Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3
Northwestern University
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.
Description
This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the MDS-UPDRS Part III score at 12 months. 370 persons diagnosed with Parkinson's disease who have not yet initiated dopaminergic therapy, age 40-80, will be randomly assigned to 2 groups: 1)60-65% HRmax or 2)80-85% HRmax 4 times per week. Secondary objectives will test hypotheses related to striatal specific binding ratio (SSBR) at 12 months, MDS-UPDRS Part III score, ambulatory mobility (6-minute walk), daily walking activity (steps), cognition, quality of life, cardiorespira…
Eligibility
- Age range
- 40–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * A diagnosis of idiopathic Parkinson Disease based on the modified \* United Kingdom (UK) PD brain bank criteria and which are consistent with recent criteria proposed for clinically established early established Parkinson's disease that no longer exclude individuals with a family history of Parkinson's disease. * Hoehn and Yahr stages less than 3 * Disease duration: less than 3 years since disease diagnosis * Age 40-80 years * Positive DaTscan™ SPECT by quantitative readout for idiopathic Parkinson disease. Exclusion Criteria: * Currently being treated with PD medicati…
Interventions
- BehavioralTreadmill walking
Treadmill walking 4 days per week for 30 minutes in the target heart rate
Locations (25)
- University of Alabama at BirminghamBirmingham, Alabama
- University of California, San FranciscoSan Francisco, California
- University of Colorado, DenverAurora, Colorado
- University of FloridaGainesville, Florida
- Morehouse School of MedicineAtlanta, Georgia
- Emory UniversityAtlanta, Georgia