STEPS 试验设计：一项评价基于电子健康的运动认知家庭训练治疗帕金森病的 II 期随机对照试验。

Design of the STEPS trial: a phase II randomized controlled trial evaluating eHealth-supported motor-cognitive home training for Parkinson's disease.

机构信息

Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden.

Stockholm Sjukhem Foundation, Research and development unit, Stockholm, Sweden.

出版信息

BMC Neurol. 2023 Oct 4;23(1):356. doi: 10.1186/s12883-023-03389-y.

DOI:10.1186/s12883-023-03389-y

PMID:37794320

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10548709/

Abstract

BACKGROUND

Electronic health (eHealth) technology offers the potential to support and motivate physical activity for symptom management in Parkinson's disease (PD). It is also recommended that motor exercise in PD be complemented with cognitive training aimed at attentional or executive functions. This paper describes the protocol for a double-blind randomized controlled trial to evaluate the effects of motor-cognitive training in the home environment, supported by eHealth.

METHODS/DESIGN: The Support for home Training using Ehealth in Parkinsons diseaSe (STEPS) is a double-blind single center randomized controlled trial. Two parallel groups will include in total 120 participants with mild to moderate PD who will receive either (i) the intervention (a progressive 10-week individualized motor-cognitive eHealth training with cognitive behavioral elements to increase physical activity levels) or (ii) an active control group (an individualized 10-week paper-based home exercise program). The active control group will not receive motor-cognitive exercises or cognitive behavioral approaches to increase physical activity level. The primary outcome is walking capacity assessed by the six-minute walk test (6MWT). Secondary outcomes will include gait performance during single and dual task conditions, gait speed, functional mobility and lower limb strength, balance, physical activity behavior and a range of patient reported outcome measures relevant in PD.

DISCUSSION

The STEPS trial will answer the question whether 10 weeks of eHealth supported motor-cognitive exercise in the home environment can improve walking capacity in PD when compared to a standard paper exercise program. Findings from this study will also strengthen the evidence concerning the efficacy of PD-specific eHealth interventions with a view meeting future health care demands by addressing issues of inaccessibility to specialized neurological rehabilitation in PD.

TRIAL REGISTRATION

ClinicalTrials.gov August 2022, NCT05510739.

摘要

背景

电子健康（eHealth）技术具有支持和激励帕金森病（PD）患者进行身体活动以进行症状管理的潜力。也建议在 PD 中进行运动锻炼的同时进行认知训练，以改善注意力或执行功能。本文描述了一项双盲随机对照试验的方案，以评估在 eHealth 支持下的家庭环境中的运动认知训练的效果。

方法/设计：支持帕金森病居家训练的电子健康方案（STEPS）是一项双盲单中心随机对照试验。两个平行组将共纳入 120 名轻度至中度 PD 患者，他们将接受以下两种干预措施之一：（i）干预组（一项为期 10 周的个体化运动认知 eHealth 训练，包括认知行为元素，以提高身体活动水平）或（ii）主动对照组（一项为期 10 周的个体化纸质家庭运动计划）。主动对照组将不接受运动认知练习或认知行为方法来提高身体活动水平。主要结局是六分钟步行测试（6MWT）评估的步行能力。次要结局将包括单任务和双任务条件下的步态表现、步态速度、功能性移动能力和下肢力量、平衡、身体活动行为以及一系列与 PD 相关的患者报告结局测量。

讨论

STEPS 试验将回答一个问题，即与标准纸质运动计划相比，10 周的 eHealth 支持家庭环境中的运动认知训练是否可以改善 PD 患者的步行能力。该研究的结果还将加强针对 PD 特定的 eHealth 干预措施的疗效证据，以期通过解决 PD 中专门神经康复的不可及性问题来满足未来的医疗保健需求。