The ParkCycle Study: Aerobic Exercise in PD
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.
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.
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