Effects of Exercise on Glymphatic Functioning and Neurobehavioral Correlates in Parkinson's Disease
NCT04140708, Not applicable, Completed, Vanderbilt University Medical Center; results first posted 2025-03-19
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of Exercise on Glymphatic Functioning and Neurobehavioral Correlates in Parkinson's Disease | ClinicalTrials.gov |
| NCT number | NCT04140708 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 37 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Vanderbilt University Medical Center | ClinicalTrials.gov |
| Conditions | Parkinson's Disease and Parkinsonism, Glymphatic System | ClinicalTrials.gov |
| Interventions | Exercise--Rock Steady Boxing class | ClinicalTrials.gov |
| First posted | 2019-10-28 | ClinicalTrials.gov |
| Last updated | 2025-03-19 | ClinicalTrials.gov |
| Results first posted | 2025-03-19 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Beta-Amyloid Levels | baseline to 12 weeks | Using MRI/PET scans to measure change from baseline to followup of beta-amyloid levels | ClinicalTrials.gov |
| Primary | Change in Hopkins Verbal Learning Test (HVLT) Scores | 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. | ClinicalTrials.gov |
| Primary | Change in Movement Disorder Society--Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS) | 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. | ClinicalTrials.gov |
| Primary | Mini-Balence Evaluation Systems Test (BESTest) | 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. | ClinicalTrials.gov |
| Primary | Freezing of Gait Questionnaire (FOG-Q) | 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. | ClinicalTrials.gov |
| Primary | Trail Making Test A&B (TMT) | 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. | ClinicalTrials.gov |
| Primary | Letter Fluency (FAS) | 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. | ClinicalTrials.gov |
| Primary | Simon Task | 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. | ClinicalTrials.gov |
| Primary | Patient Recorded Outcomes Measurement Information System-Sleep Disturbance (PROMIS-Sleep) | 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. | ClinicalTrials.gov |
| Primary | Hospital Anxiety and Depression Scale (HADS) | 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. | ClinicalTrials.gov |
| Primary | Stroop Interference Task | 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. | ClinicalTrials.gov |
| Secondary | ActiGraphy | 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. | ClinicalTrials.gov |
Outcomes 12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change in Beta-Amyloid Levels | baseline to 12 weeks | SUVr | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in Hopkins Verbal Learning Test (HVLT) Scores | baseline to 12 weeks | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in Movement Disorder Society--Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS) | baseline to 12 weeks | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Mini-Balence Evaluation Systems Test (BESTest) | baseline to 12 weeks | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Freezing of Gait Questionnaire (FOG-Q) | baseline to 12 weeks | Units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Trail Making Test A&B (TMT) | baseline to 12 weeks | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Letter Fluency (FAS) | baseline to 12 weeks | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Simon Task | baseline to 12 weeks | seconds | MEAN | ClinicalTrials.gov | |
| PRIMARY | Patient Recorded Outcomes Measurement Information System-Sleep Disturbance (PROMIS-Sleep) | baseline to 12 weeks | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Hospital Anxiety and Depression Scale (HADS) | baseline to 12 weeks | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Stroop Interference Task | baseline to 12 weeks | score on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | ActiGraphy | continuous between baseline and 12 weeks | average step count | MEAN | ClinicalTrials.gov |
