Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
NCT Number: NCT04140708
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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Notify Me55 year–80 year
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37212, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: baseline to 12 weeks
Using MRI/PET scans to measure change from baseline to followup of beta-amyloid levels
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Vanderbilt University Medical Center
Other
Acronym: FIGHTPD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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