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六字诀对慢性阻塞性肺疾病患者肺康复的影响:一项多中心、非随机、前瞻性研究方案。

Effect of Liuzijue on pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: study protocol for a multicenter, non-randomized, prospective study.

机构信息

Zhejiang Chinese Medical University, Binwen Road 548, Binjiang District, Zhejiang, 310053, Hangzhou, China.

The Second Clinical Medical College, Zhejiang Chinese Medical University, Binwen Road 548, Binjiang District, Zhejiang, 310053, Hangzhou, China.

出版信息

BMC Complement Med Ther. 2022 Nov 17;22(1):296. doi: 10.1186/s12906-022-03789-6.

Abstract

BACKGROUND

Traditional Chinese exercise as a new pulmonary rehabilitation technique has been increasingly used and achieved good results in pulmonary rehabilitation of chronic obstructive pulmonary disease (COPD). The aim of this study is to investigate the protective effects of Liuzijue on exercise tolerance, lung function, and quality of life in patients with COPD.

METHODS

This study is a multicenter, non-randomized, prospective study. Patients will be divided into a control group (CG) and a Liuzijue group (LG) based on their willingness to learn Liuzijue. None of the outcome assessors will know the grouping of patients. Participants in this study will be collected from stable COPD patients who are outpatients or inpatients in 3 centers in China since September 2021. Patients will meet the diagnostic criteria for GOLD stage I-II COPD (FEV% ≥ 0.5 and FEV/FVC < 0.7) and be aged 40 years or older. Patients voluntarily will take part in the clinical study and sign an informed consent form. All participants will follow their existing medication. For LG patients, Liuzijue training has been added. Patients will practice Liuzijue for more than 30 minutes a day, more than 5 days a week, and adhere to the training for 3 months. Outcome indicators are 6-minute walk test (6MWT), lung function (FEV%, FEV/FVC, MMEF, PEF), modified British Medical Research Council (mMRC) score, COPD assessment test score (CAT), acute exacerbations and changes in drug treatment.

DISCUSSION

This study quantified the effect of Liuzijue on the pulmonary rehabilitation of COPD patients in the stable phase of the disease, and provided a basis for the use of Liuzijue in COPD patients.

TRIAL REGISTRATION

Chinese clinical trial registry, ChiCTR2100048945. Date: 2021-07-19. http://www.chictr.org.cn/showproj.aspx?proj=129094.

摘要

背景

传统中医功法作为一种新的肺康复技术,已在慢性阻塞性肺疾病(COPD)的肺康复中得到越来越多的应用,并取得了良好的效果。本研究旨在探讨六字诀对 COPD 患者运动耐力、肺功能和生活质量的保护作用。

方法

本研究为多中心、非随机、前瞻性研究。根据患者学习六字诀的意愿,将患者分为对照组(CG)和六字诀组(LG)。所有结果评估者均不知道患者的分组情况。本研究将从中国 3 个中心的稳定期 COPD 门诊或住院患者中收集参与者。患者将符合 GOLD 分期 I-II COPD 的诊断标准(FEV%≥0.5 和 FEV/FVC<0.7),年龄在 40 岁或以上。患者自愿参加临床研究并签署知情同意书。所有参与者将继续使用现有的药物治疗。对于 LG 患者,已增加了六字诀训练。患者每天需练习六字诀超过 30 分钟,每周超过 5 天,并坚持训练 3 个月。观察指标包括 6 分钟步行试验(6MWT)、肺功能(FEV%、FEV/FVC、MMEF、PEF)、改良英国医学研究理事会呼吸困难量表评分(mMRC)、COPD 评估测试评分(CAT)、急性加重和药物治疗的变化。

讨论

本研究量化了六字诀对 COPD 稳定期患者肺康复的影响,为六字诀在 COPD 患者中的应用提供了依据。

试验注册

中国临床试验注册中心,ChiCTR2100048945。日期:2021-07-19。http://www.chictr.org.cn/showproj.aspx?proj=129094。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9f0/9670448/30b91047faf8/12906_2022_3789_Fig1_HTML.jpg

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