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临床试验/NCT05204680
NCT05204680已完成不适用

Exercise in Advanced Parkinson's Disease (PD) With Deep Brain Stimulation (DBS)

St. Joseph's Hospital and Medical Center, Phoenix2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
2
主要终点
Proportion of study participants who complete at least 80% of the exercise sessions during the 3-month follow-up period

研究概览

简要总结

This project is a 3-month prospective study assessing the immediate and long-term changes associated with aerobic exercise in quality-of-life measures, nonmotor scores, brief neuropsychological batteries, and local field potentials (LFPs) in those with Parkinson's Disease (PD) who have undergone deep brain stimulation (DBS) surgery for management of their symptoms. In this study, the investigators will assess the feasibility of an aerobic exercise regimen in those with advanced PD and DBS, characterize the immediate and long-term changes in neuronal activity with exercise in PD, and assess the nonmotor impact of exercise in individuals with advanced PD and DBS.

The investigators will recruit individuals who are not regular exercisers and develop an individualized 3-month exercise plan with the assistance of physical therapists, using heart rate targets for moderate exercise. Outcomes will be measured at baseline and following 3-months of regular exercise. Field potentials will be noted at baseline, during exercise every 2 weeks, and then a final baseline at the end of 3 months in on-medication and on-stimulation states. This will allow for characterization of field potential changes over time both during exercise as efficiency improves as well as impact on baseline neuronal activity in the resting state. This study is novel in that most aerobic exercise studies target early PD subjects and rarely include those who have undergone DBS surgery. The study will specifically focus on the feasibility of developing an aerobic exercise regimen in those with more advanced disease as well as gathering preliminary data on the impact it will have on motor and nonmotor features in this cohort. In addition to the clinical outcomes, investigators are now able to capture neuronal activity with novel FDA-approved DBS technology, allowing us to non-invasively monitor real-time changes in the basal ganglia in those who have undergone DBS surgery. This study will also aim to characterize baseline neuronal activity in this cohort and monitor for changes that occur during exercise as well as determine if there is a change in baseline neuronal activity as exercise tolerance improves and with consistent, regular aerobic exercise.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals with Parkinson's Disease
  • H&Y stage 1-3 in the medication on and stimulation on state
  • History of STN DBS
  • Able to tolerate exercise from a cardiovascular, cognitive, and orthopedic perspective
  • Not on beta-blockers, as we will be using heart rate-based targets
  • Stable medication and stimulation for 60 days prior to baseline visit
  • Access to exercise equipment

排除标准

  • Medical comorbidities that preclude safe exercise per the discretion of the principal investigator
  • Regular exercisers

结局指标

主要结局

Proportion of study participants who complete at least 80% of the exercise sessions during the 3-month follow-up period

时间窗: Following 3-month exercise regimen

For Objective #1, feasibility of the aerobic exercise regimen will be assessed by the adherence proportion, defined as proportion of study participants who complete at least 80% of the exercise sessions during the 3-month follow-up period. Precision of the proportion estimate will be assessed by the 95% Clopper-Pearson confidence interval (CI).

次要结局

  • Change in number of symptoms reported(Following 3-month exercise regimen)
  • Change in LFP(Following 3-month exercise regimen)
  • Change in MDS-NMS score(Following 3-month exercise regimen)

研究者

发起方
St. Joseph's Hospital and Medical Center, Phoenix
申办方类型
Other
责任方
Sponsor

研究点 (2)

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