使用弹性阻力运动进行力量训练对帕金森病 H&Y 1-3 期患者运动和非运动症状的影响:一项随机对照试验的研究方案(PARK-BAND 研究)。

Effects of a power strength training using elastic resistance exercises on the motor and non-motor symptoms in patients with Parkinson's disease H&Y 1-3: study protocol for a randomised controlled trial (PARK-BAND Study).

机构信息

Geriatric Division, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil

Medical School, Universidade de Fortaleza, Fortaleza, Brazil.

出版信息

BMJ Open. 2020 Oct 12;10(10):e039941. doi: 10.1136/bmjopen-2020-039941.

Abstract

INTRODUCTION

Parkinson's disease (PD) is the second most common neurodegenerative disorder in Brazil. Physical activity is a complementary intervention in managing inherent declines associated with the disease like strength, balance, gait, and functionality and benefit health-related outcomes. Here, we report the PARK-BAND Study protocol, which aims to investigate potential benefits of power training using elastic devices in participants with PD. Our intervention will be provided in patients with PD using elastic devices like elastic bands and tubes. Therefore, we used the term Park from Parkinson's disease and band from elastic bands.

METHODS AND ANALYSIS

This randomised single-blind single-centre two-arm parallel, superiority trial will include 50 participants with PD attending the clinical setting. Those who meet the eligibility criteria and provide consent to participate will be randomised in a 1:1 ratio to either the exercise group, which will receive power training programme or the health education group, which will receive the education programme. Randomisation will be performed by permuted block randomisation with a block size of eight. Both groups will receive a 12-week intervention. The exercise group will have two sessions per week and the health education group will have one session per week. Changes from baseline in bradykinesia, as assessed by the Unified Parkinson's Disease Rating Scale motor examination subscore and physical functional performance, will be the primary outcomes. Secondary outcomes include other neurological, neurophysiological and physical variables, as well as the quality of life, depression, cognition, sleep quality and disturbances, assessed before and after interventions. We hypothesise that the exercise group will have greater improvement in primary and secondary outcomes than the health education group.

ETHICS AND DISSEMINATION

The study is approved by the Research Ethics Committee of Hospital Universitário Walter Cantidio and all participants will provide their written informed consent (register number 91075318.1.0000.5045).Trial results will be disseminated via peer reviewed journal articles and conference presentations, reports for organisations involved with PD and for participants.

TRIAL REGISTRATION NUMBER

Registro Brasileiro de Ensaios Clínicos Registry (RBR-5w2sqt); Pre-results.

摘要

简介

帕金森病(PD)是巴西第二常见的神经退行性疾病。身体活动是管理与疾病相关的固有下降的补充干预措施,如力量、平衡、步态和功能,并有益于健康相关结果。在这里,我们报告了 PARK-BAND 研究方案,该方案旨在研究使用弹性装置进行力量训练对 PD 患者的潜在益处。我们的干预措施将在 PD 患者中使用弹性装置,如弹性带和管。因此,我们使用了来自帕金森病的 Park 和来自弹性带的 band。

方法和分析

这是一项随机、单盲、单中心、两臂平行、优效性试验,将包括 50 名在临床环境中就诊的 PD 患者。符合入选标准并同意参与的患者将以 1:1 的比例随机分为运动组(接受力量训练方案)或健康教育组(接受教育方案)。随机分组采用区组随机化,区组大小为 8。两组均接受 12 周的干预。运动组每周进行 2 次训练,健康教育组每周进行 1 次训练。主要结局是使用统一帕金森病评定量表运动检查子量表和身体功能表现评估的运动迟缓变化。次要结局包括其他神经学、神经生理学和身体变量以及生活质量、抑郁、认知、睡眠质量和障碍,在干预前后进行评估。我们假设运动组在主要和次要结局方面的改善将大于健康教育组。

伦理和传播

该研究已获得 Hospital Universitário Walter Cantidio 研究伦理委员会的批准,所有参与者将提供书面知情同意书(注册号 91075318.1.0000.5045)。试验结果将通过同行评审的期刊文章和会议报告、与 PD 相关的组织报告以及参与者报告进行传播。

试验注册号

巴西临床试验注册处(RBR-5w2sqt);预注册结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/904c/7552828/e17f9e148766/bmjopen-2020-039941f01.jpg

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