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

Parkinson's Disease and Parkinsonism Clinical Trial

— FIGHTPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04140708
• Other study ID #: 191206
• Secondary ID: GRANT12719996
• Status: Completed
• Phase: N/A
• Start date: November 22, 2019
• Est. completion date: September 5, 2023

Study information

• Verified date: January 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 5, 2023
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glymphatic System
• Parkinson Disease
• Parkinson's Disease and Parkinsonism
• Parkinsonian Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Beta-Amyloid Levels	Using MRI/PET scans to measure change from baseline to followup of beta-amyloid levels	baseline to 12 weeks
Primary	Change in Hopkins Verbal Learning Test (HVLT) Scores	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.	baseline to 12 weeks
Primary	Change in Movement Disorder Society--Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS)	UPDRS measures ease of movement. Highest Score is 108, lowest score is 0. The higher the score, the more difficult movement is for patient.	baseline to 12 weeks
Primary	Mini-Balence Evaluation Systems Test (BESTest)	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.	baseline to 12 weeks
Primary	Freezing of Gait Questionnaire (FOG-Q)	Measures walking gait and how stable it is. Highest score is 24, lowest is 0. The higher the score, the worse walking gait is.	baseline to 12 weeks
Primary	6 Minute Walk Test	Measures how well patient can walk in 6 minutes. Score is distance/laps walked in 6 minutes. The higher distance means their walking is better.	baseline to 12 weeks
Primary	Trail Making Test A&B (TMT)	TMT measures executive functioning and error detection. Measured with time to complete trails. Higher time to complete means more difficulty with executive functioning.	baseline to 12 weeks
Primary	Letter Fluency (FAS)	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.	baseline to 12 weeks
Primary	Simon Task	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. The higher the accuracy and lower the reaction time, the better the inhibitory action control and executive functioning.	baseline to 12 weeks
Primary	Brief Estimate of Seconds (BEST)	The BEST measures chrognosis and how well a patient can measure time. It is measured by comparing a difference of estimated time by the patient and mean estimated time by a control group (precalculated), dividing by the standard deviation of that control group, and using the z-score associated with that calculation to determine if the patient observes time sped up or slowed down. A lower/more negative z-score indicates that the patient observes time as going faster, while a higher/more positive z-score indicates that the patient observes time as going slower.	baseline to 12 weeks
Primary	Patient Recorded Outcomes Measurement Information System-Sleep disturbance (PROMIS-Sleep)	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.	baseline to 12 weeks
Primary	Hospital Anxiety and Depression Scale (HADS)	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.	baseline to 12 weeks
Primary	Clinical Dementia Rating (CDR)	The CDR is a clinical interview that measures memory, orientation, judgement, and lifestyle behaviors of the patient. The answers on the interview questions are decided by the clinician to correlate to a scale of 0 to 3, with 0 being the lowest score and high cognition and consciousness, with 3 being the highest score associated with severe mental decline.	baseline to 12 weeks
Primary	Stroop interference task	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.	baseline to 12 weeks
Secondary	Neurametrix	Neurametrix measures typing cadences such as the time spent on one key and the time spent in between key on the keyboard that correspond to cognitive and motor functions. The cadences are using averages for the time spent on one key or between keys, with a higher mean there is less control in movement and less cognitive functioning.	continuous between baseline and 12 weeks
Secondary	ActiGraphy	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.	continuous between baseline and 12 weeks