Freitas Patricia D, Ferreira Palmira G, da Silva Analuci, Trecco Sonia, Stelmach Rafael, Cukier Alberto, Carvalho-Pinto Regina, Salge João Marcos, Fernandes Frederico L A, Mancini Marcio C, Martins Milton A, Carvalho Celso R F
Department of Physical Therapy, University of São Paulo, Av. Dr. Arnaldo 455, Rm 1210, São Paulo, SP, 01246-903, Brazil.
Department of Psychology, University of São Paulo, Sao Paulo, Brazil.
BMC Pulm Med. 2015 Oct 21;15:124. doi: 10.1186/s12890-015-0111-2.
Asthma and obesity are public health problems with increasing prevalence worldwide. Clinical and epidemiologic studies have demonstrated that obese asthmatics have worse clinical control and health related quality of life (HRQL) despite an optimized medical treatment. Bariatric surgery is successful to weight-loss and improves asthma control; however, the benefits of nonsurgical interventions remain unknown.
METHODS/DESIGN: This is a randomized controlled trial with 2-arms parallel. Fifty-five moderate or severe asthmatics with grade II obesity (BMI ≥ 35 kg/m(2)) under optimized medication will be randomly assigned into either weight-loss program + sham (WL + S group) or weight-loss program + exercise (WL + E group). The weight loss program will be the same for both groups including nutrition and psychological therapies (every 15 days, total of 6 sessions, 60 min each). Exercise program will include aerobic and resistance muscle training while sham treatment will include a breathing and stretching program (both programs twice a week, 3 months, 60 min each session). The primary outcome variable will be asthma clinical control. Secondary outcomes include HRQL, levels of depression and anxiety, lung function, daily life physical activity, body composition, maximal aerobic capacity, strength muscle and sleep disorders. Potential mechanism (changes in lung mechanical and airway/systemic inflammation) will also be examined to explain the benefits in both groups.
This study will bring a significant contribution to the literature evaluating the effects of exercise conditioning in a weight loss intervention in obese asthmatics as well as will evaluate possible involved mechanisms.
NCT02188940.
哮喘和肥胖是全球患病率不断上升的公共卫生问题。临床和流行病学研究表明，尽管进行了优化的药物治疗，但肥胖哮喘患者的临床控制和健康相关生活质量（HRQL）仍较差。减肥手术在减肥方面取得成功并改善了哮喘控制；然而，非手术干预的益处仍不明确。
方法/设计：这是一项双臂平行的随机对照试验。55名在优化药物治疗下的中度或重度肥胖（BMI≥35kg/m²）哮喘患者将被随机分为减肥计划+假治疗组（WL+S组）或减肥计划+运动组（WL+E组）。两组的减肥计划相同，包括营养和心理治疗（每15天一次，共6次，每次60分钟）。运动计划将包括有氧运动和抗阻肌肉训练，而假治疗将包括呼吸和伸展计划（两个计划均为每周两次，为期3个月，每次60分钟）。主要结局变量将是哮喘临床控制。次要结局包括HRQL、抑郁和焦虑水平、肺功能、日常生活体力活动、身体成分、最大有氧能力（心肺耐力）、肌肉力量和睡眠障碍。还将研究潜在机制（肺力学和气道/全身炎症的变化）以解释两组的益处。
本研究将为评估运动调节在肥胖哮喘患者减肥干预中的效果的文献做出重大贡献，并将评估可能涉及的机制。
NCT02188940。
