Clinical trial NCT01562496: The ParkCycle Study: Aerobic Exercise in PD
Official title: The ParkCycle Study: Effects of Aerobic Exercise on Cognitive and Adaptive Plasticity in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Neuroprotective
Intensive exercise
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
First posted: 2012-03-23
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Trails A and B task
timeFrame: every month for 6-7 months
Secondary outcomes:
measure: UPDRS
timeFrame: baseline and after 6 months follow-up (FU)
measure: Cognitive tests
timeFrame: baseline and after 6 months FU
measure: Kinetics tests
timeFrame: baseline and after 6 months FU
measure: questionaires
timeFrame: baseline and after 6 months FU
measure: maximal exercise test
timeFrame: baseline and after 6 months FU
measure: feasibility parameters
timeFrame: after 6 months (termination of intervention)
measure: neuroplasticity
timeFrame: baseline and after 6 months FU
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland clinic
state: Ohio
city: Nijmegen
country: Netherlands
facility: UMC St Radboud
Study officials:
affiliation: Radboud University Medical Center
name: Bas Bloem, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: