The ParkCycle Study: Aerobic Exercise in PD

Not Applicable

Completed

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Twente patients will perform Aerobic exercise 3 times a week for at least 30 min

Primary Outcome Measures

Name	Time	Method
Trails A and B task	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

Name	Time	Method
UPDRS	baseline and after 6 months follow-up (FU)
Cognitive tests	baseline and after 6 months FU	MMSE and SCOPA-org
Kinetics tests	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
questionaires	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.
maximal exercise test	baseline and after 6 months FU	to determine training load and subject fitness
feasibility parameters	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.
neuroplasticity	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.

Locations (2): Cleveland clinic
🇺🇸
Cleveland, Ohio, United States
UMC St Radboud
🇳🇱
Nijmegen, Netherlands