REPLACE: Can Exercise Replace Inhaled Corticosteroid Treatment in Asthma? A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Reduced inhaled corticosteroid (ICS) 6 months
研究概览
简要总结
To evaluate if physical exercise intervention leads to an improved asthma control as measured by Asthma Control Questionnaire (ACQ-5) in such a magnitude that inhaled corticosteroid can be reduces in asthmatics.
详细描述
At least 102 asthmatics will be randomized 2:1 (2 to training group; 1 to control) and undergo 6 months of intervention or usual lifestyle.
Subjects must have confirmed asthma diagnosis, on a stable treatment with inhaled corticosteroid, symptomatic and untrained.
At enrollment and during the study asthma medicine is adjusted based on asthma symptoms evaluated by ACQ-5. 6 treatment steps are pre-defined, and if well controlled asthma, subjects are down-titrated one step, if uncontrolled, subjects are uptitrated one step.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Single blindet, randomization and training intervention by non-investigator. Open-label after primary follow up. After unblinding, blindet 3rd party performs tests (visit 9 and 12 months, e.g. spirometry)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthma (The diagnose of asthma is based on symptoms and at least one positive asthma test the last 5 years (AHR to either mannitol or methacholine, reversibility to beta2-agonist, peak flow variation or positive eucapnic voluntary hyperventilation test))
- •ACQ ≥ 1 and ≤ 2.5
- •On a daily dose of ICS at a minimum of 400 µg budesonide or equivalent ICS for 3 months and with no changes in asthma medicine 4 weeks prior to enrollment
- •Untrained (no participation in vigorous exercise for more than 1 hour per week during the last 2 month)
- •Capable of exercising on bike
排除标准
- •Unable to speak and understand Danish
- •Infection within 4 weeks prior to visit 100*
- •Asthma exacerbation within 4 weeks prior to visit 100*
- •Hospitalized for an asthma attack during the last 2 months
- •Treatment with immunotherapy within 5 T½ of the treatment drug prior to visit 100
- •Initiation of allergen immunotherapy within 3 months prior to visit 100 or plan to begin therapy during study period
- •Treatment with peroral prednisolone
- •Respiratory: other chronic pulmonary disease of clinically significance
- •Cardiovascular: Unstable ischemic heart disease, myocardial infarction within the last 12 months, symptomatic heart failure (NYHA III-IV or EF <40%), symptomatic heart arrhythmia (documented with ECG), uncontrolled hypertension (>155/100)
- •Pregnancy or breastfeeding or planned pregnancy within the next 12 months
- •Other inflammatory or metabolic diseases with the exception of rhinitis, atopy and well-controlled hypothyroidism treated with or without Eltroxin
- •Vaccination less than 2 weeks prior to any visit
- •Current or former smokers with > 20 pack years
- •Subjects, who by investigators determination, will not be able to adhere to study protocol
- •If patients are excluded due to a recent infection or exacerbation they can undergo re-screening after a total of 4 weeks after end of exacerbation treatment/clearing the infection.
研究组 & 干预措施
Training group
Supervised High intensity interval training (HIIT) 3 times a week for 6 months.
Training session:
10 minutes warm up (Low-moderate intensity) 30 minutes intervention (16 minutes HIIT) 10 minutes cool down(Low-moderate intensity)
干预措施: High Intensity Interval Training (Behavioral)
Control group
Control group, usual lifestyle. Aside from training intervention, all other visits are the same as intervention group (training).
结局指标
主要结局
Reduced inhaled corticosteroid (ICS) 6 months
时间窗: 6 months +/- 7 days
The proportion of participants at 6 months that have been down-titrated in ICS dose by at least 25% compared to the participants' baseline dose
次要结局
- Cumulated LABA 12 months(12 months +/- 7 days)
- miniAQLQ 12 months(12 months +/- 7 days)
- Sputum cell count 6 months(6 months +/- 7 days)
- FVC 12 months(12 months +/- 7 days)
- Reduced inhaled corticosteroid (ICS) 12 months(12 months +/- 7 days)
- Cumulated ICS 12 months(12 months +/- 7 days)
- Exacerbation rate 6 months(6 months +/- 7 days)
- miniAQLQ 6 months(6 months +/- 7 days)
- Fraction of exhaled Nitrogen Oxid 6 months(6 months +/- 7 days)
- Sputum cell count 12 months(12 months +/- 7 days)
- Cumulated ICS 6 months(6 months +/- 7 days)
- Cumulated Long acting beta2 agonists (LABA) 6 months(6 months +/- 7 days)
- Exacerbation rate 12 months(12 months +/- 7 days)
- Fraction of exhaled Nitrogen Oxid 12 months(12 months +/- 7 days)
- FEV1 6 months(6 months +/- 7 days)
- FEV1 12 months(12 months +/- 7 days)
- Systemic inflammation 12 months(12 months +/- 7 days)
- Airway hyperresponsiveness(6 months +/- 7 days)
- Cardiopulmonary fitness(6 months +/- 7 days)
- Change in fat and muscle composition (DEXA scan)(6 months +/- 7 days)
- Systemic inflammation 6 months(6 months +/- 7 days)
- FVC 6 months(6 months +/- 7 days)
研究者
Vibeke Backer
Professor dr.med.
Bispebjerg Hospital