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Dance Aerobics for Parkinson's Disease (PDAE in PD Trial)

N/A
Recruiting
Led By Madeleine E. Hackney, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fluent in English to comprehend and participate
Able to walk with or without an assistive device at least 10 feet
Must not have
Alcohol abuse and/or use of antipsychotics
History of stroke, or traumatic brain injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will show if PDAE protects brain cells in people with PD.

Who is the study for?
This trial is for people over 40 with Parkinson's Disease who can walk at least 10 feet, have mild cognitive impairment or better, and experience 'OFF-time' when their medication isn't effective. They must see benefits from Parkinson's medications and speak English well. Excluded are those with major depression, brain injuries, severe hearing loss, past PDAE/WAE class attendance, alcohol abuse, plans to move away soon, MRI contraindications like claustrophobia or metal implants.
What is being tested?
The study tests whether Partnered Dance Aerobic Exercise (PDAE) can protect the brain and improve movement and thinking in Parkinson’s patients compared to Walking Aerobic Exercise (WAE). It looks at how these exercises affect 'OFF-time', cognition by using a special brain scan called an MRI to measure changes in brain activity related to exercise.
What are the potential side effects?
While specific side effects aren't listed for this type of physical therapy intervention, general risks may include muscle soreness or strain from exercise. The MRI procedure might be uncomfortable for some due to the confined space.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fluent in English and can understand and participate fully.
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I can walk at least 10 feet, with or without help like a cane.
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I am over 40 years old.
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My Parkinson's symptoms improve with medication.
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My Parkinson's disease is in the early to mid-stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not abuse alcohol or use antipsychotics.
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I have had a stroke or traumatic brain injury in the past.
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I have not been treated for major depression or any serious mental illness.
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I do not have major health issues like kidney failure or heavy alcohol use that would stop me from joining an exercise program.
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I do not have severe heart problems like heart failure, aortic stenosis, or uncontrolled chest pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Corsi Blocks product score
Movement disorders Society Unified Parkinson's Disease Rating Scale Part IV total score
rate of change in iron accumulation in the substantia nigra pars compacta
Secondary study objectives
6 minute walk test (number of meters walked in 6 minutes)
Benton's judgment of line orientation task
Executive function: Tower Of London achievement score
+6 more
Other study objectives
Beck depression inventory score
Dynamic Gait index
Four Square Step Test (time to complete)
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Partnered Dance Aerobic ExerciseExperimental Treatment1 Intervention
Partnered Dance-Aerobic Exercise (PDAE) is an adapted form of Argentine tango, aka Adapted tango. Participants with PD will dance the follower role only and will dance with new partners (individuals without PD) every 15-20 minutes, a widely practiced method considered by the dance teaching community to enhance learning. Participants will engage in partnering exercises on how to interpret motor goals through touch, exercises to develop understanding of temporal relationship of movement to music, novel step introduction, connecting previously learned and novel step elements. Frequent repetition and musical stereotypes may foster implicit learning or muscle memory (i.e., motor learning, or procedural memory that involves consolidating a specific motor task into memory through repetition). Participants will not be required to memorize specific step patterns but will learn new steps in each class
Group II: Walking Aerobic ExerciseActive Control1 Intervention
Walking Aerobic Exercise (WAE) Participants in WAE will receive equivalent dose, volume, frequency, intensity and duration of exercise to the PDAE group. The investigators will receive equal contact and monitoring from study staff. WAE participants will report to the same facility and interact with the same interventionist and assistants. The investigators will participate in sessions focused on at least 60 minutes of walking with breaks ad libitum, and 1/2 hour balance and stretching. The investigators have a designated, safe and non-cluttered area for walking. WAE will also take place in groups, with research volunteers and assistants to ensure that PDAE and WAE participants both receive a socially engaging intervention.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,654 Total Patients Enrolled
Madeleine E. Hackney, PhDPrincipal InvestigatorAtlanta VA Medical and Rehab Center, Decatur, GA
2 Previous Clinical Trials
210 Total Patients Enrolled

Media Library

Partnered Dance Aerobic Exercise Clinical Trial Eligibility Overview. Trial Name: NCT04122690 — N/A
Parkinson's Disease Research Study Groups: Partnered Dance Aerobic Exercise, Walking Aerobic Exercise
Parkinson's Disease Clinical Trial 2023: Partnered Dance Aerobic Exercise Highlights & Side Effects. Trial Name: NCT04122690 — N/A
Partnered Dance Aerobic Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04122690 — N/A
~3 spots leftby Dec 2024