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Aerobic Exercise for Parkinson's Disease (LTAE-PD Trial)
Phase 2 & 3
Waitlist Available
Led By Ergun Y. Uc, MD
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
Men or women aged 40 and older with the diagnosis of idiopathic PD per UK Brain Bank criteria
Current active drivers with a valid driver's license
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline average performance for right and left finger tapping at 1 year
Awards & highlights
LTAE-PD Trial Summary
This trial will test the long term effects of aerobic exercise on the brain tissue, movement, mental functions, and driving in Parkinson's Disease patients.
Who is the study for?
This trial is for men and women over 40 with Parkinson's Disease (PD) who are still driving, have no dementia, and are on stable PD medication. They should be veterans or non-veterans with a fitness level below 'very good' for their age/gender. Excluded are those unable to consent, with other forms of parkinsonism, brain surgery for PD, poor vision affecting driving, unstable medical conditions, significant depression or recent use of certain drugs.Check my eligibility
What is being tested?
The study tests the long-term effects of aerobic walking compared to usual care combined with PD-specific health education. It aims to see if regular aerobic exercise can improve brain health, movement control, mental functions and maintain driving ability in people living with Parkinson's disease.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects from participating in an aerobic exercise program may include muscle soreness or strain and fatigue. Usual care likely has minimal side effects but could include boredom or lack of motivation.
LTAE-PD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 or older and have been diagnosed with Parkinson's disease.
Select...
I have a valid driver's license and am currently driving.
Select...
My aerobic fitness level is not considered 'very good' for my age and gender.
LTAE-PD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline vo2max on cycle ergometry at 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline vo2max on cycle ergometry at 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MDS-UPDRS Non-motor Experiences of Daily Living subscale (Part I) score
OFF period MDS-UPDRS Motor Subscale score
Percent Increase Score (PIS) on Eriksen's flanker task
+3 moreSecondary outcome measures
Beck Anxiety Inventory (BAI) score
COGSTAT score
Dexterity (time on 9-hole peg board) test of NIH Toolbox motor battery
+16 moreOther outcome measures
VO2max on cycle ergometry
LTAE-PD Trial Design
2Treatment groups
Experimental Treatment
Group I: ControlExperimental Treatment1 Intervention
Participants randomized to usual care with PD specific health education
Group II: AerobicExperimental Treatment1 Intervention
Participants randomized to aerobic exercise
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,546 Total Patients Enrolled
University of IowaOTHER
446 Previous Clinical Trials
879,445 Total Patients Enrolled
Ergun Y. Uc, MDPrincipal InvestigatorIowa City VA Health Care System, Iowa City, IA
1 Previous Clinical Trials
104 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe or unstable health conditions.My Parkinson's is at an early to mid-stage, and I've been on stable Parkinson's medication for over 4 weeks.You don't have severe memory or thinking problems according to specific guidelines.I haven't taken antipsychotic or dopamine blocking drugs in the last 6 months.My Parkinson's symptoms are caused by medication.I have had brain surgery for Parkinson's disease.I am 40 or older and have been diagnosed with Parkinson's disease.You have health conditions that make it unsafe for you to participate in exercise, according to the American College of Sports Medicine guidelines.Your vision is not clear enough (worse than 20/50) to drive safely.I have been diagnosed with a Parkinson-plus syndrome.You have been diagnosed with dementia according to specific criteria.I have a valid driver's license and am currently driving.My aerobic fitness level is not considered 'very good' for my age and gender.You cannot have a brain MRI for medical reasons.You do not have dementia according to specific criteria from the Movement Disorder Society.You have severe depression based on a test score called the Beck Depression Inventory (BDI).I have been on a stable dose of my brain-related medication for at least 30 days.My aerobic fitness level is not considered 'very good' for my age and gender.You have a serious head injury or post-traumatic stress disorder (PTSD).
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Aerobic
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.
Are people with the required medical history still able to sign up for this research program?
"Correct, this research is ongoing and is recruiting participants, as stated on the clinicaltrials.gov website. The listing for this trial was first posted on 7/1/2019, and the most recent update was on 8/26/2022."
Answered by AI
Why was this research project undertaken?
"The aim of this study, as evaluated by the change in Baseline Percent Increase Score (PIS) on Eriksen's flanker task over the course of a year, is to improve regional DTI. Additionally, this study will also monitor changes in motor function, ability to complete activities of daily living, and cognitive and memory skills."
Answered by AI
Who else is applying?
What state do they live in?
Utah
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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