Effects of Exercise Training in a Weight-loss Lifestyle Intervention on Clinical Control and Psychosocial Morbidity in Obese Asthmatics: a Randomized and Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Clinical Control
研究概览
简要总结
Obese asthmatics have more severe symptoms, reduced lung function, poorer quality of life and a reduced response to inhaled corticosteroid medication compared to non-obese asthmatics. In addition, the impact of a weight-loss program on clinical control and psychological outcomes has been poorly demonstrated and the effect of exercise training remain unknown. The investigators aim to investigate the effect of exercise training in a weight-loss program on asthma clinical control (primary outcome), health factors related to quality of life and psychosocial symptoms (secondary outcomes) in obese patients with moderate-to-severe persistent asthma. Physical activity, inflammatory profiles and sleep disorders will also be evaluated. The investigators' hypothesis is that exercise as part of a weight-loss program is more effective to lose weight and improve asthma control, quality of life and psychosocial symptoms in obese asthmatics.
详细描述
This is a randomized, controlled and single blinded trial. Fifty-four asthmatic adults will be randomly assigned into two groups: DBG (dietary and behavioral support group) or DBE (similar to DBG + exercise training). Both groups will complete a weight-loss program based on dietary and behavioral therapy. In addition, DBE will perform a training program based on aerobic and resistance training whereas DBG will perform a breathing and stretching program. Interventions will be performed twice a week for 3 months, 60 minutes each. 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 Bonferroni. 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)
入排标准
- 年龄范围
- 30 Years 至 60 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)
- •Body Mass Index between 35 kg/ m2 and 39,9 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
- •Cardiovascular, musculoskeletal or other chronic lung diseases
- •Active Cancer
- •Weight loss more than 5 % in the preceding 6 months
- •Using weight-loss medications
- •History of bariatric surgery, uncontrolled hypertension or diabetes
- •Using overnight continuous positive airway pressure
- •Lactating
- •Current or ex-smoker
结局指标
主要结局
Clinical Control
时间窗: Before and after 3 months of intervention
Clinical control will be evaluated by asthma control questionnaire (ACQ)
次要结局
- Health related quality of life(Before and after 3 months of intervention)
- Level of depression and anxiety(Before and after 3 months of intervention)