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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 months
Awards & highlights
PDAE in PD Trial 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.Check my eligibility
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.See study design
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.
PDAE in PD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
PDAE in PD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreOther outcome measures
Beck depression inventory score
Dynamic Gait index
Four Square Step Test (time to complete)
+12 morePDAE in PD 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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,034 Total Patients Enrolled
Madeleine E. Hackney, PhDPrincipal InvestigatorAtlanta VA Medical and Rehab Center, Decatur, GA
2 Previous Clinical Trials
234 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have previously taken part in PDAE or WAE classes.I am fluent in English and can understand and participate fully.I take beta-blockers and my resting heart rate is below 60.I can walk at least 10 feet, with or without help like a cane.I am over 40 years old.Your ability to hear certain tones at specific frequencies is better than 40 decibels.I do not abuse alcohol or use antipsychotics.Your vision with glasses or contacts is better than 20/70 in your better eye.You experience periods of reduced mobility, as indicated by item 4.3 of the UPDRS-IV assessment form.You scored higher than 17 on the Montreal Cognitive Assessment (MoCA).I have had a stroke or traumatic brain injury in the past.I have not been treated for major depression or any serious mental illness.I do not have major health issues like kidney failure or heavy alcohol use that would stop me from joining an exercise program.My Parkinson's symptoms improve with medication.I do not have severe heart problems like heart failure, aortic stenosis, or uncontrolled chest pain.I am willing to be assigned to any treatment group by chance.My Parkinson's disease is in the early to mid-stage.
Research Study Groups:
This trial has the following groups:- Group 1: Partnered Dance Aerobic Exercise
- Group 2: Walking Aerobic Exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still room for additional participants in this clinical experiment?
"Affirmative. Data provided on clinicaltrials.gov shows that this research project, which was launched on 25th January 2021, is currently recruiting patients. A total of 150 participants are required and they must be sourced from a single trial site."
Answered by AI
What criteria must an individual meet to be considered eligible for this research endeavor?
"This clinical trial is recruiting 150 individuals between 40 and 89 years old who are undergoing therapy or exercise. Prospective participants must have a MoCA score of over 17, corrected visual acuity greater than 20/70 in their best eye, be capable of walking at least 10 feet with or without an assistive device, and report OFF times as indicated by item 4.3 on the UPDRS-IV scale. Additionally, they need to agree to randomization into either group before being accepted for enrollment."
Answered by AI
Is the patient pool for this experiment restricted to individuals younger than 40 years old?
"As stipulated by the trial's inclusion criteria, no participants under 40 years old and none over 89 are allowed to be recruited."
Answered by AI
What aims does this experiment seek to accomplish?
"The primary assessment metric for this 16-month study is the Corsi Blocks product score, while secondary outcomes include cardiovascular output (V02 maximum), executive function (Tower Of London achievement score) and a measurement of neuromelanin loss in substantia nigra pars compacta."
Answered by AI
What is the current enrollment capacity for this medical experiment?
"Correct. The listing on clinicaltrials.gov reveals that this research is actively recruiting individuals and has been since its initial posting of January 25th 2021. There are an estimated 150 participants needed from a single location."
Answered by AI
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