Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 256
- Locations
- 2
- Primary Endpoint
- Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) will be conducted by a consistent rater, blinded as to participant randomization group.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
High-Intensity Exercise Group
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.
Intervention: High-Intensity Aerobic Exercise (AE) (Other)
Usual and Customary Care Group
Mild to moderate Parkinson's disease patients, receiving no exercise intervention through the research but monitored with a parallel attention control. They will continue to receive usual and customary care for their Parkinson's disease during the 12 month period.
Intervention: Usual and Customary Care (UCC) (Other)
Outcomes
Primary Outcomes
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score
Time Frame: Baseline, 6 months, 12 months
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination score, measured off medication. Range of scores is 0 to 132, with lower score indicating better motor function.
Secondary Outcomes
- 10 Meter Walk Test (10MWT) Comfortable Pace Velocity(Baseline, 6 months, 12 months)
- 10 Meter Walk Test (10MWT) Fast Pace Velocity(Baseline, 6 months, 12 months)
- Timed Up and Go (TUG) Test Duration(Baseline, 6 months, 12 months)
- Timed Up and Go (TUG) Test Turning Velocity(Baseline, 6 months, 12 months)
- Manual Dexterity Test Completion Time(Baseline, 6 months, 12 months)
- Processing Speed Test Match Score(Baseline, 6 months, 12 months)
- Trail Making Test (TMT) B to A Duration Ratio(Baseline, 6 months, 12 months)
- Visual Memory Test Symbol Recall Score(Baseline, 6 months, 12 months)
Investigators
Jay Alberts
Principal Investigator
The Cleveland Clinic