Effect of Inspiratory Muscle Training on Exercise Capacity, Dyspnea & Cardiac Autonomic Function in Individuals with Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Exercise capacity will be assessed by six-minute walk distance calculated measured by six-minute walk test
研究概览
简要总结
This study is a randomized, double-blind, parallel group, single-centre trial to determine the effect of inspiratory muscle training on exercise capacity, dyspnea and cardiac autonomic function in individuals with COPD. The recruited subjects will be randomized in two-groups: group-A (experimental group) and group-B (control group). Group-A will be given inspiratory muscle training and pulmonary rehabilitation and group-B will be given sham training and pulmonary rehabilitation, three times a week for eight weeks. The primary outcome is exercise capacity, will be measured with six-minute walk distance, secondary outcomes are dyspnea and cardiac autonomic function will be measured with rate of perceived exertion and heart rate variability respectively. The outcomes will be assessed at time points T0 (at the time of allotment) and T1 (after the training).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •GOLD classification of COPD: moderate to severe Inspiratory muscle weakness ( PI max< 70 cm H2O).
排除标准
- •Subjects on mechanical ventilators, Subjects with acute myocardial infarction within 3 months before inclusion, Diagnosed history of unstable angina and unstable ventricular arrhythmia within the last 3 months prior to initiation, Subjects with acute respiratory disease other than COPD, rheumatoid disease, and degenerative disease.
结局指标
主要结局
Exercise capacity will be assessed by six-minute walk distance calculated measured by six-minute walk test
时间窗: Six-minute walk distance will be measured at baselines and after 8 weeks of intervention.
次要结局
- Dyspnea will be assessed by baseline & transition dyspnea index scale & Cardiac autonomic function will be assessed by heart rate variability(Secondary outcomes will be assessed at the baseline before allotment & at the end of 8 weeks of intervention training)