Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
High-Intensity Aerobic Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Exercise
Eligibility Criteria
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)
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
High-Intensity Exercise Group
Usual and Customary Care Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04000360
First Posted
June 25, 2019
Last Updated
June 27, 2023
Sponsor
The Cleveland Clinic
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT04000360
Brief Title
Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease
Official Title
Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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
Investigator
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.
Allocation
Randomized
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-Intensity Exercise Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual and Customary Care Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
High-Intensity Aerobic Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
MDS-UPDRS III Motor Score
Description
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.
Time Frame
Baseline (on and off medications), 6 months (off medications), 12 months (off medication)
Secondary Outcome Measure Information:
Title
Nine Hole Peg Test
Description
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.
Time Frame
Baseline (on and off medications), 6 months (off medications), 12 months (off medication)
Other Pre-specified Outcome Measures:
Title
Processing Speed Test
Description
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.
Time Frame
Baseline (on and off medications), 6 months (off medications), 12 months (off medication)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay L Alberts, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34363478
Citation
Alberts JL, Rosenfeldt AB, Lopez-Lennon C, Suttman E, Jansen AE, Imrey PB, Dibble LE. Effectiveness of a Long-Term, Home-Based Aerobic Exercise Intervention on Slowing the Progression of Parkinson Disease: Design of the Cyclical Lower Extremity Exercise for Parkinson Disease II (CYCLE-II) Study. Phys Ther. 2021 Nov 1;101(11):pzab191. doi: 10.1093/ptj/pzab191.
Results Reference
derived
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Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease
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