Design of the WHIP-PD study: a phase II, twelve-month, dual-site, randomized controlled trial evaluating the effects of a cognitive-behavioral approach for promoting enhanced walking activity using mobile health technology in people with Parkinson-disease
Design of the WHIP-PD study: a phase II, twelve-month, dual-site, randomized controlled trial evaluating the effects of a cognitive-behavioral approach for promoting enhanced walking activity using mobile health technology in people with Parkinson-disease
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DOI：
10.1186/s12883-020-01718-z
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发表时间：
2020-04-20
期刊：
影响因子：
2.6
通讯作者：
Ellis, Terry D.
中科院分区：
文献类型：
--
作者：
Rawson, Kerri S.;Cavanaugh, James T.;Ellis, Terry D.
帕金森病（PD）是一种使人衰弱的慢性神经退行性疾病，导致行动困难。尽管运动障碍相对稳定，但在疾病进展的早期，自然步行活动经常减少。在这项研究中，我们提出了一种范式转变，即使用认知行为训练和移动健康（mHealth）技术，以现实世界的行走为目标，采用“连接行为方法”。步行和移动健康增加帕金森病参与（WHIP-PD）研究是一项为期12个月、双中心、双臂、随机对照试验，招募了148名早期至中期帕金森病患者。参与者将被随机分配到相关的行为或主动控制条件。这两种情况都将包括一个定制的以目标为导向的步行计划，增强步行的强化练习，以及与物理治疗师的八次亲自访问。相关行为条件的参与者还将(1)接受认知行为训练，以提高日常行走行为的自我效能；(2)使用移动健康软件应用程序管理他们的计划，并与他们的物理治疗师远程沟通。主动控制组的参与者将不接受认知行为训练，并在纸上管理他们的计划。评估将在基线、3个月、6个月和12个月进行，包括步行评估、自我效能问卷调查和7天的活动监测。主要结果将包括基线和12个月之间总体步行活动量（每天平均步数）和中等强度步行活动量（每天累积100步的平均分钟数）的变化。次要结果将包括通过6分钟步行测试和10米步行测试测量的步行能力的变化。我们还将检验自我效能是否介导步行活动量的变化以及步行活动量的变化是否介导步行能力的变化。我们期望本研究表明，在增加现实世界步行活动的数量和强度以及提高步行能力方面，连接行为方法比主动控制条件更有效。确定PD患者有效的身体活动干预措施对于保持活动能力和维持生活质量至关重要。临床试验注册号NCT03517371, 2018年5月7日。
Background Parkinson disease (PD) is a debilitating and chronic neurodegenerative disease resulting in ambulation difficulties. Natural walking activity often declines early in disease progression despite the relative stability of motor impairments. In this study, we propose a paradigm shift with a "connected behavioral approach" that targets real-world walking using cognitive-behavioral training and mobile health (mHealth) technology. Methods/design The Walking and mHealth to Increase Participation in Parkinson Disease (WHIP-PD) study is a twelve-month, dual site, two-arm, randomized controlled trial recruiting 148 participants with early to mid-stage PD. Participants will be randomly assigned to connected behavioral or active control conditions. Both conditions will include a customized program of goal-oriented walking, walking-enhancing strengthening exercises, and eight in-person visits with a physical therapist. Participants in the connected behavioral condition also will (1) receive cognitive-behavioral training to promote self-efficacy for routine walking behavior and (2) use a mHealth software application to manage their program and communicate remotely with their physical therapist. Active control participants will receive no cognitive-behavioral training and manage their program on paper. Evaluations will occur at baseline, three-, six-, and twelve-months and include walking assessments, self-efficacy questionnaires, and seven days of activity monitoring. Primary outcomes will include the change between baseline and twelve months in overall amount of walking activity (mean number of steps per day) and amount of moderate intensity walking activity (mean number of minutes per day in which > 100 steps were accumulated). Secondary outcomes will include change in walking capacity as measured by the six-minute walk test and ten-meter walk test. We also will examine if self-efficacy mediates change in amount of walking activity and if change in amount of walking activity mediates change in walking capacity. Discussion We expect this study to show the connected behavioral approach will be more effective than the active control condition in increasing the amount and intensity of real-world walking activity and improving walking capacity. Determining effective physical activity interventions for persons with PD is important for preserving mobility and essential for maintaining quality of life. Clinical trials registration NCT03517371, May 7, 2018.