Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT04000360|
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : April 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Other: High-Intensity Aerobic Exercise||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|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 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.|
|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|
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.
- 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.
- 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.
- 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.
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
|Contact: Elizabeth A Jansen, MPHfirstname.lastname@example.org|
|Contact: Anson Rosenfeldt, DPTemail@example.com|
|Principal Investigator:||Jay L Alberts, PhD||The Cleveland Clinic|