The ParkCycle Study: Aerobic Exercise in PD

Radboud University Medical Center

Status: Completed

Conditions: Parkinson's Disease

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01562496

NL38116.091.11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Exercise

Experimental group

Description:

Twente patients will perform Aerobic exercise 3 times a week for at least 30 min

Treatment:

Behavioral: Exercise

Control

No Intervention group

Description:

Fifteen patients will be listed as a control group and will be instructed to continue their previous level of activity throughout the study