The ParkCycle Study: Aerobic Exercise in PD - Full Text View

Purpose

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	Intervention
Parkinson's Disease	Behavioral: Exercise


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The ParkCycle Study: Effects of Aerobic Exercise on Cognitive and Adaptive Plasticity in Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Exercise and Physical Fitness Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:

Trails A and B task [ Time Frame: every month for 6-7 months ] [ Designated as safety issue: No ]
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:

UPDRS [ Time Frame: baseline and after 6 months follow-up (FU) ] [ Designated as safety issue: No ]
Cognitive tests [ Time Frame: baseline and after 6 months FU ] [ Designated as safety issue: No ]
MMSE and SCOPA-org
Kinetics tests [ Time Frame: baseline and after 6 months FU ] [ Designated as safety issue: No ]
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
questionaires [ Time Frame: baseline and after 6 months FU ] [ Designated as safety issue: No ]
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.
maximal exercise test [ Time Frame: baseline and after 6 months FU ] [ Designated as safety issue: No ]
to determine training load and subject fitness
feasibility parameters [ Time Frame: after 6 months (termination of intervention) ] [ Designated as safety issue: No ]
Compliance based on the number of completed exercise sessions and the amount of time that patients exercised at their target heart rate.
neuroplasticity [ Time Frame: baseline and after 6 months FU ] [ Designated as safety issue: No ]
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.


Enrollment:	35
Study Start Date:	January 2012
Study Completion Date:	October 2014
Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


Ages Eligible for Study:	30 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562496

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 History of Changes
Other Study ID Numbers:	NL38116.091.11
Study First Received:	March 19, 2012
Last Updated:	November 12, 2014
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 27, 2016