifty patients will be assessed for their FVC using spirometer
forced expiratory volium in first second FEV1 in litres
时间窗: 6 weeks
fifty patients will be assessed for their FEV1 using spirometer
peak inspiratory flow PIF in litres per second
时间窗: 6 weeks
fifty patients will be assessed for their PIF using spirometer
次要结局
- six minute walk distance in metersused to assess functional capacity of patients(6 weeks)
- Chest expansion in centimeters using tape measurement(6 weeks)
- oxygen saturation in percentage using spirometer(6 weeks)
- stroke impact scale to assess the effect of stroke on different domains astanderdized score ranging from 0 to 100 is calculated for all domains with higher score indicating a higher quality of life(6 weeks)
研究者
Lamiaa Zakaria Abd El Salam Salama
principal investigatort
Cairo University