The ParkCycle Study
The primary goal of this study is to determine the neuroprotective qualities of long-term, in home, exercise therapy program in human PD patients. It is hypothesized that an exercise intervention might delay the onset of levo-dopa therapy (i.e. evidence for neuroprotection). The first part involves a pilot-study in which the feasibility of the intervention and outcome measures will be tested.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The ParkCycle Study: Effects of Aerobic Exercise on Cognitive and Adaptive Plasticity in Parkinson's Disease|
- Trails A and B task [ Time Frame: every month for 6-7 months ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]
- Cognitive tests [ Time Frame: baseline and after 6 months FU ] [ Designated as safety issue: No ]MMSE and SCOPA-org
- Kinetics tests [ Time Frame: baseline and after 6 months FU ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]to determine training load and subject fitness
- feasibility parameters [ Time Frame: after 6 months (termination of intervention) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- 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.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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
Twenty patients (10 at each site) will be listed as a control group and will be instructed to continue their previous level of activity throughout the study
Neuroprotective therapy (i.e. therapy that slows the disease process) is an unmet medical need in Parkinson's disease (PD). Animal studies have shown that 'intensive' exercise improves motor function and may have neuroprotective properties. The promising animal results have not been translated to patients with PD so far. This is a two-cluster randomised control trial in which twenty patients (10 at each site) will undergo a 6-month exercise intervention on a stationary virtual reality bike and twenty patients (10 at each site)will serve as controls.
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Amanda Penko, M.A. 216-636-9717 firstname.lastname@example.org|
|Contact: Elizabeth A Jansen +1216 635 3866 email@example.com|
|Principal Investigator: Jay L Alberts, MD PhD|
|Sub-Investigator: Amanda Penko, M.A.|
|Sub-Investigator: Anwar Ahmed, MD|
|Sub-Investigator: Gordon G Blackburn, PhD|
|Sub-Investigator: Elizabeth A Jansen|
|UMC St Radboud||Recruiting|
|Nijmegen, Netherlands, 6500HB|
|Contact: Nicolien M van der Kolk, MD +3124316600 firstname.lastname@example.org|
|Contact: Maarten Nijkrake, PhD +31243615202 M.Nijkrake@reval.umcn.nl|
|Principal Investigator: Bas R Bloem, MD, PhD|
|Sub-Investigator: Maarten J Nijkrake, PhD|
|Sub-Investigator: Nicolien M van der Kolk, MD|
|Sub-Investigator: Maria Hopman, MD, PhD|
|Sub-Investigator: Ivan Toni, PhD|
|Sub-Investigator: George Borm, PhD|
|Sub-Investigator: Marten Munneke, PhD|