Clinical trial NCT05204680: Exercise in Advanced Parkinson's Disease (PD) With Deep Brain Stimulation (DBS)
Official title: Exercise in Advanced Parkinson's Disease (PD) With Deep Brain Stimulation (DBS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

* Individuals with Parkinson's Disease
* Age \>18
* 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

Primary outcomes:
measure: Proportion of study participants who complete at least 80% of the exercise sessions during the 3-month follow-up period
timeFrame: Following 3-month exercise regimen
Secondary outcomes:
measure: Change in MDS-NMS score
timeFrame: Following 3-month exercise regimen
measure: Change in number of symptoms reported
timeFrame: Following 3-month exercise regimen
measure: Change in LFP
timeFrame: Following 3-month exercise regimen
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
Study officials:
affiliation: Barrow Neurological Institute
name: Sana Aslam, DO
role: PRINCIPAL_INVESTIGATOR
References: