Laboratory of Clinical Research in Kinesiology, Department of Kinesiology, Universidad Católica del Maule, Talca, Chile.
São Paulo State University (UNESP), Graduate Program in Movement Sciences, Department of Physical Education, Human Movement Research Laboratory (MOVI-LAB), Bauru, Brazil.
Trials. 2021 Apr 6;22(1):250. doi: 10.1186/s13063-021-05177-w.
Automated peripheral mechanical stimulation (AMPS) has been proposed as a new complementary therapy with potential for improving motor and cardiovascular abnormalities in Parkinson's disease (PD). However, AMPS long-term effects and its combination with physical exercise are unknown. Thus, this study aims to compare the effects of a program of 12 weeks of physical exercise with a 12-week intervention program combining physical exercise and AMPS on the aerobic capacity, cardiac autonomic control, and gait parameters in patients with PD.
A randomized, controlled clinical trial will be conducted. Older volunteers with PD will be randomly assigned to one of the two groups studied: (1) exercise or (2) AMPS + exercise. Both groups will undergo an exercise program of 24 sessions, for 12 weeks, performed twice a week. Before exercise sessions, the group AMPS + exercise will receive a session of active AMPS, while the group exercise will receive an AMPS sham intervention. Shapiro-Wilk's and Levene's tests will be used to check for data normality and homogeneity, respectively. In case parametric assumptions are fulfilled, per-protocol and intention-to-treat analyses will be performed using a mixed model analysis of variance to check for group*time interaction. Significance level will be set at 5%.
Several non-pharmacological treatment modalities have been proposed for PD, focusing primarily on the reduction of motor and musculoskeletal disorders. Regular exercise and motor training have been shown to be effective in improving quality of life. However, treatment options in general remain limited given the high prevalence and adverse impact of these disorders. So, developing new strategies that can potentiate the improvement of motor disabilities and also improve non-motor symptoms in PD is relevant. It is expected that the participants from both groups will improve their quality of life, gait parameters, and their cardiac autonomic control, with greater improvements being observed in the group combining active AMPS and physical exercise.
ClinicalTrials.gov NCT04251728 . Registered on February 05, 2020.
自动化外周机械刺激（AMPS）已被提议作为一种新的补充疗法，具有改善帕金森病（PD）运动和心血管异常的潜力。然而，AMPS 的长期效果及其与体育锻炼的结合尚不清楚。因此，本研究旨在比较 12 周体育锻炼方案与结合体育锻炼和 AMPS 的 12 周干预方案对 PD 患者的有氧能力、心脏自主控制和步态参数的影响。
将进行一项随机对照临床试验。患有 PD 的老年志愿者将被随机分配到以下两个研究组之一：（1）运动组或（2）AMPS+运动组。两组均将接受 24 次、12 周的运动方案，每周两次。在运动前，AMPS+运动组将接受一次主动 AMPS 治疗，而运动组将接受一次 AMPS 假干预。Shapiro-Wilk 检验和 Levene 检验将分别用于检查数据的正态性和同质性。如果满足参数假设，则使用混合模型方差分析进行方案内和意向治疗分析，以检查组间时间交互作用。显著性水平设为 5%。
已经提出了几种非药物治疗方法来治疗 PD，主要侧重于减少运动和肌肉骨骼障碍。有研究表明，定期锻炼和运动训练可有效提高生活质量。然而，鉴于这些疾病的高患病率和不良影响，治疗选择仍然有限。因此，开发新的策略可以增强运动障碍的改善，同时改善 PD 的非运动症状是相关的。预计两组参与者的生活质量、步态参数和心脏自主控制都会得到改善，在结合主动 AMPS 和体育锻炼的组中，改善效果更为明显。
ClinicalTrials.gov NCT04251728。注册于 2020 年 2 月 5 日。
