Effects of Aerobic and Respiratory Exercises on Asthma Clinical Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in asthma clinical control
研究概览
简要总结
Many studies have reported the benefits of aerobic and breathing exercises such as, reduction of symptoms and reduced the use of medications, the number of crises, exercise induced bronchoconstriction (EIB), and improvement in health-related quality of life (HRQoL). This study will be a randomized and controlled trial (RCT) with 2 parallel arms and blinded assessment. Fifty-four moderate or severe patients with asthma under optimized medication will be randomly assigned (computer-generated) into either aerobic+breathing exercises (AB) or aerobic+stretching exercises (AS). All patients will receive the same educational session and will perform the physical exercise proposed for the group for 12 weeks, 2 times/week, 60-minute sessions; however, the AB group will perform Buteyko breathing technique and AS will perform muscle stretching exercise. All patients will be assessed to clinical control, quality of life, psychosocial symptoms, pulmonary function, functional capacity, physical activity levels, sleep quality, thoracoabdominal mechanics, hyperventilation symptoms, and asthma exacerbation. The data normality will be analyzed by Kolmogorov-Smirnov. The variables obtained before interventions will be compared using the t-test or Mann-Whitney U-test. Comparisons of the outcomes initial and final data will be analyzed with repeated measures ANOVA with appropriate post hoc test. The significance level will be set to 5% for all tests.
详细描述
Many studies have reported the benefits of aerobic and breathing exercises such as, reduction of symptoms and reduced the use of medications, the number of crises, exercise induced bronchoconstriction (EIB), and improvement in health-related quality of life (HRQoL). This study will be a randomized and controlled trial (RCT) with 2 parallel arms and blinded assessment. Fifty-four moderate or severe patients with asthma under optimized medication will be randomly assigned (computer-generated) into either aerobic+breathing exercises (AB) or aerobic+stretching exercises (AS). All patients will receive the same educational session and will perform the physical exercise proposed for the group for 12 weeks, 2 times/week, 60-minute sessions; however, the AB group will perform Buteyko breathing technique and AS will perform muscle stretching exercise. All patients will be assessed to clinical control, quality of life, psychosocial symptoms, pulmonary function, functional capacity, physical activity levels, sleep quality, thoracoabdominal mechanics, hyperventilation symptoms, and asthma exacerbation. The data normality will be analyzed by Kolmogorov-Smirnov. The variables obtained before interventions will be compared using the t-test or Mann-Whitney U-test. Comparisons of the outcomes initial and final data will be analyzed with repeated measures ANOVA with appropriate post hoc test. The significance level will be set to 5% for all tests.
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)
盲法说明
All the measurements will be performed by a professional blinded to the groups. The same assessor will be maintained to perform the evaluations before and after the intervention. The professionals involved with the evaluations will be different from the professionals involved on the intervention.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthma moderate and severe with diagnosed according to the Global Initiative for Asthma (GINA) 2020
- •Sedentary (< 150 min of moderate to vigorous physical activity/week)
- •Body Mass Index ≥18.5 kg/m2 and <35 kg/m2
- •Medical treatment, for at least 6 months
- •Clinically stable (i.e., no exacerbation or changes in medication for at least 30 days)
排除标准
- •Cardiovascular, musculoskeletal or other chronic lung diseases
- •Active Cancer
- •Uncontrolled hypertension or diabetes
- •Current smoker or ex smoker (>10 pack-years)
- •Psychiatric disease or cognitive deficit
结局指标
主要结局
Change in asthma clinical control
时间窗: Change from baseline to 10 weeks of intervention
Clinical control will be evaluated by the Asthma Control Questionnaire (ACQ). The ACQ contains 7 items rated on a 7-point scale (0 = without limitation, 6 = maximum limitation), with a higher score indicating worse control. Scores lower than 0.75 are associated with good asthma control, whereas scores greater than 1.5 are indicative of poorly controlled asthma, and a change of at least 0.5 points in the ACQ score is regarded as clinically significant.
次要结局
- Change in pulmonary function in absolute values(Change from baseline to 10 weeks of intervention)
- Change in sleep quality(Change from baseline to 10 weeks of intervention)
- Change in asthma exacerbation(Change from baseline to 10 weeks of intervention)
- Change in health related quality of life(Change from baseline to 10 weeks of intervention)
- Change in pulmonary function in predict values(Change from baseline to 10 weeks of intervention)
- Change in psychosocial symptoms(Change from baseline to 10 weeks of intervention)
- Change in functional capacity(Change from baseline to 10 weeks of intervention)
- Change in physical activity levels(Change from baseline to 10 weeks of intervention)
- Change in thoracoabdominal mechanics(Change from baseline to 10 weeks of intervention)
- Change in hyperventilation symptoms(Change from baseline to 10 weeks of intervention)