STEPWISE 研究：基于智能手机的帕金森病患者运动解决方案的研究方案（随机对照试验）。
The STEPWISE study: study protocol for a smartphone-based exercise solution for people with Parkinson's Disease (randomized controlled trial).
机构信息
DisordersDonders Institute for Brain, Cognition and Behaviour, Department of Neurology, Center of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center, Nijmegen, the Netherlands.
Harvard Medical School, Boston, MA, USA.
出版信息
BMC Neurol. 2023 Sep 12;23(1):323. doi: 10.1186/s12883-023-03355-8.
BACKGROUND
Exercise has various health benefits for people with Parkinson's disease (PD). However, implementing exercise into daily life and long-term adherence remain challenging. To increase a sustainable engagement with physical activity of people with PD, interventions that are motivating, accessible, and scalable are needed. We primarily aim to investigate whether a smartphone app (STEPWISE app) can increase physical activity (i.e., step count) in people with PD over one year. Our second aim is to investigate the potential effects of the intervention on physical fitness, and motor- and non-motor function. Our third aim is to explore whether there is a dose-response relationship between volume of physical activity and our secondary endpoints.
METHODS
STEPWISE is a double-blind, randomized controlled trial. We aim to include 452 Dutch people with PD who can walk independently (Hoehn & Yahr stages 1-3) and who do not take more than 7,000 steps per day prior to inclusion. Physical activity levels are measured as step counts on the participant's own smartphone and scaled as percentage of each participant's baseline. Participants are randomly assigned to an active control group with an increase of 5-20% (active controls) or any of the three intervention arms with increases of 25-100% (intermediate dose), 50-200% (large dose), or 100-400% (very large dose). The primary endpoint is change in step count as measured by the STEPWISE smartphone app from baseline to 52 weeks. For our primary aim, we will evaluate the between-group difference in average daily step count change from baseline to 52 weeks. For our second aim, measures of physical fitness, and motor- and non-motor function are included. For our third aim, we will associate 52-week changes in step count with 52-week changes in secondary outcomes.
DISCUSSION
This trial evaluates the potential of a smartphone-based intervention to increase activity levels in people with PD. We envision that motivational apps will increase adherence to physical activity recommendations and could permit conduct of remote clinical trials of exercise for people with PD or those at risk of PD.
TRIAL REGISTRATION
ClinicalTrials.gov; NCT04848077; 19/04/2021.
CLINICALTRIALS
gov/ct2/show/NCT04848077.
背景
运动对帕金森病（PD）患者有多种健康益处。然而，将运动融入日常生活并长期坚持仍然具有挑战性。为了增加 PD 患者对体育活动的可持续参与度，需要采取具有激励性、可及性和可扩展性的干预措施。我们的主要目的是研究智能手机应用程序（STEPWISE 应用程序）是否可以在一年的时间内增加 PD 患者的身体活动量（即步数）。我们的第二个目标是研究该干预措施对身体适应性、运动和非运动功能的潜在影响。我们的第三个目标是探索身体活动量与我们次要终点之间是否存在剂量反应关系。
方法
STEPWISE 是一项双盲、随机对照试验。我们计划纳入 452 名荷兰 PD 患者，这些患者可以独立行走（Hoehn & Yahr 分期 1-3 期），并且在纳入前每天的步数不超过 7000 步。身体活动水平通过参与者自己的智能手机上的步数进行测量，并以每个参与者基线的百分比进行缩放。参与者被随机分配到一个主动对照组，增加 5-20%（主动对照组）或三个干预组中的任何一组，增加 25-100%（中剂量组）、50-200%（大剂量组）或 100-400%（超大剂量组）。主要终点是 STEPWISE 智能手机应用程序从基线到 52 周时的步数变化。对于我们的主要目标，我们将评估从基线到 52 周时平均每日步数变化的组间差异。对于我们的第二个目标，包括身体适应性和运动及非运动功能的测量。对于我们的第三个目标，我们将把 52 周时的步数变化与次要结果的 52 周变化联系起来。
讨论
这项试验评估了基于智能手机的干预措施增加 PD 患者活动水平的潜力。我们设想，激励性应用程序将增加对身体活动建议的依从性，并可能允许对 PD 患者或有患 PD 风险的患者进行远程临床试验。
试验注册
ClinicalTrials.gov；NCT04848077；2021 年 4 月 19 日。
临床试验
gov/ct2/show/NCT04848077。
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