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Study in Parkinson’s disease of exercise phase 3 (SPARX3): study protocol for a randomized controlled trial

2022; Springer Science+Business Media; Volume: 23; Issue: 1 Linguagem: Inglês

10.1186/s13063-022-06703-0

1745-6215

Charity G. Patterson, Elizabeth Joslin, Alexandra B. Gil, Wendy A. Spigle, Todd Nemet, Lana M. Chahine, Cory L. Christiansen, Ed Melanson, Wendy M. Kohrt, Martina Mancini, Deborah A. Josbeno, Katherine Balfany, Garett Griffith, Mac Kenzie Dunlap, Guillaume Lamotte, Erin Suttman, Danielle Larson, Chantale Branson, Kathleen McKee, Li Goelz, Cynthia Poon, Barbara C. Tilley, Un Jung Kang, Malú G. Tansey, Nijee Luthra, Caroline M. Tanner, Jacob M. Haus, Giamila Fantuzzi, Nikolaus R. McFarland, Paulina González-Latapí, Tatiana Foroud, Robert W. Motl, Michael A. Schwarzschild, Tanya Simuni, Kenneth Marek, Anna Naito, Codrin Lungu, Daniel M. Corcos, Terry D. Ellis, Ludy C. Shih, Timothy Nordahl, Michael Stevenson, Jay L. Alberts, Ashwini K. Rao, Corey Landis, Joe Nocera, Madeleine E. Hackney, Elizabeth L. Stegemöller, Angela L. Ridgel, Jan M. Hondzinski, Neil M. Johannsen, Patrick S. Drummond, Heather Milton, David A. Hinkle, Fay B. Horak, Mitra Afshari, Christopher P. Hurt, Ariel Kidwell-Chandler, Corinna Conroy, Neil Panchal, Brooke Schultz, Jes Marchbank, Aaron Bloemer, Demetra D. Christou, David E. Vaillancourt, Stephanie Lapierre, Colum D. MacKinnon, Sommer L. Amundsen Huffmaster, Kristin K. Garland, Blake B. Rasmussen, Summer Chapman, Jessica Spahn, Laura Wu, Leland E. Dibble, Geneviève N. Olivier, Arthur Weltman, W. Alex Dalrymple, David A. Edwards, Corey A. Rynders, Lauren E. Miller, Gammon M. Earhart, Kerri S. Rawson, Kelvin E. Jones, Krista Nelles, Quincy J. Almeida, Marie Saint‐Hilaire, Stewart A. Factor, Camilla Kilbane, Brian Copeland, Marian L. Dale, Alberto J. Espay, Adolfo Ramirez‐Zamora, Amanda Fessenden, Andres Deik, Richard Camicioli,

Muscle activation and electromyography studies

Abstract Background To date, no medication has slowed the progression of Parkinson’s disease (PD). Preclinical, epidemiological, and experimental data on humans all support many benefits of endurance exercise among persons with PD. The key question is whether there is a definitive additional benefit of exercising at high intensity, in terms of slowing disease progression, beyond the well-documented benefit of endurance training on a treadmill for fitness, gait, and functional mobility. This study will determine the efficacy of high-intensity endurance exercise as first-line therapy for persons diagnosed with PD within 3 years, and untreated with symptomatic therapy at baseline. Methods This is a multicenter, randomized, evaluator-blinded study of endurance exercise training. The exercise intervention will be delivered by treadmill at 2 doses over 18 months: moderate intensity (4 days/week for 30 min per session at 60–65% maximum heart rate) and high intensity (4 days/week for 30 min per session at 80–85% maximum heart rate). We will randomize 370 participants and follow them at multiple time points for 24 months. The primary outcome is the Movement Disorders Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) motor score (Part III) with the primary analysis assessing the change in MDS-UPDRS motor score (Part III) over 12 months, or until initiation of symptomatic antiparkinsonian treatment if before 12 months. Secondary outcomes are striatal dopamine transporter binding, 6-min walk distance, number of daily steps, cognitive function, physical fitness, quality of life, time to initiate dopaminergic medication, circulating levels of C-reactive protein (CRP), and brain-derived neurotrophic factor (BDNF). Tertiary outcomes are walking stride length and turning velocity. Discussion SPARX3 is a Phase 3 clinical trial designed to determine the efficacy of high-intensity, endurance treadmill exercise to slow the progression of PD as measured by the MDS-UPDRS motor score. Establishing whether high-intensity endurance treadmill exercise can slow the progression of PD would mark a significant breakthrough in treating PD. It would have a meaningful impact on the quality of life of people with PD, their caregivers and public health. Trial registration ClinicalTrials.gov NCT04284436. Registered on February 25, 2020.