The ParkCycle Study: Aerobic Exercise in PD

• ClinicalTrials.gov Identifier: NCT01562496
• Recruitment Status: Completed
• First Posted: March 23, 2012
• Last Update Posted: November 13, 2014
• Sponsor: Radboud University
• Collaborator: The Cleveland Clinic
• Information provided by (Responsible Party): Radboud University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease	Behavioral: Exercise	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The ParkCycle Study: Effects of Aerobic Exercise on Cognitive and Adaptive Plasticity in Parkinson's Disease
• Study Start Date: January 2012
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: October 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Exercise; Twente patients will perform Aerobic exercise 3 times a week for at least 30 min	Behavioral: Exercise; 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).
No Intervention: Control; Fifteen patients will be listed as a control group and will be instructed to continue their previous level of activity throughout the study

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]
   1. 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.
   2. 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.

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Ohio

Cleveland clinic

Cleveland, Ohio, United States, 44195

Netherlands

UMC St Radboud

Nijmegen, Netherlands, 6500HB

Sponsors and Collaborators

Radboud University

The Cleveland Clinic

Investigators

• Principal Investigator: Bas Bloem, MD PhD; Radboud University

More Information

• Responsible Party: Radboud University
• ClinicalTrials.gov Identifier: NCT01562496
• Other Study ID Numbers: NL38116.091.11
• First Posted: March 23, 2012
• Last Update Posted: November 13, 2014
• Last Verified: November 2014

Keywords provided by Radboud University:

Parkinson's disease; Neuroprotective; Intensive exercise

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases