The STEPWISE study: study protocol for a smartphone-based exercise solution for people with Parkinson's Disease (randomized controlled trial).
The STEPWISE study: study protocol for a smartphone-based exercise solution for people with Parkinson's Disease (randomized controlled trial).
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DOI：
10.1186/s12883-023-03355-8
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发表时间：
2023-09-12
期刊：
影响因子：
2.6
通讯作者：
Bloem, Bastiaan R.
中科院分区：
文献类型：
--
作者：
Schootemeijer, Sabine;de Vries, Nienke M.;Macklin, Eric A.;Roes, Kit C. B.;Joosten, Hilde;Omberg, Larsson;Ascherio, Alberto;Schwarzschild, Michael A.;Bloem, Bastiaan R.
锻炼对帕金森氏症（PD）患者有多种健康益处。然而，将锻炼融入日常生活并长期坚持下去仍然具有挑战性。为了增加PD患者对身体活动的可持续参与，需要具有激励性、可获得性和可扩展性的干预措施。我们的主要目的是调查智能手机应用程序（STEPWISE应用程序）是否可以在一年内增加PD患者的身体活动（即步数）。我们的第二个目标是调查干预对身体健康、运动和非运动功能的潜在影响。我们的第三个目的是探索身体活动量和次要终点之间是否存在剂量-反应关系。STEPWISE是一项双盲、随机对照试验。我们的目标是纳入452名荷兰PD患者，他们可以独立行走（Hoehn & Yahr阶段1-3），并且在纳入之前每天不超过7000步。身体活动水平是通过参与者自己的智能手机上的步数来测量的，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增加5-20%的积极对照组（积极对照组）或增加25-100%（中剂量）、50-200%（大剂量）或100-400%（非常大剂量）的三个干预组中的任何一个。主要终点是STEPWISE智能手机应用程序从基线到52周测量的步数变化。对于我们的主要目的，我们将评估从基线到52周的平均每日步数变化的组间差异。对于我们的第二个目标，测量身体健康，运动和非运动功能包括在内。对于我们的第三个目标，我们将52周步数的变化与52周次要结果的变化联系起来。该试验评估了一种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，激励应用程序将提高人们对体育锻炼建议的依从性，并允许对PD患者或有PD风险的人进行远程临床试验。ClinicalTrials.gov;NCT04848077;19/04/2021。Clinicaltrials.gov / ct2 /显示/ NCT04848077。
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. 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. 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. ClinicalTrials.gov; NCT04848077; 19/04/2021. Clinicaltrials.gov/ct2/show/NCT04848077.
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DOI：
10.1007/s13311-020-00904-8
发表时间：
2020-10
期刊：
Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics
影响因子：
--
作者：
Schootemeijer S;van der Kolk NM;Bloem BR;de Vries NM
通讯作者：
de Vries NM
影响因子：
29
作者：
Schenkman, Margaret;Moore, Charity G.;Corcos, Daniel M.
通讯作者：
Corcos, Daniel M.
影响因子：
2.8
作者：
BOSSCHER, RJ;VANDERAA, H;SMIT, JH
通讯作者：
SMIT, JH
影响因子：
8.6
作者：
Leentjens, Albert F. G.;Dujardin, Kathy;Goetz, Christopher G.
通讯作者：
Goetz, Christopher G.
影响因子：
46.9
作者：
Omberg, Larsson;Chaibub Neto, Elias;Mangravite, Lara M.
通讯作者：
Mangravite, Lara M.