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

Not Applicable

Completed

Conditions: Parkinson's Disease and Parkinsonism
Glymphatic System

Interventions: Behavioral: Exercise--Rock Steady Boxing class

Registration Number: NCT04140708

Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 37

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise--Rock Steady Boxing class	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.

Primary Outcome Measures

Name	Time	Method
Change in Beta-Amyloid Levels	baseline to 12 weeks	Using MRI/PET scans to measure change from baseline to followup of beta-amyloid levels
Change in Hopkins Verbal Learning Test (HVLT) Scores	baseline to 12 weeks	HVLT measures verbal learning skills and memory, highest score is 36 and lowest score is 0. The higher score demonstrates better recall/recognition abilities with verbal learning.
Change in Movement Disorder Society--Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS)	baseline to 12 weeks	UPDRS measures ease of movement. Highest Score is 108, lowest score is 0. The higher the score, the more difficult movement is for patient.
Mini-Balence Evaluation Systems Test (BESTest)	baseline to 12 weeks	Mini-BESTest describes movement ability and balance in different scenarios. Highest score is 28, lowest score is 0. The higher the score, the better balance/movement in different conditions.
Freezing of Gait Questionnaire (FOG-Q)	baseline to 12 weeks	Measures walking gait and how stable it is. Highest score is 24, lowest is 0. The higher the score, the worse walking gait is.
Trail Making Test A&B (TMT)	baseline to 12 weeks	TMT measures executive functioning and error detection. Measured with time to complete trails. Higher time to complete means more difficulty with executive functioning.
Letter Fluency (FAS)	baseline to 12 weeks	FAS measures how many words a patient can list in a minute beginning with a certain letter (F, A, or S), relating to verbal learning and executive function. The lowest score is 0 words, and the more words listed in a minute beginning with each letter, the better executive functioning. FAS is a unitary neuropsychometric test composed of sub-tasks (F, A, S). The individual scores should not be / are not interpreted.
Simon Task	baseline to 12 weeks	The Simon task is another well-validated measure of inhibitory action control which has also been studied extensively in PD. This is a conflict task which measures the effect of interfering impulses on the ability to select a goal response. Scores are measured in % accuracy from 0-100, and reaction times from 0 ms and upward per item. The higher the accuracy and lower the reaction time, the better the inhibitory action control and executive functioning. The outcome we used is mean and standard deviation of reaction time (seconds) for items correctly responded to.
Patient Recorded Outcomes Measurement Information System-Sleep Disturbance (PROMIS-Sleep)	baseline to 12 weeks	The PROMIS measures sleep disturbance and impairment. The lowest score is an 8 and the highest is a 40. The higher the score, the worse sleep impairment or disturbance is.
Hospital Anxiety and Depression Scale (HADS)	baseline to 12 weeks	The HADS measures anxious and depressive feelings in patients. There are 2 parts, Anxiety, where the lowest score would be a 0 and the highest is 21, and the higher a score is, the more anxious behaviors there are. The second part is a depressive behavior scale, which the lowest score is 0, and the highest is 21, and the higher the score, the more depressive behaviors there are.
Stroop Interference Task	baseline to 12 weeks	The stroop interference task measures Measures completion time and number of errors, both corrected and not corrected, and total errors. The low and high scores are patient dependent upon performance, and the higher the scores, the more errors have been made and the worse executive functioning. The amount of time taken on the Stroop task also correlates to having worse executive functioning with a higher completion time.

Secondary Outcome Measures

Name	Time	Method
ActiGraphy	continuous between baseline and 12 weeks	Measures movement patterns during daily activities and exercise. This is measured in steps taken and movement sensors. The higher amount of steps and activity, the more that they are being active and doing exercise.