- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04000360
Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease
June 27, 2023 updated by: Jay Alberts, The Cleveland Clinic
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
256
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
No Intervention: Usual and Customary Care Group
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?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MDS-UPDRS III Motor Score
Time Frame: Baseline (on and off medications), 6 months (off medications), 12 months (off medication)
|
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
Time Frame: Baseline (on and off medications), 6 months (off medications), 12 months (off medication)
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Processing Speed Test
Time Frame: Baseline (on and off medications), 6 months (off medications), 12 months (off medication)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jay L Alberts, PhD, The Cleveland Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 13, 2019
Primary Completion (Actual)
April 30, 2023
Study Completion (Actual)
April 30, 2023
Study Registration Dates
First Submitted
June 25, 2019
First Submitted That Met QC Criteria
June 26, 2019
First Posted (Actual)
June 27, 2019
Study Record Updates
Last Update Posted (Actual)
June 28, 2023
Last Update Submitted That Met QC Criteria
June 27, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2R01NS073717-06A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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