The ParkCycle Study
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 30 - 75 |
| Updated: | 2/7/2015 |
| Start Date: | January 2012 |
| End Date: | March 2013 |
The ParkCycle Study: Effects of Aerobic Exercise on Cognitive and Adaptive Plasticity in Parkinson's Disease
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.
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.
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
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