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

NCT05204680 | Completed DMC

• 1 other identifier: 22-500-203-70-04
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in MDS-NMS score

  Following 3-month exercise regimen

• Change in number of symptoms reported

  Following 3-month exercise regimen

• Change in LFP

  Following 3-month exercise regimen

Study Arms (1)

Aerobic Exercise

EXPERIMENTAL

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

Interventions

Aerobic Exercise BEHAVIORAL

The participant will work with the physical therapist on an exercise regimen.

Aerobic Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead

Study Sites (1)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sana Aslam, DO

  Barrow Neurological Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 24, 2022
• Study Start: June 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)