Parkinson Disease Clinical Trial
Official title:
Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease
Verified date | June 2023 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Identification of an effective disease-modifying intervention (e.g. pharmaceutical, surgical or behavioral) is an unmet need in Parkinson's disease (PD). Increasing evidence indicates high intensity aerobic exercise is a candidate to alter PD progression. The primary aim of this study is to examine the disease-altering capabilities of a long-term, high-intensity aerobic exercise intervention. A multi-site pragmatic randomized controlled trial design has been selected. Individuals with PD will be randomized into 1) a home-based aerobic exercise program, or 2) a usual and customary care (UCC). Subjects in the home exercise group will receive an indoor stationary bicycle delivered to their home for a 12 month exercise period. Individuals in the UCC group will continue their current level of physical activity. Motor and non-motor assessments will be conducted at the main campus of the Cleveland Clinic or the University of Utah at enrollment, 6 months, and 12 months. Each assessment will last approximately one hour.
Status | Completed |
Enrollment | 256 |
Est. completion date | April 30, 2023 |
Est. primary completion date | April 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult with a diagnosis of idiopathic PD by a physician or physician extender - Hoehn and Yahr stage I-III - Demonstrate the ability to safely mount and dismount the Peloton stationary cycle - In-home wireless network (WiFi; required for Peloton system exercise data transmission) Exclusion Criteria: - Participation in pharmaceutical or behavioral disease modifying PD-related clinical trial or study - Diagnosis of dementia or any neurocognitive impairment that compromises one's ability to provide informed consent - Implanted deep brain stimulation electrodes - If the American College of Sports Medicine (ACSM) screen recommends medical clearance, the subject must obtain medical clearance by their health care provider prior to participation. - Any musculoskeletal issue that would limit one's ability to engage in exercise - Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke) |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Processing Speed Test | Change in score for the Processing Speed Test Score will be compared between exercise arm and UCC group. The score is the number of correct responses over a two minute testing time. Higher scores indicate improvements in processing speed. | Baseline (on and off medications), 6 months (off medications), 12 months (off medication) | |
Primary | MDS-UPDRS III Motor Score | Change in MDS-UPDRS III Motor Score will be compared between the exercise arm and the UCC group . Administered by a blinded rater, used to examine global motor function and disease severity. The change in Motor Score from the MDS-UPDRS III will be utilized. A lower score indicates improvements in motor function. | Baseline (on and off medications), 6 months (off medications), 12 months (off medication) | |
Secondary | Nine Hole Peg Test | Change in overall time for the Nine Hole Peg Test Score will be compared between exercise arm and UCC group. Faster time (measured in milliseconds) at the conclusion of the intervention indicates improvements in manual dexterity. | Baseline (on and off medications), 6 months (off medications), 12 months (off medication) |
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