Effect of Inspiratory Muscle Training Versus Transcutaneous Electrical Diaphragmatic Stimulation on The Severity of Copd
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The COPD Assessment Test (CAT)
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a common and treatable disease characterized by progressive airflow limitation and tissue destruction. It is associated with structural lung changes due to chronic inflammation from prolonged exposure to noxious particles or gases most commonly cigarette smoke.
POWERbreathe device (POWER-breathe International Ltd., Southam, Warwickshire, UK) is an inspiratory muscle training and this device has recently shown benefits on pulmonary function. Also, the POWER-breathe® device's effects on the strength of the diaphragm muscle and minimize muscle weakness and wasting in COPD patients.
Neuromuscular electrical stimulation (NMES) is commonly used in physical therapy to increase muscle strength and promote muscle hypertrophy. NMES applied to respiratory rehabilitation is called transcutaneous electrical diaphragmatic stimulation (TEDS).
详细描述
sixty Patients will be assigned randomly into two equal groups with pre and post treatment protocol application.
Group A:
Thirty patients will be treated by power breathe along with their prescribed medication.
Group B:
Thirty patients will be treated by Transcutaneous electrical Diaphragmatic Stimulation (TEDS) along with their prescribed medication.
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
- 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
- •The patient selection will be according to the following criteria:
- •Male patients diagnosed with stage 2&3 COPD.
- •All patients are under full medical control.
- •Their ages will range from forty-five to sixty-five years.
- •Patients with BMI from 25-29.9 kg/m2
排除标准
- •Patients with the following criteria will be excluded from the study:
- •Lack of language or cognitive abilities to fill out questionnaire.
- •Patients with cardiac pacemaker.
- •Contraindications for inspiratory muscle training (e.g. a history of recent lung surgery, recent pulmonary embolism, history of recurrent spontaneous pneumothorax, other serious lung disease).
- •Existing arterial aneurysm.
- •Clinical signs of unstable cardiac event (eg. congestive heart failure).
- •Patients with malignant disease.
- •Acute COPD exacerbation within the last 4 weeks.
- •Any need for supplemental oxygen.
- •Patients with Gastro-esophageal reflux disease.
- •Patients with active Hemoptysis.
结局指标
主要结局
The COPD Assessment Test (CAT)
时间窗: COPD Assessment Test will be measured at baseline, and it will be measured again after eight weeks
The COPD Assessment Test(CAT) is validated questionnaire consisting of eight items, which evaluate the most burdensome symptoms and limitations of the patients. The score for each item ranges from 0 to 5 and the total score (0-40)
次要结局
- Measuring functional capacity: By Six-minute walk test (6MWT):(Measuring functional capacity: By Six-minute walk test (6MWT)::will be measured at baseline, and it will be measured again after eight weeks)
- Pulmonary function: By Spirometry Device:(Pulmonary function: By Spirometry Device: forced expiratory flow will be measured at baseline, and it will be measured again after eight weeks)
- Diaphragmatic Thickness: By Ultrasonography:(Diaphragmatic Thickness: By Ultrasonography:will be measured at baseline, and it will be measured again after eight weeks)
- Modified Medical Research Council dyspnea scale (mMRC dyspnea scale):(Modified Medical Research Council dyspnea scale (mMRC dyspnea scale):will be measured at baseline, and it will be measured again after eight weeks)
研究者
Alaa Mohamed El-Moatasem Mohamed
lecturer of physical therapy
Cairo University