Back to resultsEffects of Exercise on Glymphatic Functioning and Neurobehavioral Correlates in Parkinson's Disease (FIGHTPD)
Primary Purpose
Parkinson's Disease and Parkinsonism, Glymphatic System
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise--Rock Steady Boxing class
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease and Parkinsonism focused on measuring Exercise, Parkinson's, Glymphatic System
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.
Sites / Locations
- Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise--Rock Steady Boxing class
Arm 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.
Outcomes
Primary Outcome Measures
Change in Beta-Amyloid Levels
Using MRI/PET scans to measure change from baseline to followup of beta-amyloid levels
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04140708
First Posted
October 24, 2019
Last Updated
September 6, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT04140708
Brief Title
Effects of Exercise on Glymphatic Functioning and Neurobehavioral Correlates in Parkinson's Disease
Acronym
FIGHTPD
Official Title
Effects of Exercise on Glymphatic Functioning and Neurobehavioral Correlates in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2019 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease and Parkinsonism, Glymphatic System
Keywords
Exercise, Parkinson's, Glymphatic System
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise--Rock Steady Boxing class
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise--Rock Steady Boxing class
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Beta-Amyloid Levels
Description
Using MRI/PET scans to measure change from baseline to followup of beta-amyloid levels
Time Frame
baseline to 12 weeks
Title
Change in Hopkins Verbal Learning Test (HVLT) Scores
Description
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.
Time Frame
baseline to 12 weeks
Title
Change in Movement Disorder Society--Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS)
Description
UPDRS measures ease of movement. Highest Score is 108, lowest score is 0. The higher the score, the more difficult movement is for patient.
Time Frame
baseline to 12 weeks
Title
Mini-Balence Evaluation Systems Test (BESTest)
Description
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.
Time Frame
baseline to 12 weeks
Title
Freezing of Gait Questionnaire (FOG-Q)
Description
Measures walking gait and how stable it is. Highest score is 24, lowest is 0. The higher the score, the worse walking gait is.
Time Frame
baseline to 12 weeks
Title
6 Minute Walk Test
Description
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.
Time Frame
baseline to 12 weeks
Title
Trail Making Test A&B (TMT)
Description
TMT measures executive functioning and error detection. Measured with time to complete trails. Higher time to complete means more difficulty with executive functioning.
Time Frame
baseline to 12 weeks
Title
Letter Fluency (FAS)
Description
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.
Time Frame
baseline to 12 weeks
Title
Simon Task
Description
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.
Time Frame
baseline to 12 weeks
Title
Brief Estimate of Seconds (BEST)
Description
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.
Time Frame
baseline to 12 weeks
Title
Patient Recorded Outcomes Measurement Information System-Sleep disturbance (PROMIS-Sleep)
Description
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.
Time Frame
baseline to 12 weeks
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
baseline to 12 weeks
Title
Clinical Dementia Rating (CDR)
Description
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.
Time Frame
baseline to 12 weeks
Title
Stroop interference task
Description
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.
Time Frame
baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Neurametrix
Description
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.
Time Frame
continuous between baseline and 12 weeks
Title
ActiGraphy
Description
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.
Time Frame
continuous between baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Claassen, MD
Phone
6153226103
Email
daniel.claassen@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kaitlyn Hay, MS
Email
kaitlyn.r.hay@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Claassen, MD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Effects of Exercise on Glymphatic Functioning and Neurobehavioral Correlates in Parkinson's Disease
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