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Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3

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Description

Aerobic exercise is a vital treatment for people living with Parkinson's disease. Although anti-parkinsonian medication helps alleviate Parkinson's symptoms, it is not known to slow the rate of disease progression. Aerobic exercise is a treatment with the most compelling evidence for its potential to slow Parkinson's disease progression. While both moderate- and high-intensity aerobic exercise provide health benefits, it is currently unclear which intensity is more effective for people with Parkinson’s. The SPARX3 (NCT04284436) study is the first randomized control trial designed to investigate the effects of moderate- and high-intensity aerobic exercise on disease progression in untreated patients with Parkinson's. First, you will complete a telephone screening followed by two in-person screening visits to confirm that you meet the criteria to participate in the study. These visits consist of physical and memory/thinking assessments, a blood draw, a questionnaire to screen for depression, and a brain scan (DaTscan) that helps confirm diagnosis of PD. If you are eligible to participate in this study, you will then complete 7 additional assessment visits over the course of the 24 months, which consist of more physical and memory/thinking assessments, questionnaires, blood draws, exercise tests, and one additional brain scan. You will be randomized (like flipping a coin) to one of two exercise groups. You will be asked to exercise at a specific rate/intensity 4 days per week for approximately 30 min. What will volunteers be asked to do? Physical and cognitive assessments Blood draws at the start and end of the study Imaging scans (DaTscan) 18 months of treadmill exercise Regularly scheduled in-person study visits over 24 months During this study, participants will be encouraged: To refrain from enrolling in other studies or interventions that could affect your motor symptoms or aerobic fitness, but can continue to engage in their usual physical activities. To refrain from enrolling in other studies that require a DaTscan™ SPECT imaging procedure as part of the study activities, with the exception of the PPMI2.0 study. To refrain from taking dopaminergic medication unless medically necessary for the duration of the study

Details
Age

Adult

Eligibility

We are seeking individuals with PD who are willing to take part in regular treadmill exercise program 4x/week for 18 months and participate in study visits periodically for 24 months. Volunteers must be: 40-80 years old Diagnosed with PD within the last 3 years Not yet taking medications for PD symptoms Not planning to start medications for PD symptoms in the next 6 months Not currently participating in a structured exercise program

Inclusion Criteria * Primary PD diagnosed using UK Brain Bank Criteria (< 3 years since diagnosis) * Age 40-80 years * Hoehn and Yahr stage less than 3 Exclusion Criteria * Not currently treated with dopaminergic therapies or expected to require such treatment within next 6 months * Use of PD medication within past 60 days * Poorly controlled or unstable cardiovascular, metabolic, or renal disease * Hypertension, hypo- or hyperthyroidism, and/or abnormal renal function * Disorders that interfere with ability to perform endurance exercises * Regular participation in vigorous endurance exercise * MoCA score <26, BDI score >16 * Prior SPECT scan within past 6 months * Allergy to iodinated products/hypersensitivity to DaTscan™ SPECT * Women who are pregnant or plan to become pregnant in next 12 months

Type of Study

Outcomes Research

Locations

Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Cory Christiansen,  PhD

Cory Christiansen, PhD

Study ID

Protocol Number: 20-1854

More information available at ClinicalTrials.gov: NCT04284436

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