Relatively short duration studies have demonstrated that high-intensity aerobic exercise improves aspects of motor and nonmotor function in people with Parkinson disease (PwPD); however, the effectiveness of a long-term exercise intervention on slowing disease progression is unknown. The primary aim of this study is to determine the disease-altering effects of high-intensity aerobic exercise, administered on an upright stationary cycle, on the progression of PD. A secondary aim is to develop a prognostic model for 12-month changes of Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS III) scores of people undergoing the aerobic exercise intervention.
This pragmatic, multisite, single-rater blinded randomized controlled trial will be conducted in 2 large, urban, academic medical centers. The exercise intervention will be administered remotely in the homes of 250 participants with mild to moderate idiopathic PD who will be followed for 12 months. Participants will be randomized to (1) home-based aerobic exercise (AE) or (2) usual and customary care (UCC). People in the AE arm will be asked to complete in-home aerobic exercise sessions at 60% to 80% of heart rate reserve 3 times per week for 12 months utilizing a commercially available upright exercise cycle. The UCC group will continue normal activity levels. Daily activity will be monitored for both groups throughout the 12-month study period. The primary outcome, both to assess disease-modifying response to aerobic exercise and for prognostic modeling in the aerobic exercise arm, is 12-month rate of change in MDS-UPDRS III. Clinical and biomechanical measures will also be used to assess upper and lower extremity motor function, and non-motor functions.
If long-term aerobic exercise demonstrates disease-modifying capabilities, this study will provide evidence that “Exercise is Medicine” for PwPD. If so, the derived prognostic model will inform a more patient-specific exercise prescription for PwPD and inform expected disease progression.
© The Author(s) 2021. Published by Oxford University Press on behalf of the American Physical Therapy Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.
About The Expert
Jay L Alberts
Anson B Rosenfeldt
Cielita Lopez-Lennon
Erin Suttman
A Elizabeth Jansen
Peter B Imrey
Leland E Dibble
References
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