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Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04000360
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : April 10, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jay Alberts, The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: High-Intensity Aerobic Exercise Phase 2 Phase 3

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 250 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 250 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 (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.
Primary Purpose: Treatment
Official Title: Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease
Actual Study Start Date : November 13, 2019
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine


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.
Other: High-Intensity Aerobic Exercise
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000360


Contacts
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Contact: Elizabeth A Jansen, MPH 216-445-3866 jansena@ccf.org
Contact: Anson Rosenfeldt, DPT 216-445-3277 rosenfa2@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Elizabeth A Jansen, MPH    216-445-3866    jansena@ccf.org   
Contact: Anson B Rosenfeldt, DPT    216-445-3277    rosenfa2@ccf.org   
Principal Investigator: Jay L Alberts, PhD         
Sponsors and Collaborators
The Cleveland Clinic
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Jay L Alberts, PhD The Cleveland Clinic
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Responsible Party: Jay Alberts, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04000360    
Other Study ID Numbers: 2R01NS073717-06A1 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jay Alberts, The Cleveland Clinic:
Exercise
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases