Liu Xiaodan, Li Peijun, Xiao Lu, Lu Yufan, Li Ning, Wang Zhengrong, Duan Hongxia, Li Jian, Wu Weibing
School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Institute of Rehabilitation Medicine, Shanghai Academy of Traditional Chinese Medicine, Shanghai, China.
Trials. 2019 Jan 11;20(1):41. doi: 10.1186/s13063-018-3149-7.
Chronic obstructive pulmonary disease (COPD) not only affects pulmonary function but also leads to skeletal muscle dysfunction. The various characteristics of different forms of traditional Chinese exercise lead to inconsistent clinical effects in COPD patients. Hence, the present study carefully combined and rearranged liuzijue, wuqinxi, baduanjin, and yijinjing into a pulmonary exercise program targeting COPD patients.
METHODS/DESIGN: This study is a single-blind, randomized controlled trial. A random number table will be generated by an independent person. Each number will be placed in a sealed opaque envelop to blind assignment. All outcome assessors will be blinded to group assignment. COPD patients between 40 and 80 years of age, with stable medical treatment and no regular participation in regular exercise in the last 6 months will be included. All participants will be recruited from the Respiratory Medicine Department of Yue-Yang Integrative Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine. All participants will continue to follow their medical treatment. They will be randomly assigned to one of four groups in a 1:1:1:1 ratio: (1) usual care (control group, CG), (2) pulmonary exercise group (PG), (3) resistance exercise group (RG), or (4) combined pulmonary exercise and resistance exercise group (PRG). CG participants will receive medical treatment only. PG participants will perform 60 min of exercise twice a day 7 days a week for 3 months, with 1 day's exercise per week at hospital under guidance and supervision. RG participants will perform 60 min of resistance exercise once a day, three times a week for 3 months, with 1 day's exercise per week at hospital under guidance and supervision. PRG participants will perform 60 min of prescribed pulmonary exercise combined with resistance exercise for 3 months. The outcomes include the isokinetic strength of peripheral skeletal muscle, surface electromyography, 6-min walking distance, 30-s arm curl test, pulmonary function, respiratory muscle strength, dyspnea, body composition, physical activity, quality of life, and Chronic Disease Self-Efficacy Scale.
The results of this study will compensate for the current inadequate understanding of prescribed pulmonary exercise and may provide a new, simple, convenient, and effective home-based exercise intervention for COPD patients.
Chinese Clinical Trial Registry, ChiCTR-1800017405 . Registered on 28 July 2018.
慢性阻塞性肺疾病（COPD）不仅影响肺功能，还会导致骨骼肌功能障碍。不同形式的传统中医运动的各种特点导致COPD患者的临床效果不一致。因此，本研究精心将六字诀、五禽戏、八段锦和易筋经组合并重新编排成一个针对COPD患者的肺部运动方案。
方法/设计：本研究为单盲随机对照试验。由独立人员生成随机数字表。每个数字将被放入密封的不透明信封中进行盲法分配。所有结果评估者将对分组情况不知情。纳入年龄在40至80岁之间、病情稳定且在过去6个月内未定期参加规律运动的COPD患者。所有参与者将从上海中医药大学附属岳阳中西医结合医院呼吸内科招募。所有参与者将继续接受他们的常规治疗。他们将按1:1:1:1的比例随机分配到四组之一：（1）常规护理（对照组，CG），（2）肺部运动组（PG），（3）抗阻运动组（RG），或（4）肺部运动与抗阻运动联合组（PRG）。CG组参与者仅接受常规治疗。PG组参与者将每周7天，每天进行2次60分钟的运动，持续3个月，每周有1天在医院的指导和监督下进行运动。RG组参与者将每周进行3次，每次60分钟的抗阻运动，持续3个月，每周有1天在医院的指导和监督下进行运动。PRG组参与者将进行3个月规定的肺部运动与抗阻运动相结合的运动。结果包括外周骨骼肌等速肌力、表面肌电图、6分钟步行距离、30秒臂弯举试验、肺功能、呼吸肌力量、呼吸困难、身体成分、身体活动、生活质量和慢性病自我效能量表。
本研究结果将弥补目前对规定的肺部运动认识不足的问题，并可能为COPD患者提供一种新的、简单、方便且有效的居家运动干预方法。
中国临床试验注册中心，ChiCTR-1800017405。于2018年7月28日注册。
