The ParkCycle Study: Aerobic Exercise in PD
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|ClinicalTrials.gov Identifier: NCT01562496|
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : November 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Behavioral: Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The ParkCycle Study: Effects of Aerobic Exercise on Cognitive and Adaptive Plasticity in Parkinson's Disease|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Twente patients will perform Aerobic exercise 3 times a week for at least 30 min
six-months long exercise intervention on a stationary virtual reality bike, 3-5 times a week, each session lasting 30-45 minutes at a target heart rate (60-85% heart rate reserve).
No Intervention: Control
Fifteen patients will be listed as a control group and will be instructed to continue their previous level of activity throughout the study
- Trails A and B task [ Time Frame: every month for 6-7 months ]this test requires subjects to connect numbers on a screen from 1 to 25 (part A) and to connect numbers to letters. This neuropsychological test has already been proven to be sensitive to frontal lobe damage (e.g. Boll 1981) and has been recognised as an outcome for executive function in PD21. This test is performed using an online system called i-COMET that allows subject to complete the task weekly at home. Subjects have to login at the i-COMET website (https://i-comet.com) with a username and password that is provided to them by the research team.
- UPDRS [ Time Frame: baseline and after 6 months follow-up (FU) ]
- Cognitive tests [ Time Frame: baseline and after 6 months FU ]MMSE and SCOPA-org
- Kinetics tests [ Time Frame: baseline and after 6 months FU ]Timed Up and Go Test (iTUG) and a postural sway test, , as an objective measure for balance and mobility Finger tap test as a measure for bradykinesia and a pegboard test as a measure for complex motor function
- questionaires [ Time Frame: baseline and after 6 months FU ]The PDQ-39 is a PD specific questionnaire including 39 items concerning quality of life. Other non-motor features such as mood and sleep are respectively measured using the HADS and SCOPA-Sleep.
- maximal exercise test [ Time Frame: baseline and after 6 months FU ]to determine training load and subject fitness
- feasibility parameters [ Time Frame: after 6 months (termination of intervention) ]Compliance based on the number of completed exercise sessions and the amount of time that patients exercised at their target heart rate.
- neuroplasticity [ Time Frame: baseline and after 6 months FU ]
- Volumetric brain changes: cerebral grey and white matter will be analyzed using Vox-Based Morphometry, a validated and fully automated technique for computational analysis of differences in global and local grey and/or white matter volume.
- Resting state brain perfusion: functional coupling between strial subregions and the cerebral cortex will be analyzed using multiple regression analyses on resting state functional MRI data.
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): NCT01562496
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|UMC St Radboud|
|Nijmegen, Netherlands, 6500HB|
|Principal Investigator:||Bas Bloem, MD PhD||Radboud University|