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High-Intensity Treadmill Exercise for Parkinson's Disease (SPARX3 Trial)
N/A
Recruiting
Led By Daniel M Corcos, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hoehn and Yahr stages less than 3
Age 40-80 years
Must not have
(For women only) Actively breast-feeding an infant, and/or pregnant, or plan to become pregnant in the next 12 months.
Individuals with orthostatic hypotension and standing systolic BP below 100 will be excluded. Orthostatic hypotension (OH) is a reduction of systolic blood pressure of at least 20 mm Hg or diastolic blood pressure of at least 10 mm Hg within 3 minutes of standing.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether high-intensity endurance treadmill exercise can help slow the progression of Parkinson's disease in people who have not yet started medication for PD. 370 participants will be randomly assigned to 1 of 2 groups and exercise 4 times per week for 12 months. The primary objective is to see if the progression of PD signs is slowed at 12 months in the group exercising at a higher intensity.
Who is the study for?
This trial is for people aged 40-80 with early-stage Parkinson's disease (diagnosed within the last 3 years and not severe), who haven't started medication. They must have a positive DaTscan, be able to exercise, and not have other serious health issues or recent use of certain medications that could interfere with the study.
What is being tested?
The study tests if high-intensity treadmill exercise can slow down Parkinson's symptoms over a year. Participants are randomly placed in two groups: one does moderate-intensity workouts, while the other does high-intensity workouts, both four times per week.
What are the potential side effects?
Since this trial involves physical exercise, potential side effects may include muscle soreness, fatigue, joint pain or risk of falls. However, these will vary based on individual fitness levels and the intensity of workout sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Parkinson's disease is in the early or mid-stage.
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I am between 40 and 80 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently breastfeeding, pregnant, or plan to be pregnant soon.
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My blood pressure does not drop significantly when I stand up.
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My thyroid, liver, or kidney functions are not normal.
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I am allergic to DaTscan™ or its ingredients.
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I haven't been hospitalized or needed serious treatment in the last month.
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My blood pressure is not higher than 150/90 mmHg.
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My MoCA score is below 24, indicating cognitive challenges.
Select...
I haven't used neuroleptics or dopamine blockers in the last 30 days.
Select...
I am currently taking medication for Parkinson's disease.
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I haven't taken specific medications that could affect brain scans in the last 90 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in activity
Change in blood derived marker of inflammation
Change in blood derived marker of neuronal development
+7 moreOther study objectives
Change in stride length
Change in turning velocity
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: High Intensity ExerciseExperimental Treatment1 Intervention
Treadmill exercise 4x per week at 80-85% HRmax.
Group II: Moderate Intensity ExerciseActive Control1 Intervention
Treadmill exercise 4x per week at 60-65% HRmax.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treadmill walking
2008
N/A
~230
Find a Location
Who is running the clinical trial?
The Parkinson Study GroupNETWORK
16 Previous Clinical Trials
32,131 Total Patients Enrolled
University of PittsburghOTHER
1,787 Previous Clinical Trials
16,358,983 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,642 Previous Clinical Trials
957,702 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition was diagnosed less than 3 years ago.My Parkinson's disease is in the early or mid-stage.I am currently breastfeeding, pregnant, or plan to be pregnant soon.I have heart, metabolism, or kidney issues without clearance for exercise.My dose of mental health medication has been stable for the last 28 days.My blood pressure does not drop significantly when I stand up.My thyroid, liver, or kidney functions are not normal.I am between 40 and 80 years old.Your blood test results are abnormal and your doctor thinks it's important for your health.I do not have any health issues that would stop me from doing endurance exercises.I have been diagnosed with Parkinson's Disease based on UK criteria.I am allergic to DaTscan™ or its ingredients.You have been diagnosed with idiopathic Parkinson's disease based on a specific type of brain scan.I haven't been hospitalized or needed serious treatment in the last month.My blood pressure is not higher than 150/90 mmHg.My MoCA score is below 24, indicating cognitive challenges.Criterion: If you have a score higher than 28 on the Beck Depression Inventory II, it means you have severe depression that makes it hard to participate in the study. If your score is between 17 and 28 and you are suicidal, need changes in your depression treatment, or your depressive symptoms might affect your ability to follow the study rules, you will not be able to join the study. If you fall into this category, you will be referred to a doctor for more evaluation and help with managing your depression.People who have been consistently doing very intense exercise for more than 120 minutes per week in the past 6 months will not be allowed to participate. This is because their exercise level is much higher than what is expected in the study, and they might lose fitness if they change their exercise routine.I haven't taken any Parkinson's disease medication in the last 60 days.I haven't used neuroleptics or dopamine blockers in the last 30 days.I will likely need Parkinson's disease medication within 6 months.I am currently taking medication for Parkinson's disease.You have been taking certain medications for Parkinson's disease for more than 60 days.I haven't taken specific medications that could affect brain scans in the last 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: Moderate Intensity Exercise
- Group 2: High Intensity 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.
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT04284436 — N/A
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