Yu Wei, Su Peiyuan, Wang Jiaojiao, Zhou Pengcheng, Chen Keling, Liu Li, Xia Qianming, Chen Yuewei
Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.
Department of Cardiothoracic Surgery, Hospital of Chengdu University of Traditional Chinese Medicine.
Medicine (Baltimore). 2020 Jun 5;99(23):e20625. doi: 10.1097/MD.0000000000020625.
Chronic obstructive pulmonary disease (COPD) is a common high-burden and highly disabling lung disease. The quality of life and exercise endurance of patients with COPD is often low because of atrophy of the respiratory and skeletal muscles. Although recommended by the global initiative for chronic obstructive lung disease guidelines, pulmonary rehabilitation (PR) has not been used widely because of its inherent limitations. Tuna-Hui-Chun-Gong (TNHCG) is a popular traditional exercise used to treat COPD in China. We aim to evaluate the safety and efficacy of TNHCG for PR of COPD.
The provided protocol is for a single-blind randomized controlled trial in which 120 COPD patients will be randomly and equally divided into the experimental or control group. The control group will be treated with standard COPD drugs while the experimental group will perform TNHCG exercises apart from standard drug treatment. The duration of treatment will be 24 weeks and a follow-up for 48 weeks. The primary outcome will be the 6-Minute Walk Test. The secondary outcomes will include the pulmonary function test, St George's respiratory questionnaire, COPD assessment test, modified medical research council dyspnea scale, Hospital Anxiety and Depression Scale, and exacerbation frequency. A safety assessment will also be performed during the trial.
Our study will provide evidence to support TNHCG exercise as an additional measure for PR of COPD.
ChiCTR1900028332, Registered December 29, 2019.
Ethics approval has been granted by the Sichuan Traditional Chinese Medicine Regional Ethics Review Committee (No. 2019KL-050).
慢性阻塞性肺疾病(COPD)是一种常见的高负担且严重致残的肺部疾病。由于呼吸肌和骨骼肌萎缩,COPD患者的生活质量和运动耐力通常较低。尽管慢性阻塞性肺疾病全球倡议指南推荐了肺康复(PR),但由于其固有的局限性,尚未得到广泛应用。吐纳回春功(TNHCG)是中国一种流行的用于治疗COPD的传统运动。我们旨在评估TNHCG用于COPD肺康复的安全性和有效性。
所提供的方案是一项单盲随机对照试验,120例COPD患者将被随机且等分为试验组或对照组。对照组将接受标准的COPD药物治疗,而试验组除标准药物治疗外还将进行TNHCG锻炼。治疗期为24周,随访48周。主要结局将是6分钟步行试验。次要结局将包括肺功能测试、圣乔治呼吸问卷、COPD评估测试、改良医学研究委员会呼吸困难量表、医院焦虑抑郁量表以及急性加重频率。试验期间还将进行安全性评估。
我们的研究将为支持TNHCG锻炼作为COPD肺康复的一项额外措施提供证据。
ChiCTR1900028332,于2019年12月29日注册。
已获得四川省中医药区域伦理审查委员会的伦理批准(编号2019KL - 050)。