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High-Intensity Treadmill Exercise for Parkinson's Disease (SPARX3 Trial)
SPARX3 Trial 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.
SPARX3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSPARX3 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SPARX3 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Moderate Intensity Exercise
- Group 2: High Intensity Exercise
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there any age restrictions for participation in the experiment?
"This medical trial is only open to those between the age of 40 and 80. Meanwhile, other clinical studies exist for individuals below 18 years old (27 trials) or over 65 (485 trials)."
Are there any remaining vacancies available for this medical experiment?
"As stated on clinicaltrials.gov, this research venture is currently in need of volunteers. This project was initially posted on August 30th 2021 and the latest update occurred October 25th 2022."
Who is eligible to partake in the experiment?
"This trial is looking for 370 qualified Parkinson's disease sufferers between the ages of 40 and 80. Criteria for entry include a diagnosis confirmed by modified UK PD brain bank standards, Hoehn & Yahr stage less than three, disease duration inside 3 years of initial diagnosis, DaTscan™ SPECT positive quantitative readout indicative of idiopathic Parkinson disease."
What is the current cohort size of this clinical experiment?
"This clinical trial necessitates the participation of 370 individuals who are eligible to participate according to pre-defined criteria. Potential candidates can take part in this research from institutions such as Columbia University Medical Center and the University of Pennsylvania."
How extensively is this trial being coordinated across multiple sites?
"This trial is presently enrolling from a total of 29 sites, which include New york, Philadelphia and Chicago as well as other locations. It would be wise to opt for the closest available centre to ease any travel difficulties associated with enrollment."
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