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NCT04122690 · ClinicalTrials.gov registry record · NA
Partnered Dance Aerobic Exercise as a Neuroprotective, Motor and Cognitive Intervention in Parkinson's Disease
A NA study of Parkinson's Disease and Cognition, sponsored by VA Office of Research and Development.
- Active
- Registry status
- NA
- Development phase
- 82
- Enrollment target
- 1
- Study location
NCT04122690: Active NA study of Parkinson's Disease and Cognition, sponsored by VA Office of Research and Development.
NCT04122690 is a NA study of Parkinson's Disease and Cognition that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 82 participants, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04122690, a NA study of Parkinson's Disease and Cognition, is active but no longer recruiting, sponsored by VA Office of Research and Development.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 82 participants
- Enrollment target
- 1
- Study location
Study Summary
Parkinson's disease (PD) is a difficult to treat condition that impairs mobility and thinking. It is not fully treated by drugs and surgery. Two priority issues for most people with PD are "OFF-time" and Cognitive impairment. Even under best medical management, 74% of people with PD experience "OFF-time," which is when medications are just not working right. OFF-time severely impacts both quality of life and thinking. Cognitive problems are found even in newly diagnosed people with PD and are very difficult to treat. However, the investigators' research has shown that partnered dance-aerobic exercise (PDAE) reduces OFF-time on the official test for OFF-time of the Movement Disorders Society, the Movement Disorders Society Unified Parkinson Disease Rating Scale-IV, (MDS-UPDRS-IV). PDAE improves other symptoms too. Benefits of the therapy have lasted for at least one-month after PDAE sessions stopped. PDAE provides aerobic exercise during an improvisational, cognitively-engaging physical activity. Cognitive engagement is a critical component of PDAE. Previous research showed PDAE improved spatial cognition, the ability to navigate, to mentally picture shapes and paths in the mind and to know the relationships between objects, people and places. Also, the investigators showed with imaging of the brain using a magnet in a scanner that twice weekly PDAE training increases activity in brain regions used in thinking and decision making. The investigators know that exercise benefits mobility and cognitive problems. The investigators even think exercise might protect brain cells in people with PD. But no one has really been able to show with biomarkers that exercise is protective of brain cells in humans.
Primary Outcome
The primary outcome, the MDS-UPDRS-IV score measures medication related motor fluctuations, including dyskinesias, OFF-time, functional impact and complexity of fluctuations, and dystonia. The investigators will administer a monthly OFF-state diary for corroboration of these scores.
Conditions Studied
Interventions
- BEHAVIORAL PDAE
- BEHAVIORAL WAE
Study Locations (1)
Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2021-01-25 |
| Est. Completion | 2026-12-15 |
| Phase | NA |
What the registry record for NCT04122690 still lists
NCT04122690 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (87% lower).
The record links to 3 conditions, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions - of which PDAE is the first listed.
NCT04122690 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT04122690 about?
NCT04122690 is a clinical study titled "Partnered Dance Aerobic Exercise as a Neuroprotective, Motor and Cognitive Intervention in Parkinson's Disease". Parkinson's disease (PD) is a difficult to treat condition that impairs mobility and thinking. It is not fully treated by drugs and surgery. Two priority issues for most people with PD are "OFF-time" and Cognitive impairment. Even under best medical management, 74% of people with PD experience "OFF-...
What is the current status of trial NCT04122690?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 82 participants. The study started on 2021-01-25. Estimated completion is 2026-12-15.
What conditions does trial NCT04122690 study?
This clinical trial studies the following conditions: Parkinson's Disease, Cognition, Exercise Therapy.
What interventions are being tested in trial NCT04122690?
The interventions under investigation include: PDAE (BEHAVIORAL), WAE (BEHAVIORAL).
Who is sponsoring clinical trial NCT04122690?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04122690 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04122690's enrollment target sits among peer trials
82 62nd of 158 higher than 97 of 158 other Parkinson's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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