Effectiveness of a Physical Training Program on Inflammatory Response, Functional Capacity and Quality Life in Children With Moderate and Severe Asthma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Inflammatory mediators by analyzing cytokines by flow cytometry
研究概览
简要总结
Regular aerobic physical activity in short-term moderate asthma and severe:
- Reduce the levels of inflammatory mediators
- Improves functional capacity
- Improves Quality of Life
- Improved lung function
- Reduces the sensation of dyspnea
- Improves symptoms scores and medication use
详细描述
Methods: Is designed a randomized clinical trial, efficacy, outpatient physical therapy developed in the Institute of Integrative Medicine Teacher Fernando Figueira (IMIP). A pilot study with 20 participants will be made initially to obtain a sample calculation. Subjectively estimated it will take about 50 participants, with possible losses. Will include children older than eight years, diagnosis of moderate and severe persistent asthma according to criteria of Global Initiative National Asthma (GINA) and forced expiratory volume in one minute (FEV1) below 80% predicted. Will be excluded from the study associated with disease that limits physical activity, such as neuromuscular diseases, congenital or acquired heart disease, chronic lung disease associated exacerbation of the crisis and significant cognitive deficit, which makes the participant to respond adequately to the questionnaire and / or inability to meet the commands. Eligible patients will be randomized into two groups: control group, which is not subjected to any kind of exercise and the intervention group, which will be submitted to aerobic exercise for 30 minutes three times a week for six weeks. The two groups will be evaluated before and at the end of six weeks by testing for 6-minute walk, analysis of dyspnea, questionnaire of quality of life, pulmonary function test (FEV1, FVC), inflammatory markers (cytokine ).
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
- 8 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than eight and less than nineteen years
- •Diagnosis of moderate to severe persistent asthma according to criteria of GINA
- •forced expiratory volume in one minute (FEV1) below 80% of predicts
- •Initiation of treatment with inhaled corticosteroids for at least eight weeks before the start of collection.
排除标准
- •associated disease that limits physical activity, such as neuromuscular disease, congenital or acquired, severe cor pulmonate, severe congenital malformation
- •associated with chronic lung disease (cystic fibrosis, bronchiectasis, bronchopulmonary dysplasia, interstitial lung diseases
- •significant cognitive deficit, which makes the participant to respond adequately to the questionnaire and / or failure to meet the commands
- •exacerbation of crisis (This will be a temporary exclusion criterion, as having taken action as directed by medical routine, the participant can return to training)
- •mental deficit.
结局指标
主要结局
Inflammatory mediators by analyzing cytokines by flow cytometry
时间窗: six weeks
Was carried collection of peripheral blood cells separated and analyzed for cytokine flow cytometry method. We evaluated Th1 and Th2 cytokines.
次要结局
- Analysis of cytokines(Before and after 6 weeks)
- Days free of asthma(After six weeks)
- Distance walked during the 6-minute walk(6 weeks)
- Respiratory pressures maxima(Before and after 6 weeks)
- Changes in lung function(Before and after 6 weeks of intervention)
研究者
Livia Barboza de Andrade
PhD Student
Instituto Materno Infantil Prof. Fernando Figueira