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Clinical Trial 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.


Clinical Trial 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 method like a coin flip to decide if the participants will be doing PDAE or walking. Importantly, the investigators will see if brain cells are protected using a brain scan that looks at the areas affected by PD to determine the relative amounts of different hormones in the brain that are related to having Parkinson's. The investigators will use these measurements of these hormones to chart the course of brain cell breakdown in patients with PD who have done walking or PDAE for 16 months. The investigators think that that PDAE will be better at lessening OFF-time and making cognition better than walking. The investigators think this because participants have to really use the mind during PDAE because the participants have so much to think about in terms of the steps and patterns. The investigators will assign 102 Veterans with mild-moderate PD to either 16 months of PDAE or walking. The investigators will use a coin toss or other similar method to determine who goes in what group. The investigators need participants to be in the classes for 16-months because it takes that long for us to see if anything changed in the brain with those hormones. Participants will do twice weekly classes for the first 3 months and then will switch down to taking lessons just 1 time per week for 13 months. The investigators will schedule appointments for participants to be seen by the research team before Veterans begin lessons, at 3 months (after the twice weekly schedule) and at 16 months after all the lessons are completed. The appointments will consist of asking the Veterans about their OFF-time having them take a few memory and thinking tests. The investigators will also ask them to lie in a scanner for about an hour. The participants can rest in the scanner for about a 1/2 hour and also do a thinking task. The investigators will be able to answer the questions, "Is PDAE better than walking at lessening OFF-time and spatial cognition and slowing down brain cell death? This study is using cutting edge imaging techniques for the first time to see if dance or walking are helpful for slowing brain cell death. This project combines patient-centered, clinical science and mechanistic aims to improve health care. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04122690
Study type Interventional
Source VA Office of Research and Development
Contact Madeleine E Hackney, PhD
Phone (404) 321-6111
Email mehackn@emory.edu
Status Recruiting
Phase N/A
Start date January 25, 2021
Completion date October 31, 2025

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