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

Vanderbilt University Medical Center logo

Vanderbilt University Medical Center

Status

Completed

Conditions

Glymphatic System
Parkinson's Disease and Parkinsonism

Treatments

Behavioral: Exercise--Rock Steady Boxing class

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT04140708
191206
GRANT12719996 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

55 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

28 participants in 1 patient group

Exercise--Rock Steady Boxing class
Experimental group
Description:
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.
Treatment:
Behavioral: Exercise--Rock Steady Boxing class

Trial documents
1

Trial contacts and locations

0

Loading...

Central trial contact

Daniel Claassen, MD; Kaitlyn Hay, MS

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems