Background. Recent studies indicate that exercise can induce neuroplastic changes in people with Parkinson’s disease (PwPD). Reports of feasibility outcomes from existing pilot trials however are, of date, insufficient to enable replication by others in larger definitive trials. Objective. To evaluate trial design for a definitive trial by exploring process and scientific feasibility. Methods. The trial design was a parallel-group RCT pilot with a 1 : 1 allocation ratio to either HiBalance or an active control group (HiCommunication). Both groups received one-hour sessions twice weekly, plus home exercises weekly, for 10 weeks. Participants with mild-to-moderate Parkinson’s disease (PD) were recruited via advertisement. Assessment included physical performance, structural and functional MRI, blood sampling, neuropsychological assessment, and speech/voice assessment. Process and scientific feasibility were monitored throughout the study. Process feasibility involved recruitment, participant acceptability of assessments and interventions, assessment procedures (focus on imaging, blood sampling, and dual-task gait analysis), and blinding procedures. Scientific feasibility involved trends in outcome response and safety during group training and home exercises. Data are presented in median, minimum, and maximum values. Changes from pre- to postintervention are reported descriptively. Results. Thirteen participants were included (4 women, mean age 69.7 years), with a recruitment rate of 31%. Attendance rates and follow-up questionnaires indicated that both groups were acceptable to participate. Image quality was acceptable; however, diplopia and/or sleepiness were observed in several participants during MRI. With regard to dual-task gait performance, there appeared to be a ceiling effect of the cognitive tasks with seven participants scoring all correct answers at pretest. Blinding of group allocation was successful for one assessor but was broken for half of participants for the other. Conclusions. The overall trial design proved feasible to perform, but further strengthening ahead of the definitive RCT is recommended, specifically with respect to MRI setup, cognitive dual-tasks during gait, and blinding procedures. This trial is registered with NCT03213873.

中文翻译：

---

探索运动诱发的帕金森病神经可塑性的可行性方面：一项初步随机对照试验。

背景。最近的研究表明，运动可以诱发帕金森病 (PwPD) 患者的神经可塑性变化。然而，迄今为止，现有试点试验的可行性结果报告不足以让其他人在更大的确定性试验中进行复制。客观。通过探索过程和科学可行性来评估最终试验的试验设计。方法. 试验设计是一个平行组 RCT 试点，与 HiBalance 或主动对照组 (HiCommunication) 的分配比例为 1:1。两组每周两次接受一小时的训练，外加每周一次的家庭锻炼，持续 10 周。通过广告招募患有轻度至中度帕金森病 (PD) 的参与者。评估包括身体表现、结构和功能 MRI、血液采样、神经心理学评估和语音/语音评估。在整个研究过程中监测过程和科学可行性。过程可行性涉及招募、评估和干预的参与者可接受性、评估程序（专注于成像、采血和双任务步态分析）和盲法程序。科学可行性涉及小组训练和家庭练习期间结果反应和安全性的趋势。数据以中值、最小值和最大值表示。描述性地报告从干预前到干预后的变化。结果。包括 13 名参与者（4 名女性，平均年龄 69.7 岁），招募率为 31%。出勤率和后续调查问卷表明两组都可以参加。图像质量可以接受；然而，在 MRI 期间，一些参与者观察到复视和/或嗜睡。关于双任务步态表现，认知任务似乎存在天花板效应，七名参与者在预测试中对所有正确答案进行评分。一位评估员的分组分配盲法是成功的，但另一半的参与者被打破了。结论. 整体试验设计被证明是可行的，但建议在最终 RCT 之前进一步加强，特别是在 MRI 设置、步态期间的认知双重任务和盲法程序方面。该试验已在 NCT03213873 注册。