Trial Outcomes & Findings for Effects of Exercise on Glymphatic Functioning and Neurobehavioral Correlates in Parkinson's Disease (NCT NCT04140708)

NCT ID: NCT04140708

Last Updated: 2025-03-19

Results Overview

Using MRI/PET scans to measure change from baseline to followup of beta-amyloid levels

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: baseline to 12 weeks
• Results posted on: 2025-03-19

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	37
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Exercise--Rock Steady Boxing Class n=37 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants
Age, Continuous	68.22 years STANDARD_DEVIATION 6.59 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 12 weeks

Using MRI/PET scans to measure change from baseline to followup of beta-amyloid levels

Outcome measures

Measure

Exercise--Rock Steady Boxing Class n=26 Participants 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.

Change in Beta-Amyloid Levels

0.016675963 SUVr Standard Deviation 0.037511718

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Exercise--Rock Steady Boxing Class n=26 Participants 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.
Change in Hopkins Verbal Learning Test (HVLT) Scores HVLT	1.67 score on a scale Standard Deviation 3.83
Change in Hopkins Verbal Learning Test (HVLT) Scores HVLT Delayed Recall	0.78 score on a scale Standard Deviation 1.78

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Exercise--Rock Steady Boxing Class n=26 Participants 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.

Change in Movement Disorder Society--Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS)

2.79 score on a scale Standard Deviation 14.10

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Exercise--Rock Steady Boxing Class n=26 Participants 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.

Mini-Balence Evaluation Systems Test (BESTest)

4.00 score on a scale Standard Deviation 3.64

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Exercise--Rock Steady Boxing Class n=19 Participants 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.

Freezing of Gait Questionnaire (FOG-Q)

0.1052631578947 Units on a scale Standard Deviation 0.6578362547106

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Exercise--Rock Steady Boxing Class n=26 Participants 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.
Trail Making Test A&B (TMT) TMT A	3.94 score on a scale Standard Deviation 24.99
Trail Making Test A&B (TMT) TMT B	2.82 score on a scale Standard Deviation 50.78

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Exercise--Rock Steady Boxing Class n=26 Participants 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.

Letter Fluency (FAS)

1.57 score on a scale Standard Deviation 6.86

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Exercise--Rock Steady Boxing Class n=18 Participants 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.

Simon Task

1.2777777777777 seconds Standard Deviation 5.3556518310984

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Exercise--Rock Steady Boxing Class n=26 Participants 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.
Patient Recorded Outcomes Measurement Information System-Sleep Disturbance (PROMIS-Sleep) PROMIS-SRI	-0.21 score on a scale Standard Deviation 5.47
Patient Recorded Outcomes Measurement Information System-Sleep Disturbance (PROMIS-Sleep) PRMIS-SD	-1.18 score on a scale Standard Deviation 5.62

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Exercise--Rock Steady Boxing Class n=26 Participants 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.
Hospital Anxiety and Depression Scale (HADS) HADS-A	-0.07 score on a scale Standard Deviation 2.58
Hospital Anxiety and Depression Scale (HADS) HADS-D	-0.64 score on a scale Standard Deviation 2.44

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Exercise--Rock Steady Boxing Class n=26 Participants 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.
Stroop Interference Task Stroop-Color	2.83 score on a scale Standard Deviation 5.91
Stroop Interference Task Stroop-Word	3.68 score on a scale Standard Deviation 13.71
Stroop Interference Task Stroop-Color/Word	3.38 score on a scale Standard Deviation 5.75

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Exercise--Rock Steady Boxing Class n=28 Participants 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.

ActiGraphy

8314.22 average step count Standard Deviation 2904.98

Adverse Events

Exercise--Rock Steady Boxing Class

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Exercise--Rock Steady Boxing Class n=37 participants at risk 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.

Investigations tracer synthesis issue

5.4% 2/37 • Number of events 2 • 12 weeks per patient participation

Additional Information

Dr. Daniel Claassen

Vanderbilt University Medical Center

Phone: 615-322-6103

Email: daniel.claassen@vumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place