Effect of Inspiratory Muscle Training on Exercise Performance and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- changes in exercise performance
研究概览
简要总结
The aim is to study effectiveness of inspiratory muscle training as a part of exercise training in patients with Chronic Obstructive Pulmonary Disease (COPD) and if it adds to general exercise training program in regard to respiratory muscle strength, dyspnea, exercise performance and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Exsmokers
- •Low PImax compared to reference values [lower limits of normal: 80 cmH2O for patients less than or equal 54 years old; 71 cmH2O for patients' age between 55-64 years; and 65 cmH2O for patients 65 years old ].
- •Stable patients without history of exacerbation or hospitalization four weeks before starting the study.
排除标准
- •Lack of motivation and compliance.
- •Patients with significant reversibility following bronchodilation defined as an increase in FEV1 of more than 12% and 200 ml from the pre-bronchodilator value
- •Unstable cardiac disease [severe heart failure, dangerous dysrhythmias, recent myocardial infarction or unstable angina (within 4 weeks)].
- •Uncontrolled hypertension
- •Recent pneumothorax (within 6 weeks)
- •Recent abdominal or thoracic surgery (within 6 weeks)
- •Known progressive neuromuscular disorders
- •Recent gastrointestinal bleeding (within 4 weeks)
- •Current smokers
- •Active cancer
- •Patients with advanced liver diseases, or renal impairment.
- •Known connective tissue diseases
- •Significant endocrinal abnormalities
研究组 & 干预措施
Study group (group A)
pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations peripheral muscles exercise training: (upper limb and lower limb strength and endurance training) inspiratory muscle training: (at intensity that progressively increased from 30% to 60% of patients' maximal inspiratory pressure)
干预措施: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations (Drug)
Study group (group A)
pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations peripheral muscles exercise training: (upper limb and lower limb strength and endurance training) inspiratory muscle training: (at intensity that progressively increased from 30% to 60% of patients' maximal inspiratory pressure)
干预措施: peripheral muscles exercise training (Other)
Study group (group A)
pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations peripheral muscles exercise training: (upper limb and lower limb strength and endurance training) inspiratory muscle training: (at intensity that progressively increased from 30% to 60% of patients' maximal inspiratory pressure)
干预措施: inspiratory muscle training (Device)
control positive group (group B)
pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations peripheral muscles exercise training: (upper limb and lower limb strength and endurance training)
干预措施: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations (Drug)
control positive group (group B)
pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations peripheral muscles exercise training: (upper limb and lower limb strength and endurance training)
干预措施: peripheral muscles exercise training (Other)
control negative group (group C)
pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations
干预措施: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations (Drug)
结局指标
主要结局
changes in exercise performance
时间窗: after 4 weeks and after 8 weeks of study
6-min walk test
changes in quality of life
时间窗: after 4 weeks and after 8 weeks of study
BODE index, St. George's Respiratory Questionnaire for COPD patients (SGRQ-C)
changes in respiratory muscle strength
时间窗: after 4 weeks and after 8 weeks of study
maximal inspiratory pressure, maximal expiratory pressure
changes in perception of dyspnea
时间窗: after 4 weeks and after 8 weeks of study
modified Medical Research Council and modified Borg category scale
次要结局
未报告次要终点
研究者
Dina Aboelkhair Abdallah
assistant lecturer in chest medicine
Mansoura University