The ParkCycle Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The Cleveland Clinic
The Davis Phinney Foundation
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01562496
First received: March 19, 2012
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Parkinson's Disease
Behavioral: Exercise

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]
    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.


Estimated Enrollment: 40
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)
Arms Assigned Interventions
Experimental: Exercise 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).
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562496

Locations
United States, Ohio
Cleveland clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Amanda Penko, M.A.    216-636-9717    penkoa@ccf.org   
Contact: Elizabeth A Jansen    +1216 635 3866    jansena@ccf.org   
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         
Netherlands
UMC St Radboud Recruiting
Nijmegen, Netherlands, 6500HB
Contact: Nicolien M van der Kolk, MD    +3124316600    parkcycle@neuro.umcn.nl   
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         
Sponsors and Collaborators
Radboud University
The Cleveland Clinic
The Davis Phinney Foundation
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01562496     History of Changes
Other Study ID Numbers: NL38116.091.11
Study First Received: March 19, 2012
Last Updated: March 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Radboud University:
Parkinson's disease
Neuroprotective
Intensive exercise

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 17, 2014