Clinical trial NCT04140708: Effects of Exercise on Glymphatic Functioning and Neurobehavioral Correlates in Parkinson's Disease
Official title: Effects of Exercise on Glymphatic Functioning and Neurobehavioral Correlates in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease and Parkinsonism
Glymphatic System
Keywords: Exercise
Parkinson's
Glymphatic System
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2019-10-28
Enrollment: 37
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Beta-Amyloid Levels
timeFrame: baseline to 12 weeks
measure: Change in Hopkins Verbal Learning Test (HVLT) Scores
timeFrame: baseline to 12 weeks
measure: Change in Movement Disorder Society--Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS)
timeFrame: baseline to 12 weeks
measure: Mini-Balence Evaluation Systems Test (BESTest)
timeFrame: baseline to 12 weeks
measure: Freezing of Gait Questionnaire (FOG-Q)
timeFrame: baseline to 12 weeks
measure: Trail Making Test A&B (TMT)
timeFrame: baseline to 12 weeks
measure: Letter Fluency (FAS)
timeFrame: baseline to 12 weeks
measure: Simon Task
timeFrame: baseline to 12 weeks
measure: Patient Recorded Outcomes Measurement Information System-Sleep Disturbance (PROMIS-Sleep)
timeFrame: baseline to 12 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline to 12 weeks
measure: Stroop Interference Task
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: ActiGraphy
timeFrame: continuous between baseline and 12 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Associate Professor
name: Daniel Claassen, MD
role: PRINCIPAL_INVESTIGATOR
References: