Hansen Erik Sören Halvard, Hostrup Morten, Rasmusen Hanne Kruuse, Hellsten Ylva, Backer Vibeke
Centre for Physical Activity Research, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.
BMJ Open. 2021 Apr 22;11(4):e049477. doi: 10.1136/bmjopen-2021-049477.
Late-onset asthma in postmenopausal women is characterised by poor disease control with daily symptoms and reduced quality of life despite treatment with inhaled antiasthma therapies. These patients represent a phenotype that is characterised by low eosinophilic airway inflammation, severe symptoms, moderate obesity and poor response to inhaled antiasthma therapies, which highlights the need of identification of alternative treatment strategies. Thus, this study aims to evaluate if regular high-intensity aerobic exercise improves symptom control in postmenopausal women with asthma.
This is an ongoing randomised controlled trial planning to enrol 40 postmenopausal women with late-onset asthma. Participants are randomised 1:1 either to supervised exercise training (spinning) three times per week for 12 weeks or to usual care. The primary outcome is change from baseline to follow-up in the Asthma Control Questionnaire. Secondary outcomes are changes in markers of systemic inflammation, airway inflammation, body composition and right ventricular function of the heart.
The study is approved by the Ethics Committee in the Capital Region of Denmark nr. H-18028966 and the Danish Data Protection Agency nr. VD-2019-59. The methods used in the study are well known and have a low risk with a chance of substantial improvement in disease control in this patient group. Results are planned to be published in an international peer-reviewed medical journal regardless of outcome.
NCT03747211.
绝经后女性迟发性哮喘的特点是疾病控制不佳，尽管使用吸入性抗哮喘疗法治疗，但仍有日常症状且生活质量下降。这些患者代表了一种表型，其特征为嗜酸性粒细胞气道炎症水平低、症状严重、中度肥胖以及对吸入性抗哮喘疗法反应不佳，这凸显了确定替代治疗策略的必要性。因此，本研究旨在评估定期进行高强度有氧运动是否能改善绝经后哮喘女性的症状控制。
这是一项正在进行的随机对照试验，计划招募40名绝经后迟发性哮喘女性。参与者按1:1随机分组，一组每周接受3次、为期12周的有监督的运动训练（动感单车），另一组接受常规护理。主要结局指标是哮喘控制问卷从基线到随访的变化。次要结局指标是全身炎症、气道炎症、身体成分和心脏右心室功能标志物的变化。
该研究已获得丹麦首都地区伦理委员会（编号H-18028966）和丹麦数据保护局（编号VD-2019-59）的批准。本研究中使用的方法广为人知，风险较低，且有机会显著改善该患者群体的疾病控制情况。无论结果如何，计划将研究结果发表在国际同行评审的医学期刊上。
NCT03747211。
