Montreal Behavioural Medicine Centre, Hôpital du Sacré-Coeur de Montréal-a University of Montreal Affiliated Hospital, Montreal, Quebec, Canada.
BMJ Open. 2013 Jun 20;3(6):e003177. doi: 10.1136/bmjopen-2013-003177.
Aerobic exercise can improve cardiovascular fitness and does not seem to be detrimental to patients with asthma, though its role in changing asthma control and inflammatory profiles is unclear. The main hypothesis of the current randomised controlled trial is that aerobic exercise will be superior to usual care in improving asthma control. Key secondary outcomes are asthma quality of life and inflammatory profiles.
A total of 104 sedentary adults with physician-diagnosed asthma will be recruited. Eligible participants will undergo a series of baseline assessments including: the asthma control questionnaire; the asthma quality-of-life questionnaire and the inflammatory profile (assessed from both the blood and sputum samples). On completion of the assessments, participants will be randomised (1:1 allocation) to either 12-weeks of usual care or usual care plus aerobic exercise. Aerobic exercise will consist of three supervised training sessions per week. Each session will consist of taking a short-acting bronchodilator, 10 min of warm-up, 40 min of aerobic exercise (50-75% of heart rate reserve for weeks 1-4, then 70-85% for weeks 5-12) and a 10 min cool-down. Within 1 week of completion, participants will be reassessed (same battery as at baseline). Analyses will assess the difference between the two intervention arms on postintervention levels of asthma control, quality of life and inflammation, adjusting for age, baseline inhaled corticosteroid prescription, body weight change and pretreatment dependent variable level. Missing data will be handled using standard multiple imputation techniques.
The study has been approved by all relevant research ethics boards. Written consent will be obtained from all participants who will be able to withdraw at any time.
The result will be disseminated to three groups of stakeholder groups: (1) the scientific and professional community; (2) the research participants and (3) the general public.
NCT00953342.
有氧运动可以改善心血管健康，似乎对哮喘患者也没有危害，尽管其在改变哮喘控制和炎症特征方面的作用尚不清楚。本随机对照试验的主要假设是，与常规护理相比，有氧运动将更有效地改善哮喘控制。主要次要结局是哮喘生活质量和炎症特征。
共招募 104 名久坐的、经医生诊断的哮喘成年人。合格的参与者将接受一系列基线评估，包括：哮喘控制问卷；哮喘生活质量问卷和炎症特征（通过血液和痰样评估）。完成评估后，参与者将被随机（1:1 分配）分配到 12 周的常规护理或常规护理加有氧运动。有氧运动将包括每周三次监督训练。每个疗程包括使用短效支气管扩张剂、10 分钟热身、40 分钟有氧运动（第 1-4 周心率储备的 50-75%，第 5-12 周为 70-85%）和 10 分钟冷却。在完成后的 1 周内，参与者将重新评估（与基线相同的评估）。分析将评估两种干预措施在哮喘控制、生活质量和炎症的干预后水平上的差异，同时调整年龄、基线吸入皮质类固醇处方、体重变化和预处理因变量水平。将使用标准的多重插补技术处理缺失数据。
该研究已获得所有相关研究伦理委员会的批准。所有参与者都将获得书面同意，他们可以随时退出。
结果将分发给三组利益相关者群体：（1）科学界和专业界；（2）研究参与者；（3）公众。
注册详情 CLINICALTRIALSGOV 标识符：NCT00953342。
