Thank you for your interest in the SPARX3 study. We are actively recruiting participants for this ongoing study. Below is more information for volunteering in SPARX3.
Approximately 29 sites will enroll participants: 27 sites that cover all geographic regions of the USA and 2 sites in Canada. All sites will have a collaboration between movement disorders and exercise specialists. The sites have extensive experience conducting studies involving exercise and people with Parkinson's disease (PD).
What is SPARX3 about?
SPARX3 (NCT04284436) is a Phase 3 multi-site, randomized study of endurance treadmill exercise on changes in the signs and symptoms of PD. The goal of SPARX3 is to test whether the progression of the signs of PD is decreased in people who have not initiated medication for PD when they perform endurance treadmill exercise. 370 persons diagnosed with PD who have not yet initiated medication, age 40-80 years, will be randomly assigned to either moderate-intensity or high-intensity exercise training.
What are the research study procedures?
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.
Who qualifies to volunteer in the SPARX3 study?
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
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
Canadian Sites 28. University of Alberta29. Wilfrid Laurier University