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 range40 Years – 89 Years

SexALL

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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…

What they're measuring

Movement disorders Society Unified Parkinson's Disease Rating Scale Part IV total score

Timeframe: 16 months

Corsi Blocks product score

Timeframe: 16 months

rate of change in iron accumulation in the substantia nigra pars compacta

Timeframe: 16 months

Trial details

NCT IDNCT04122690

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2026-12-15

View on ClinicalTrials.gov More Parkinson's Disease trials

Plain-language summary

Who can participate

Age range40 Years – 89 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.