The ParkCycle Study: Aerobic Exercise in PD

Parkinson's Disease Clinical Trial

Official title:

The ParkCycle Study: Effects of Aerobic Exercise on Cognitive and Adaptive Plasticity in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562496
• Other study ID #: NL38116.091.11
• Status: Completed
• Phase: N/A
• First received: March 19, 2012
• Last updated: November 12, 2014
• Start date: January 2012
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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).

Locations

Country	Name	City	State
Netherlands	UMC St Radboud	Nijmegen
United States	Cleveland clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	The Cleveland Clinic

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trails A and B task	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.	every month for 6-7 months	No
Secondary	UPDRS		baseline and after 6 months follow-up (FU)	No
Secondary	Cognitive tests	MMSE and SCOPA-org	baseline and after 6 months FU	No
Secondary	Kinetics tests	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	baseline and after 6 months FU	No
Secondary	questionaires	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.	baseline and after 6 months FU	No
Secondary	maximal exercise test	to determine training load and subject fitness	baseline and after 6 months FU	No
Secondary	feasibility parameters	Compliance based on the number of completed exercise sessions and the amount of time that patients exercised at their target heart rate.	after 6 months (termination of intervention)	No
Secondary	neuroplasticity	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.; 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.	baseline and after 6 months FU	No