RecruitingNot ApplicableNCT04284436

Study in Parkinson Disease of Exercise

Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3

Sponsor

Northwestern University

Enrollment

370 participants

Start Date

Aug 30, 2021

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

Summary

This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III score at 12 months among persons with early stage Parkinson disease. 370 participants will be randomly assigned to 2 groups: 1)60-65% HRmax or 2)80-85% HRmax 4 times per week. The primary objective is to test whether the progression of the signs of Parkinson's disease is attenuated at 12 months in among persons who have not initiated medication for Parkinson Disease (PD) when they perform high-intensity endurance treadmill exercise.

Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial studies the effects of structured exercise on the early stages of Parkinson's disease. Researchers want to find out whether regular physical activity can slow down the progression of Parkinson's symptoms, and which type of exercise is most beneficial. **You may be eligible if...** - You have been diagnosed with idiopathic Parkinson's disease (Parkinson's not caused by medication or another condition) - Your disease was diagnosed within the past 3 years - Your symptoms are relatively mild (Hoehn and Yahr stage less than 3) - You are between 40 and 80 years old - You have had a DaTscan (a brain imaging test) confirming the diagnosis **You may NOT be eligible if...** - Your Parkinson's is more advanced - You were diagnosed more than 3 years ago - You have other conditions preventing you from exercising safely Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALTreadmill walking

Treadmill walking 4 days per week for 30 minutes in the target heart rate

Locations(25)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California, San Francisco

San Francisco, California, United States

University of Colorado, Denver

Aurora, Colorado, United States

University of Florida

Gainesville, Florida, United States

Morehouse School of Medicine

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Iowa State University

Ames, Iowa, United States

Louisiana State University

Baton Rouge, Louisiana, United States

Boston University (Charles River Campus)

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University St. Louis

St Louis, Missouri, United States

Columbia University Medical Center

New York, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio Health

Columbus, Ohio, United States

Kent State University

Kent, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

UT Health San Antonio

San Antonio, Texas, United States

University of Utah

Salt Lake City, Utah, United States

University of Alberta

Edmonton, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04284436

Related Trials

tDCS on Parkinson's Disease Cognition

NCT030253341 location

Brain Training to Improve Balance in Parkinson's Disease

NCT059866431 location

The University of Alabama at Birmingham (UAB) Neuroinflammation in Parkinson's Disease-TSPO- Positron Emission Tomography (PET) Substudy

NCT034574931 location

World Data on Ambroxol for Patients With GD and GBA Related PD

NCT043889693 locations

Study of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Brain-first and Body-first PD

NCT071878431 location