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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
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Radboud University

Tracking Information
First Submitted Date  ICMJE March 19, 2012
First Posted Date  ICMJE March 23, 2012
Last Update Posted Date November 13, 2014
Study Start Date  ICMJE January 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
  • 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 ]
    1. 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.
    2. 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The ParkCycle Study: Aerobic Exercise in PD
Official Title  ICMJE The ParkCycle Study: Effects of Aerobic Exercise on Cognitive and Adaptive Plasticity in Parkinson's Disease
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Behavioral: Exercise
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).
Study Arms  ICMJE
  • Experimental: Exercise
    Twente patients will perform Aerobic exercise 3 times a week for at least 30 min
    Intervention: Behavioral: Exercise
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2014)
35
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2012)
40
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of idiopathic Parkinson's disease according to the UK Queen Square Brain Bank Criteria
  • Hoehn & Yahr disease stages I-II
  • Age between 30 and 75 years
  • Having insufficient physical activity according to the ACSM guideline for adults, 50-64 years old with a chronic condition
  • Untreated with anti-parkinsonian medication or receiving medication, for less than two years, medication-responsive without fluctuations.

Exclusion Criteria:

  • Unclear diagnosis with Red Flags
  • Advanced problems in cognitive functioning: Mini Mental State Examination (MMSE)19 score < 24
  • Serious co-morbidity: neurological or orthopedic disorder that severely affects movement; known by specialist or medical practitioner
  • Pulmonary diseases; known by specialist or medical practitioner
  • Stroke
  • High risk of cardiovascular complications:

    • Hypertension (systole >150 and diastole > 100)
    • Diabetes Mellitus; known by specialist or medical practitioner
    • Cardiac valve defect (especially aortic valve stenosis); known by specialist or medical practitioner
    • Cardiac rhythm disorder; known by specialist or medical practitioner
    • Heart failure; known by specialist or medical practitioner
  • Use of ß-blockers
  • Not able to complete American (for Cleveland site) or Dutch questionnaires (for the Nijmegen site)
  • Daily institutionalized care
  • Contra-indications for fMRI:

    • Pregnancy
    • Metallic implants or electronic devices
    • Previous seizure
    • Claustrophobia
    • Not able to keep the head still for longer period, i.e. due to severe head tremor
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01562496
Other Study ID Numbers  ICMJE NL38116.091.11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE The Cleveland Clinic
Investigators  ICMJE
Principal Investigator: Bas Bloem, MD PhD Radboud University
PRS Account Radboud University
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP