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| ID | Type | Description | Link |
|---|---|---|---|
| GRANT12719996 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise--Rock Steady Boxing class | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise--Rock Steady Boxing class | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Beta-Amyloid Levels | Using MRI/PET scans to measure change from baseline to followup of beta-amyloid levels | baseline to 12 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Participant has Parkinson's disease as defined by the UK Brain Bank Criteria.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Claassen, MD | Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Beta-Amyloid Levels | Using MRI/PET scans to measure change from baseline to followup of beta-amyloid levels | Posted | Mean | Standard Deviation | SUVr | baseline to 12 weeks |
|
|
12 weeks per patient participation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tracer synthesis issue | Investigations | Non-systematic Assessment | tracer not being synthesized and tested correctly |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Claassen | Vanderbilt University Medical Center | 615-322-6103 | daniel.claassen@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 4, 2024 | Sep 19, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 4, 2024 | Sep 19, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 12, 2021 | Dec 15, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020734 | Parkinsonian Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. FAS is a unitary neuropsychometric test composed of sub-tasks (F, A, S). The individual scores should not be / are not interpreted. |
| baseline to 12 weeks |
| 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 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. | baseline to 12 weeks |
| 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 |
| 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 |
| 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 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | Units on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. FAS is a unitary neuropsychometric test composed of sub-tasks (F, A, S). The individual scores should not be / are not interpreted. | Posted | Mean | Standard Deviation | score on a scale | 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 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. | Posted | Mean | Standard Deviation | seconds | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline to 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. | Posted | Mean | Standard Deviation | average step count | continuous between baseline and 12 weeks |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 2 |
| 37 |
|
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| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |
| Title | Measurements |
|---|---|
|