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NCT Number: NCT01562496

The ParkCycle Study: Aerobic Exercise in PD

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMC St Radboud, Nijmegen, Netherlands

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About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. UPDRS

    Time frame: baseline and after 6 months follow-up (FU)

  2. Cognitive tests

    Time frame: baseline and after 6 months FU

    MMSE and SCOPA-org

  3. 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

  4. 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.

  5. maximal exercise test

    Time frame: baseline and after 6 months FU

    to determine training load and subject fitness

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • The Cleveland Clinic

Registry information

Official study title

The ParkCycle Study: Effects of Aerobic Exercise on Cognitive and Adaptive Plasticity in Parkinson's Disease

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 23, 2012
Registry last updated
Nov 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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