Effects of Exercise on Glymphatic Functioning and Neurobehavioral Correlates in Parkinson's Disease

NCT ID: NCT04140708

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-22
• Study Completion Date: 2023-09-05

Brief Summary

This study is designed to measure the change in patients diagnosed with Parkinson's disease (PD) before, during and after a 12 week exercise program.The focus of this study is the glymphatic system. The glymphatic system is a recentlydiscovered novel waste clearance pathway, in patients with Parkinson's Disease (PD).The glymphatic system acts as a waste-clearance system in the brain of vertebrate animals.The glymphatic system has been proposed in which new clearance pathways involving communication between paravascular spaces, interstitial fluid, and ultimately meningeal and dural lymphatic vessels exists, and we have provided evidence that this system may be dysfunctional in patients with Parkinson's disease with cognitive disorders. Early research suggest glymphatic function increases following exercise, this response is believed to clear beta-amyloid in the brain and may mediate the neurobehavioral response to exercise in PD.

This study will use cognitive exams, neurological exams as well as specialized imaging to record data points and evaluate the glymphatic function after exercise.

Conditions

Parkinson's Disease and Parkinsonism; Glymphatic System

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise--Rock Steady Boxing class

Participants will be going twice a week to a Rock Steady Boxing class for an hour/class. Participants will be going to this class for a total of three months.

Group Type: EXPERIMENTAL

Exercise--Rock Steady Boxing class

Intervention Type: BEHAVIORAL

Rock Steady Boxing is a class designed specifically for those with Parkinsonism and movement difficulty using explosive and fine tuned movements as well as cognitive learning skills.

Interventions

Exercise--Rock Steady Boxing class

Rock Steady Boxing is a class designed specifically for those with Parkinsonism and movement difficulty using explosive and fine tuned movements as well as cognitive learning skills.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Participant has Parkinson's disease as defined by the UK Brain Bank Criteria.

• Patient has demonstrated a positive levodopa or related therapy response.
• Participant is willing and able to participate in a Rock Steady Boxing class.
• Participation reports a typically sedentary lifestyle in the 6 months prior to enrollment, i.e., no daily-to-weekly, guided, aerobic or non-aerobic exercise routine.
• Participant agreeable to an overnight dopaminergic medication washout period.
• Subject has an identified, reliable method of attending study appointments and Rock Steady Boxing classes.

Exclusion Criteria

• Clinical Dementia Rating scale score <=1
• Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI) or medical conditions that may interfere with their ability to enter the scanner and/or interfere with interpretation of acquired MRI scanning data (e.g., a pacemaker or any other implanted device or condition that would preclude proximity to a strong magnetic field).
• Any contraindication to overnight dopaminergic medication washout period.
• Any contraindication to participation in Rock Steady Boxing.
• Subject resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period.
• Signs or symptoms of untreated obstructive sleep apnea (i.e., 3+ of the 8 STOP-Bang OSA items). Treatment-compliant OSA patients will not be excluded.
• Signs of MSA, probable Alzheimer disease (according to National Institute of Neurological and Communicative Disorders and Stroke, and the Alzheimer's Disease and Related Disorders), probable vascular dementia (history of cognitive decline concurrent with evidence of cerebrovascular disease progression on neuroimaging).
• Evidence of any clinically significant neurological disorder including but not limited to motor neuron disease or Amyotrophic Lateral Sclerosis (ALS), normal pressure hydrocephalus, brain tumor, seizure disorder, multiple sclerosis, or known structural brain abnormalities.
• History of severe or repeated head injury.
• History of encephalitis.
• Subject has had a significant illness or infection requiring medical intervention in the past 30 days.
• History of neuroleptic use (with the exception of pimivanserin, clozapine or quetiapine) for a prolonged period of time or within the past 6 months.
• Any clinically significant hematological, autoimmune, endocrine, cardiovascular, neoplastic, renal, gastrointestinal, or other disorder that, in the Investigator's opinion, could interfere with the subject's participation in the study, place the subject at increased risk, or confound interpretation of study results.
• Current enrollment in another interventional clinical study involving a therapeutic agent.
• Consideration by the investigator, for any reason, that the subject is an unsuitable candidate.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Daniel Claassen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Claassen, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

GRANT12719996

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

191206

Identifier Type: -

Identifier Source: org_study_id