Effect of Aerobic Training on Bronchial Hyperresponsiveness and Systemic Inflammation in Patients With Moderate or Severe Asthma: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Bronchial hyperresponsiveness
研究概览
简要总结
Exercise training has been proposed as adjunctive therapy in asthma to improve many clinical outcomes; however its effects on bronchial hyperresponsiveness (BHR) and inflammation, characteristic features in asthma, remains poorly understood. We aim to investigate the effects of aerobic training on BHR (primary aim) and systemic inflammation (secondary aim). In addition, clinical control and health related quality of life (HRQoL) will be also assessed.
详细描述
This is a randomized, controlled and single-blind trial whose intervention will be an aerobic training. Fifty -eight patients with moderate or severe persistent asthma will be recruited at a university hospital and randomly assigned in two groups: control (CG) or training (TG) .The study will be performed between two medical visits with intervals of six months and during this period the same medication dosage will be maintained. Patients in CG will perform (an educational program + breathing exercise; n=28) and TG patients will perform (an educational program+breathing exercises+aerobic training; n=30).The sessions will be conducted twice a week, for 3 months. Before and after the intervention, all patients will be evaluated by bronchial hyperresponsiveness, serum cytokines levels, total immunoglobulin E, induced sputum, fractional exhaled nitric oxide (FeNO), asthma clinical control (daily symptoms dairy, exacerbations and asthma control questionnaire - ACQ), health related quality of life (HRQoL); asthma quality of life questionnaire-(AQLQ), pulmonary function and cardiopulmonary exercise testing. All the patients will be evaluated by specific immunoglobulin E (atopy) through (skin prick test or Phadiatop).
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 (Investigator)
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
- •Patients with moderate and severe persistent asthma
- •Asthma will diagnosed according to Global Initiative for Asthma (GINA)
- •Body Mass Index <35 kg/ m2
- •Patients will submitted the medical treatment, followed by pulmonary specialists for at least 6 months.
- •Patients will considered clinically stable (i.e., no exacerbation or changes in medication for at least 30 days).
排除标准
- •Patients will diagnosed with cardiovascular, musculoskeletal or other chronic lung diseases;
- •Patients with current participation in exercise programs
- •current smokers or ex-smokers will excluded from the study.
结局指标
主要结局
Bronchial hyperresponsiveness
时间窗: Before and after 3 months of intervetion
The bronchial provocation test will be conducted according to American Thoracic Society (ATS) guideline (1999). Patients will inhale increasing concentrations of histamine following the sequences: 0.0625, 0.25, 1.0, 4.0 and 16.0 mg/ ml using the method of the dosimeter (DeVilbiss 646nebulizer, DeVilbiss Health Care, USA) . Forced expiratory volume in one second (FEV1) will be measured after 30 and 90 seconds from the end of inhalations. The test will considered positive when the concentration of histamine promotes a fall ≥ 20% in FEV1 (PC20) with respect to the post-saline value or when the maximum concentration is reached (16 mg/mL).
次要结局
- serum cytokines levels(Before and after 3 months of intervention)