Partnered Dance Aerobic Exercise as a Neuroprotective, Motor and Cognitive Intervention in Parkin… (NCT04122690) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Partnered Dance Aerobic Exercise as a Neuroprotective, Motor and Cognitive Intervention in Parkinson's Disease
United States82 participantsStarted 2021-01-25
Plain-language 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.
Who can participate
Age range
40 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Movement disorders Society Unified Parkinson's Disease Rating Scale Part IV total score
Timeframe: 16 months
2
Corsi Blocks product score
Timeframe: 16 months
3
rate of change in iron accumulation in the substantia nigra pars compacta