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Clinical Trials/NCT05204680
NCT05204680CompletedNot Applicable

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

St. Joseph's Hospital and Medical Center, Phoenix2 sites in 1 country11 target enrollmentStarted: June 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
11
Locations
2
Primary Endpoint
Proportion of study participants who complete at least 80% of the exercise sessions during the 3-month follow-up period

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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).

Secondary Outcomes

  • 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)

Investigators

Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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