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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
Hoehn-Yahr Stage I-III, on stable dopaminergic treatment regimen for equal or greater than 4 weeks prior to baseline
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upchange from baseline average performance for right and left finger tapping at 1 year
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Parkinson's Disease
LTAE-PD Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
People aged 40 and older diagnosed with Parkinson's disease according to specific criteria.
Select...
You are at a certain stage of Parkinson's disease and have been on the same medication for at least 4 weeks before starting the study.
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Your aerobic fitness level is below what is considered very good for your age and gender during a cycling test.
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You do not have dementia according to specific criteria from the Movement Disorder Society.
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,583 Previous Clinical Trials
2,897,618 Total Patients Enrolled
University of IowaOTHER
435 Previous Clinical Trials
870,246 Total Patients Enrolled
Ergun Y. Uc, MDPrincipal InvestigatorIowa City VA Health Care System, Iowa City, IA
1 Previous Clinical Trials
104 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You don't have severe memory or thinking problems according to specific guidelines.Your aerobic fitness level is not very good for your age and gender, based on a cycling test.You have a valid driver's license and are currently able to drive.This study is open to both veterans and non-veterans.You have parkinsonism caused by medication or other conditions.You have a condition that includes symptoms similar to Parkinson's disease.You have had brain surgery for Parkinson's disease, like deep brain stimulation.Your vision is not clear enough (worse than 20/50) to drive safely.You have health conditions that make it unsafe for you to participate in exercise, according to the American College of Sports Medicine guidelines.You have a serious head injury or post-traumatic stress disorder (PTSD).You cannot have a brain MRI for medical reasons.People aged 40 and older diagnosed with Parkinson's disease according to specific criteria.You are at a certain stage of Parkinson's disease and have been on the same medication for at least 4 weeks before starting the study.Your aerobic fitness level is below what is considered very good for your age and gender during a cycling test.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).You have taken certain types of medications for mental health within the last 6 months.You have been diagnosed with dementia according to specific criteria.
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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