Status:
ACTIVE_NOT_RECRUITING
Partnered Dance Aerobic Exercise as a Neuroprotective, Motor and Cognitive Intervention in Parkinson's Disease
Lead Sponsor:
VA Office of Research and Development
Conditions:
Parkinson's Disease
Exercise Therapy
Eligibility:
All Genders
40-89 years
Phase:
NA
Brief 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" ...
Detailed Description
The investigators will conduct a study in Veterans and non-Veterans with diagnosed PD to compare PDAE versus walking for OFF-time, cognition, and brain cell protection. The investigators will use a me...
Eligibility Criteria
Inclusion
- Age: older than 40 years (40 is upper limit for young onset PD)
- Montreal Cognitive Assessment (MoCA) score \>17
- Able to walk with or without an assistive device at least 10 feet
- Best corrected/aided acuity better than 20/70 in the better eye
- Willingness to be randomized to either group
- H\&Y stages I-III
- Report OFF times (reporting \>0 on item 4.3 of the UPDRS-IV)
- Show clear symptomatic benefit from antiparkinsonian medications
- e.g., alleviated rigidity, bradykinesia, and tremor
- Fluent in English to comprehend and participate
Exclusion
- Untreated Major Depression and major psychiatric illness
- History of stroke, or traumatic brain injury
- Pure-tone threshold average sensitivity at 0.5, 1.0, and 2.0 kHz exceeds 40 dB
- Previous participation in PDAE or WAE classes.
- Alcohol abuse and/or use of antipsychotics
- Lives outside of the study site or is planning to move out of the area in next year or leave the area for \>1 month during the next year
- Taking moderate to high doses of beta-blockers with a resting heart rate below 60 beats/min since exercise intensity is measured through target heart rate.
- Severe cardiac disease, including:
- New York Heart Association (NYHA) Class III or IV congestive heart failure
- clinically significant aortic stenosis
- history of cardiac arrest, use of a cardiac defibrillator
- uncontrolled angina
- as discussed we are not planning to perform routine exercise tolerance tests prior to enrollment
- Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention
- e.g. renal failure on hemodialysis, excessive alcohol use (\>14 drinks per wk)
- Any contraindications to MRI eg claustrophobia, etc
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2025
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04122690
Start Date
January 25 2021
End Date
October 31 2025
Last Update
July 8 2025
Active Locations (1)
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1
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033-4004