Jay L Alberts1,2, Anson B Rosenfeldt1, Cielita Lopez-Lennon3, Erin Suttman3, A Elizabeth Jansen1, Peter B Imrey4,5,6, Leland E Dibble3. 1. Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio, USA. 2. Center for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio, USA. 3. Department of Physical Therapy and Athletic Training, University of Utah, Salt Lake City, Utah, USA. 4. Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio, USA. 5. Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, Ohio, USA. 6. Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, USA.
Abstract
OBJECTIVE: Previous short duration studies have demonstrated that high-intensity aerobic exercise improves aspects of motor and non-motor 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 in the Movement Disorder Society Unified Parkinson's Disease Rating Scale III (MDS-UPDRS III) of PwPD undergoing an aerobic exercise intervention. METHODS: This pragmatic, multisite, single-rater blinded, randomized controlled trial will recruit PwPD from 2 large, urban, academic medical centers. Participants (N = 250 PwPD) will be randomized to (1) home-based aerobic exercise or (2) usual and customary care. Those in the aerobic exercise 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 usual and customary care 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 the MDS-UPDRS III. Clinical and biomechanical measures will also be used to assess upper and lower extremity motor function as well as non-motor functions. IMPACT: Should long-term aerobic exercise demonstrate disease-modifying capability, this study will provide evidence that "Exercise is Medicine" for PwPD. Further, the derived prognostic model will inform a patient-specific exercise prescription for PwPD and expected effects on PD progression.
OBJECTIVE: Previous short duration studies have demonstrated that high-intensity aerobic exercise improves aspects of motor and non-motor 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 in the Movement Disorder Society Unified Parkinson's Disease Rating Scale III (MDS-UPDRS III) of PwPD undergoing an aerobic exercise intervention. METHODS: This pragmatic, multisite, single-rater blinded, randomized controlled trial will recruit PwPD from 2 large, urban, academic medical centers. Participants (N = 250 PwPD) will be randomized to (1) home-based aerobic exercise or (2) usual and customary care. Those in the aerobic exercise 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 usual and customary care 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 the MDS-UPDRS III. Clinical and biomechanical measures will also be used to assess upper and lower extremity motor function as well as non-motor functions. IMPACT: Should long-term aerobic exercise demonstrate disease-modifying capability, this study will provide evidence that "Exercise is Medicine" for PwPD. Further, the derived prognostic model will inform a patient-specific exercise prescription for PwPD and expected effects on PD progression.
Authors: Allison L Amateis; Chelsea L Boesel; Bryan P Ehnert; Abby S Evans; Katheryn E Hurst; Katie L Marek; Amanda C Sullivan; Kathryn R Zalewski; Wendy E Huddleston Journal: Physiother Theory Pract Date: 2018-05-23 Impact factor: 2.279
Authors: Hélcio Kanegusuku; Carla Silva-Batista; Tiago Peçanha; Alice Nieuwboer; Natan D Silva; Luiz A Costa; Marco T de Mello; Maria E Piemonte; Carlos Ugrinowitsch; Cláudia L Forjaz Journal: Arch Phys Med Rehabil Date: 2016-01-09 Impact factor: 3.966
Authors: Paul A Harris; Robert Taylor; Brenda L Minor; Veida Elliott; Michelle Fernandez; Lindsay O'Neal; Laura McLeod; Giovanni Delacqua; Francesco Delacqua; Jacqueline Kirby; Stephany N Duda Journal: J Biomed Inform Date: 2019-05-09 Impact factor: 6.317
Authors: Sarah J Ozinga; Andre G Machado; Mandy Miller Koop; Anson B Rosenfeldt; Jay L Alberts Journal: Mov Disord Date: 2015-03-25 Impact factor: 10.338
Authors: Beth E Fisher; Giselle M Petzinger; Kerry Nixon; Elizabeth Hogg; Samuel Bremmer; Charles K Meshul; Michael W Jakowec Journal: J Neurosci Res Date: 2004-08-01 Impact factor: 4.164
Authors: Byron Lai; Jeffer E Sasaki; Brenda Jeng; Katie L Cederberg; Marcas M Bamman; Robert W Motl Journal: JMIR Rehabil Assist Technol Date: 2020-01-16