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北欧式健走对哮喘患者的疗效:一项随机对照试验的研究方案。

Effectiveness of nordic walking in patients with asthma: A study protocol of a randomized controlled trial.

机构信息

The Faculty of Physiotherapy, The University of A Coruña, A Coruña, Galicia, Spain.

Center for Health Technology and Services Research (CINTESIS), Faculty of Medicine, University of Porto (FMUP), Porto, Portugal.

出版信息

PLoS One. 2023 Mar 9;18(3):e0281007. doi: 10.1371/journal.pone.0281007. eCollection 2023.

Abstract

BACKGROUND

Patients with asthma often consider their symptomatology a barrier to exercise, leading to a reduced physical activity level. This study aims to determine whether the effect of a Nordic walking (NW) training program plus education and usual care is superior to educational and usual care only, in terms of exercise tolerance and other health-related outcomes in patients with asthma. The second aim is to explore the patients' experience with the NW program.

METHODS

A randomized controlled trial will be conducted with 114 adults with asthma recruited in sanitary area of A Coruña, Spain. Participants will be randomized to NW or control groups in blocks of six and in the same proportion in each group. Participants in the NW group will enrol in supervised sessions during eight weeks, three times/week. All participants will receive three educational sessions on asthma self-management plus usual care (S1 Appendix). Outcomes such as exercise tolerance (primary outcome), physical activity level, asthma-related symptoms and asthma control, dyspnea, lung function, handgrip strength, health related quality of life, quality of sleep, treatment adherence and healthcare resources use will be measured pre and postintervention, and at three and six months of follow-up. Participants in the NW group will additionally participate in focus groups.

DISCUSSION

This is the first study analysing the effect of NW in patients with asthma. NW combined with education and usual care is expected to improve exercise tolerance, but also asthma-related outcomes. If this hypothesis is confirmed, a new community-based therapeutic approach will be available for patients with asthma.

TRIAL REGISTRATION

Study registered in ClinicalTrials.gov with number of register NCT05482620.

摘要

背景

哮喘患者常将其症状视为运动的障碍,导致身体活动水平降低。本研究旨在确定北欧式健走(NW)训练计划加教育和常规护理对哮喘患者的运动耐量和其他健康相关结果的影响是否优于仅接受教育和常规护理。第二个目的是探讨患者对 NW 计划的体验。

方法

将在西班牙拉科鲁尼亚卫生区招募 114 名成年哮喘患者进行随机对照试验。参与者将按块(每组 6 人)和每组相同的比例随机分为 NW 或对照组。NW 组的参与者将在八周内参加三次/周的监督课程。所有参与者将接受三次关于哮喘自我管理的教育课程,外加常规护理(S1 附录)。将在干预前、干预后以及 3 个月和 6 个月的随访中测量如运动耐量(主要结局)、身体活动水平、哮喘相关症状和哮喘控制、呼吸困难、肺功能、握力、健康相关生活质量、睡眠质量、治疗依从性和医疗保健资源使用等结局。NW 组的参与者还将参加焦点小组。

讨论

这是第一项分析 NW 在哮喘患者中的作用的研究。预计 NW 结合教育和常规护理将改善运动耐量,但也将改善哮喘相关结局。如果这一假设得到证实,将为哮喘患者提供一种新的基于社区的治疗方法。

试验注册

在 ClinicalTrials.gov 上注册的研究,注册号为 NCT05482620。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bc95/9997906/14af43fe8a05/pone.0281007.g001.jpg

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