Results by group 18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change in Beta-Amyloid Levels | Exercise--Rock Steady Boxing Class | 0.016675963 | Standard Deviation 0.037511718 | SUVr | ClinicalTrials.gov | |
| Change in Hopkins Verbal Learning Test (HVLT) Scores | Exercise--Rock Steady Boxing Class | HVLT | 1.67 | Standard Deviation 3.83 | score on a scale | ClinicalTrials.gov |
| Change in Hopkins Verbal Learning Test (HVLT) Scores | Exercise--Rock Steady Boxing Class | HVLT Delayed Recall | 0.78 | Standard Deviation 1.78 | score on a scale | ClinicalTrials.gov |
| Change in Movement Disorder Society--Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS) | Exercise--Rock Steady Boxing Class | 2.79 | Standard Deviation 14.10 | score on a scale | ClinicalTrials.gov | |
| Mini-Balence Evaluation Systems Test (BESTest) | Exercise--Rock Steady Boxing Class | 4.00 | Standard Deviation 3.64 | score on a scale | ClinicalTrials.gov | |
| Freezing of Gait Questionnaire (FOG-Q) | Exercise--Rock Steady Boxing Class | 0.1052631578947 | Standard Deviation 0.6578362547106 | Units on a scale | ClinicalTrials.gov | |
| Trail Making Test A&B (TMT) | Exercise--Rock Steady Boxing Class | TMT A | 3.94 | Standard Deviation 24.99 | score on a scale | ClinicalTrials.gov |
| Trail Making Test A&B (TMT) | Exercise--Rock Steady Boxing Class | TMT B | 2.82 | Standard Deviation 50.78 | score on a scale | ClinicalTrials.gov |
| Letter Fluency (FAS) | Exercise--Rock Steady Boxing Class | 1.57 | Standard Deviation 6.86 | score on a scale | ClinicalTrials.gov | |
| Simon Task | Exercise--Rock Steady Boxing Class | 1.2777777777777 | Standard Deviation 5.3556518310984 | seconds | ClinicalTrials.gov | |
| Patient Recorded Outcomes Measurement Information System-Sleep Disturbance (PROMIS-Sleep) | Exercise--Rock Steady Boxing Class | PROMIS-SRI | -0.21 | Standard Deviation 5.47 | score on a scale | ClinicalTrials.gov |
| Patient Recorded Outcomes Measurement Information System-Sleep Disturbance (PROMIS-Sleep) | Exercise--Rock Steady Boxing Class | PRMIS-SD | -1.18 | Standard Deviation 5.62 | score on a scale | ClinicalTrials.gov |
| Hospital Anxiety and Depression Scale (HADS) | Exercise--Rock Steady Boxing Class | HADS-A | -0.07 | Standard Deviation 2.58 | score on a scale | ClinicalTrials.gov |
| Hospital Anxiety and Depression Scale (HADS) | Exercise--Rock Steady Boxing Class | HADS-D | -0.64 | Standard Deviation 2.44 | score on a scale | ClinicalTrials.gov |
| Stroop Interference Task | Exercise--Rock Steady Boxing Class | Stroop-Color | 2.83 | Standard Deviation 5.91 | score on a scale | ClinicalTrials.gov |
| Stroop Interference Task | Exercise--Rock Steady Boxing Class | Stroop-Word | 3.68 | Standard Deviation 13.71 | score on a scale | ClinicalTrials.gov |
| Stroop Interference Task | Exercise--Rock Steady Boxing Class | Stroop-Color/Word | 3.38 | Standard Deviation 5.75 | score on a scale | ClinicalTrials.gov |
| ActiGraphy | Exercise--Rock Steady Boxing Class | 8314.22 | Standard Deviation 2904.98 | average step count | ClinicalTrials.gov |
Participant flow 3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Exercise--Rock Steady Boxing Class | 37 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Exercise--Rock Steady Boxing Class | 28 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Exercise--Rock Steady Boxing Class | 9 | ClinicalTrials.gov |
Adverse events 1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | tracer synthesis issue | Investigations | Exercise--Rock Steady Boxing Class | 2 | 37 | 2 | ClinicalTrials.gov |
Adverse event totals 3
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Exercise--Rock Steady Boxing Class | 0 | 37 | ClinicalTrials.gov |
| Total, other adverse events | Exercise--Rock Steady Boxing Class | 2 | 37 | ClinicalTrials.gov |
| Total, serious adverse events | Exercise--Rock Steady Boxing Class | 0 | 37 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Simon Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)