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不同中医养生功法干预对中老年健康人群肺功能影响的随机对照研究方案

Effect of different conditioning methods of traditional Chinese health exercise on lung function in healthy middle-aged and elderly people: study protocol for a randomized controlled trial.

机构信息

College of Chinese Wushu, Shanghai University of Sport, 200 Hengren Road, Yangpu District, Shanghai, China.

Office of P.E teachers, Shanghai Institute of Tourism, Shanghai, China.

出版信息

Trials. 2022 Jan 3;23(1):8. doi: 10.1186/s13063-021-05980-5.

Abstract

BACKGROUND

Lung function is highly age-dependent as it decreases in varying degrees with age, even in healthy people. Decreased lung function results in less elastic lung tissue, reduced chest wall compliance, reduced area for gas exchange, and even a variety of chronic diseases. Traditional Chinese health exercise (TCHE) has three components: "breath regulation," "body regulation," and "heart regulation," which play an important role in the improvement of lung function. However, which component has the most significant effect on lung functioning remains unclear. Therefore, depending on the modality of conditioning, TCHEs will be divided into three exercise intervention groups: breath regulation group, body regulation group, and heart regulation group, in order to explore the magnitude of the effect of the different modalities of conditioning on the improvement of lung function.

METHODS

The prospective, parallel, single-blind, randomized controlled trial will evaluate the effects of different conditioning methods of TCHE on lung function in middle-aged and elderly people. The study subjects are healthy middle-aged and elderly adults, who will be randomly divided into the "breath regulation group," "body regulation group," "heart regulation group," and "control group." The control group will receive health education. Health education and exercise intervention in the three intervention groups will be provided for 6 months, 5 times a week, with each session lasting 60 min. The outcomes of interest include changes in the pulmonary function tests measured at baseline and 3 and 6 months after the beginning of the intervention. The primary outcome is the forced vital capacity (FVC), while the secondary outcomes include forced expiratory volume in 1 s (FEV1), FVC/FEV1 ratio, vital capacity (VC), and maximal voluntary ventilation (MVV).

DISCUSSION

This study will assess the effects of different conditioning methods of TCHE on lung function in middle-aged and elderly people. The final findings of this study will validate the effectiveness and safety of TCHE on lung function interventions in middle-aged and elderly people.

TRIAL REGISTRATION

China Clinical Trial Registry ChiCTR2100052687 . Registered on November 3, 2021.

摘要

背景

肺功能随年龄的增长而高度依赖,即使在健康人群中也会以不同程度下降。肺功能下降导致肺组织弹性降低、胸壁顺应性降低、气体交换面积减少,甚至引发多种慢性疾病。传统中医养生功法(TCME)由“调身”“调心”“调息”三部分组成,对改善肺功能有重要作用。但哪种成分对肺功能的影响最大尚不清楚。因此,根据调身方式的不同,TCME 将分为呼吸调节组、身体调节组和心脏调节组三个运动干预组,以探讨不同调身方式对改善肺功能的影响程度。

方法

本前瞻性、平行、单盲、随机对照试验将评估不同 TCME 调身方式对中老年人群肺功能的影响。研究对象为健康的中老年成年人,将随机分为“呼吸调节组”“身体调节组”“心脏调节组”和“对照组”。对照组接受健康教育。三组干预组接受健康教育和运动干预,每周 5 次,每次 60 分钟,共 6 个月。观察指标包括干预前、干预 3 个月和 6 个月后肺功能检查的变化。主要结局指标为用力肺活量(FVC),次要结局指标包括 1 秒用力呼气容积(FEV1)、FVC/FEV1 比值、肺活量(VC)和最大自主通气量(MVV)。

讨论

本研究将评估不同 TCME 调身方式对中老年人群肺功能的影响。本研究的最终发现将验证 TCME 对中老年人群肺功能干预的有效性和安全性。

试验注册

中国临床试验注册中心 ChiCTR2100052687 。于 2021 年 11 月 3 日注册。

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