The Effects of an Exercise Program With Pilates Method on Quality of Life and Clinical Control in Asthmatic Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in health related quality of life
研究概览
简要总结
Asthma is a chronic respiratory disease with high prevalence worldwide, considered an important cause of morbidity, mortality and high economic costs. Aerobic physical exercise has great merit as non-pharmacological treatment and other exercise modalities have being studied. However, there are few data in the literature about the effects of Pilates method in patients with asthma. The objective of this study is evaluate the effects of a program of exercise using Pilates on health factors related to quality of life in patients with moderate or severe persistent asthma. Patients will be also evaluated about disease control, anxiety and depression symptoms, functional capacity, lung function, respiratory muscle strength, thoracoabdominal mechanics and level of daily life physical activity. The investigators' hypothesis is that strengthening of the deep trunk muscles promotes a mechanical fixation of the thorax, contributing to the clinical improvement of patients with asthma.
详细描述
This is a randomized, controlled and single blinded trial. Thirty adults with moderate or severe persistent asthma will be randomly assigned into two groups: Pilates method - PM (training group) or muscle stretching exercises - MSE (control group). All subjects will receive the same educational session and will perform the physical exercise proposed for the group for 12 weeks, 3 times/week, 40-minute sessions. The data normality will be analyzed by Kolmogorov-Smirnov, the variables obtained before interventions will be compared with the Student t-test or Mann-Whitney U-test. Comparisons of the initial and final data on outcomes will be analyzed with repeated measures ANOVA with appropriate post hoc of Holm-Sidak. 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 blinded professional, who will be masked from randomization and other results. For each test, the same investigator will be maintained before and after the intervention. The participants will know what treatment (exercise) they will receive, but they don't will know what exercise belongs to the control group.
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthma moderate and severe
- •Asthma will diagnosed (Global Initiative for Asthma -GINA)
- •Asthma medication according recommendations from GINA
- •Body Mass Index ≥18.5 kg/m2 and <35 kg/m2
- •Sedentary
- •Medical treatment, for at least 6 months
- •Clinically stable (i.e., no exacerbation or medication changes for at least 30 days)
排除标准
- •Current or ex-smokers (who have given up smoking less than 1 year and/or tobacco charge greater than 10 pack-years)
- •Cardiovascular, musculoskeletal and other chronic lung diseases
- •Active cancer
- •Uncontrolled hypertension or diabetes
- •Continuous use of oral corticosteroid
- •Psychiatric disease or cognitive deficit
研究组 & 干预措施
Pilates Method
The intervention of active comparator will be Pilates Method exercises.
干预措施: Pilates (Other)
Muscle stretching exercises
The intervention of sham comparator will be muscle stretching exercises.
干预措施: Muscle stretching (Other)
结局指标
主要结局
Change in health related quality of life
时间窗: Change from baseline after 3 months of intervention
Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ). The AQLQ is composed by 32 items rated on a 7-point scale ranging from 7 = without limitation to 1 = maximum limitation and grouped in 4 domains: activity limitations (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). Total score will be obtained by the average of the 32 items. The score of each domain will be obtained by the average of the items that compose the domain. A higher score indicates a better quality of life in relation asthma disease and a minimal important difference of 0.5 points results in clinically improvement or deterioration for total score and for each domain.
次要结局
- Change in daily life physical activity(Change from baseline after 3 months of intervention)
- Change in clinical control(Change from baseline after 3 months of intervention)
- Change in the level of anxiety and depression(Change from baseline after 3 months of intervention)
- Change in thoracoabdominal mechanics(Change from baseline after 3 months of intervention)
- Change in respiratory muscle strength(Change from baseline after 3 months of intervention)
- Change in pulmonary function(Change from baseline after 3 months of intervention)
- Change in functional capacity(Change from baseline after 3 months of intervention)