The National Institutes of Health (NIH) has awarded Cleveland Clinic researcher Jay Alberts, PhD, a five-year, $3 million grant to conduct a two-site clinical trial to assess potential disease-altering effects of long-term, high-intensity, home-based aerobic exercise in Parkinson disease (PD).
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“Effective disease-modifying therapy for patients with PD remains elusive,” says Dr. Alberts, Vice Chair of Innovation in Cleveland Clinic’s Neurological Institute and a staff member in the Department of Biomedical Engineering. “Exercise is accepted as adjunctive treatment for PD, but its disease-altering properties are unclear. The work funded by this award will be the first long-term investigation of the potential for aerobic exercise to arrest disease progression.”
Building on prior work
High-intensity exercise has been shown to yield neuroprotective effects and improve motor functioning in animal models of PD. Moreover, Dr. Alberts’ group has reported promising translational work in humans with PD, leading up to the recently completed 100-subject CYCLE trial (CYClical Lower Extremity Exercise for Parkinson’s; NCT01636297), which also was supported by the NIH.
Results of that study, for which Dr. Alberts served as principal investigator, showed that eight weeks of aerobic exercise on a stationary recumbent bicycle in a controlled laboratory setting significantly improved global motor function and specific aspects of gait and cognitive function in individuals with PD. Results in the full 100-patient cohort were presented in a May 29 platform presentation at the 2019 Annual Meeting of the American College of Sports Medicine. Results in a subset of 59 patients were published online by the Journal of the Neurological Sciences earlier this year, showing that eight weeks of high-intensity aerobic training significantly enhanced overall functional mobility.
“These positive outcomes provide a strong rationale for studying the effectiveness of a long-term CYCLE protocol in a home-based setting to impact a greater number of people with PD,” Dr. Alberts explains. “In addition to exploring whether exercise can slow disease progression, our new study aims to assess how well this laboratory-based protocol is translated to patients’ homes.”
250 patients randomized to 12 months of exercise or usual care
For the new study, Cleveland Clinic and University of Utah researchers will recruit 250 individuals with PD and randomize them to either high-intensity home exercise or usual and customary care (UCC). Patients in the exercise group will use indoor cycling bikes from the fitness technology company Peloton and follow the CYCLE trial’s exercise protocol three times a week for 12 months. Patients in the UCC group will be instructed to engage in their normal activities.
The two groups will undergo identical blinded motor and non-motor evaluation protocols at enrollment and at six and 12 months. In addition to assessment with the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) III, patients will have motor and non-motor skills systematically quantified via the PD Performance Test, a validated collection of biomechanical-based iPad applications developed in Dr. Alberts’ lab. Overall activity levels will be monitored for both groups via a wearable sensor.
In search of a predictive model
“Combining clinical and biomechanical measures of motor and cognitive function will accelerate our understanding of potential mechanisms underlying positive effects of exercise on disease progression,” Dr. Alberts explains.
He adds that exercise performance data will be gathered to monitor exercise adherence and to build an exercise response predictive model. “We hope the model will facilitate a transition from general recommendations to patient-specific exercise prescriptions for which potential outcomes can be estimated,” he concludes.