Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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Overview of Experimental Design: The study is a randomized controlled clinical trial designed to examine the disease-altering capabilities of a 12 month aerobic exercise program for individuals with PD. A total of 252 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 a commercially available Peloton 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. Both groups will undergo a series of motor and non-motor assessments at enrollment, 6 months, and 12 months to measure disease progression of the 12 month period. Additionally, data will be used to develop a prognostic model to predict 12-month change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale III (MDS-UPDRS III) for patients participating in a home-based high-intensity aerobic exercise program.

Official Title
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Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: High-Intensity Aerobic Exercise


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 256 mild to moderate PD patients will be randomized into a high-intensity home exercise group or a Usual and Customary Care group (no exercise control group).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-Intensity Exercise Group<br>Mild to moderate Parkinson's disease patients: The exercise group will be asked to cycle 3x/week for 12 months on a Peloton bicycle which will be delivered to their home. | Other: High-Intensity Aerobic Exercise<br>* The home-based exercise group will receive a Peloton indoor cycle delivered to their home and a heart rate monitor strap. Participants will be asked to cycle 3x/week for 12 months on their bike with their heart rate monitor at an aerobic intensity between 60-80% of heart rate reserve with a target cadence between 80-90 revolutions per minute (RPMs). Additionally, participants (both groups) will receive activity monitors to monitor their daily activity levels.<br>|
| No Intervention: Usual and Customary Care Group<br>Mild to moderate Parkinson's disease patients, receiving no exercise intervention through the research. They will continue to receive usual and customary care for their Parkinson's disease during the 12 month period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise