SPARX3 study of treadmill exercise for Parkinson’s recruiting at 24 sites
Trial testing effects of moderate- and high-intensity aerobic exercise
SPARX3, an ongoing clinical trial investigating the effects of moderate– and high-intensity aerobic exercise — specifically, treadmill walking four times per week — in Parkinson’s disease, is still recruiting patients at 23 sites in the U.S. and one in Canada, according to the trial’s website.
The Phase 3 study, which spans two years, is now enrolling patients, ages 40 to 80, to test the impact of aerobic exercise on Parkinson’s disease progression.
Launched in 2021 and headed by principal investigator Daniel Corcos, PhD, a professor at Northwestern University’s Feinberg School of Medicine, in Chicago, the SPARX3 trial (NCT04284436) expects to recruit 370 patients with recently diagnosed Parkinson’s who haven’t yet started on any medication.
“The question we want to answer is whether there is a benefit to exercising at the higher intensity in terms of slowing down the rate at which (Parkinson’s) disease progresses,” Corcos said in a Northwestern Medicine article, according to a university press release.
Parkinson’s patients in trial will exercise with treadmill walking for 18 months
Participants in the study, who must have a disease duration shorter than three years, will be randomly assigned to 18 months of treadmill exercise, for 30 minutes four times per week.
This aerobic workout will be done either at high intensity — to keep patients’ heart rates at 80% to 85% of maximum — or at moderate intensity, with a target of 60% to 65% of maximum heart rate.
After the 18 months, patients will be followed for another six months, for a total of two years, to test their ability to sustain exercise independently, according to the press release.
Parkinson’s causes a range of motor symptoms that can worsen over time, making it difficult for patients to walk, move, and carry out daily activities. Regular exercise, including resistance, balance, and endurance training, can help patients maintain mobility.
Endurance training, which shapes the ability to sustain physical exercise for some time, may ease typically progressing symptoms in Parkinson’s caused by a lack of the signaling chemical dopamine in the brain. Exercising at a higher intensity could perhaps provide even more benefits by boosting dopaminergic signaling, according to researchers.
Earlier SPARX study showed benefits only with high-intensity aerobic workout
The earlier Phase 2 clinical trial SPARX (NCT01506479), also led by Corcos, showed that exercise on a treadmill three times per week at high intensity, but not at moderate intensity, slowed the rate at which Parkinson’s would have progressed over six months.
The main goal of SPARX3 is to confirm whether high-intensity exercise works better than moderate-intensity exercise at slowing the rate at which Parkinson’s progresses, by watching for changes in motor symptoms measured using the Movement Disorders Society–Unified Parkinson Disease Rating Scale at 12 months.
“While both moderate- and high–intensity aerobic exercise provides health benefits, it is currently unclear which intensity is more effective for people with Parkinson’s,” the trial’s website states.
Secondary outcome measures include changes in motor symptoms at 18 months as well as changes in dopaminergic signaling, walking capacity, cognitive function, and quality of life at both one year and 18 months. Researchers also will measure the time to patients starting dopaminergic medication, as well as its dose.
An exploratory goal is to test whether high-intensity exercise may continue to slow the rate at which Parkinson’s progresses after two years — that is, six months after supervised treadmill walking is stopped and patients begin to exercise independently.
This clinical trial, sponsored by Northwestern University, is being supported by the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health.
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