학술논문

Study in Parkinson’s disease of exercise phase 3 (SPARX3): study protocol for a randomized controlled trial
Document Type
article
Source
Trials. 23(1)
Subject
Health Sciences
Sports Science and Exercise
Neurosciences
Clinical Trials and Supportive Activities
Aging
Cardiovascular
Rehabilitation
Prevention
Clinical Research
Brain Disorders
Parkinson's Disease
Neurodegenerative
Heart Disease
Evaluation of treatments and therapeutic interventions
6.1 Pharmaceuticals
6.7 Physical
Neurological
Antiparkinson Agents
Brain-Derived Neurotrophic Factor
C-Reactive Protein
Clinical Trials
Phase III as Topic
Dopamine Plasma Membrane Transport Proteins
Exercise
Exercise Therapy
Humans
Multicenter Studies as Topic
Parkinson Disease
Quality of Life
Randomized Controlled Trials as Topic
Treatment Outcome
Parkinson disease
Endurance exercise
Treadmill exercise
Exercise dose response
DaTscan (TM) SPECT
Gait assessment
Quality of life
Time to initiate dopaminergic medication
Blood biomarkers
SPARX3-PSG Investigators
DaTscan™ SPECT
Cardiorespiratory Medicine and Haematology
Clinical Sciences
Cardiovascular System & Hematology
General & Internal Medicine
Clinical sciences
Epidemiology
Health services and systems
Language
Abstract
BackgroundTo 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.MethodsThis 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.DiscussionSPARX3 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 registrationClinicalTrials.gov NCT04284436 . Registered on February 25, 2020.