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

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 Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Aerobic Exercise

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Aerobic Exercise; The participant will work with the physical therapist on an exercise regimen and first session will be supervised with the therapist. Exercise protocols will include a 15-minute warmup and cooldown session as well. To allow for increased participation and accessibility, the means of aerobic exercise will not be restricted and any safe mechanism of exercise will be allowed e.g., treadmill, stationary bike, etc. Subjects will be provided an activity monitor (Phillips HealthBand Monitor) for the duration of study participation and receive training on how to use it, including marking events with start and stop of exercise sessions and tracking heart rate. The device can track type of activity as well as cardio fitness index and VO2max.

Behavioral: Aerobic Exercise; The participant will work with the physical therapist on an exercise regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of study participants who complete at least 80% of the exercise sessions during the 3-month follow-up period	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).	Following 3-month exercise regimen

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in MDS-NMS score	For Objective #2, the primary outcome, the change in total (Movement Disorder Society - Non-Motor Scale (MDS-NMS) score from baseline to three months. MDS-NMS is reported as a score from 0-334, with higher scores being worse. In secondary analysis we will summarize and compare the score of each individual domain between the two time points (depression, anxiety, apathy, psychosis, impulse control, cognition, orthostatic hypotension, urinary, sexual, gastrointestinal, sleep, pain, and other).	Following 3-month exercise regimen
Change in number of symptoms reported	Proportion of subjects with each non-motor symptom (with score of at least 1). The total number of symptoms and number of symptoms within each domain will be compared using the Wilcoxon signed-rank test.	Following 3-month exercise regimen
Change in LFP	For the exploratory objective to study changes in neuronal activity, we will use linear and non-linear mixed effects models to study the trend in the biweekly measurements of local field potentials (LFPs) parameters over time. The LFP parameters, including power, sample entropy, arrhythmicity, and asymmetry primarily in beta bands but will also explore other frequencies, will be transformed, if needed, to achieve approximate normality. Random intercepts based on patient and STN will be included in the model. In addition, changes in LFP parameters from baseline to various time points will be associated with changes in total and domain-specific MDS-NMS scores from baseline to three months using linear regression models.	Following 3-month exercise regimen

Collaborators and Investigators

• Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Investigators: Principal Investigator: Sana Aslam, DO, Barrow Neurological Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 22-500-203-70-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No