Study In Parkinson Disease Of Exercise Phase 3 Clinical Trial: Sparx3
Posted Date: Sep 14, 2020
- Investigator: Alberto Espay
- Type of Study: Observational/Survey
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 participants 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, cardiorespiratory fitness, blood-derived biomarkers of inflammation and neurotrophic factors at 12 and 18 months. Exploratory objectives will test hypotheses related to the effects of removing the study support that was provided over 18 months on the sustainability and durability of the exercise effects at 24 months.
The Main Inclusion Criteria Include A Diagnosis Of Idiopathic Pd Based On The Modified *Uk Pd Brain Bank Criteria, A Hoehn And Yahr Stage Less Than 3, A Disease Duration: Less Than 3 Years Since Disease Diagnosis, Be In The Age Range Of 40-80 Years Old, And Have A Positive Datscan™ Spect By Qualitative Visual Assessment From The Institute Of Neurodegenerative Disorders. Women Must Have A Negative Pregnancy Test Before The Datscan If Not Sterile Or Postmenopausal. The Main Exclusion Criteria Include Not Being On Any Pd Medications, Presence Of Known Cardiovascular, Metabolic, Or Renal Disease Or Individuals With Major Signs Or Symptoms Suggestive Of Cardiovascular, Metabolic, Or Renal Disease Without Medical Clearance To Participate In The Exercise Program, Uncontrolled Hypertension, Etc.
Parkinson's Disease, Exercise
For More Information:
Jessica Marchbank (Doak)