Exercise Neuroprotection in Parkinson's Disease
ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-85
SponsorUniversity of Nevada, Las Vegas
About this trial
The purpose of this study is to explore the relationships of exercise on inflammation in the body of older adults and people with Parkinson's disease (PD). This is important research for older adults but is especially important for people with PD because neuroinflammation is the main pathological mechanism that is responsible for neuron cell death in this neurodegenerative disease. As PD is a progressive disease, halting or slowing the degeneration is an important research target. Halting or slowing the disease progress is known as neuroprotection. Exercise is an attractive therapeutic treatment for people with PD as it has a lot of multi-systemic benefits, but also there is a lot of evidence to suggest that it helps improve symptoms and slow the progression of the disease. Exercise has been theorized to decrease inflammation and, therefore, has a lot of promise as a neuroprotective agent in slowing or halting the degeneration in PD. Unfortunately, there is not a lot of research that has looked into the effect of exercise on the biological processes of inflammation. Thus, the purpose of this study is to investigate the biological evidence that underlies the positive effect of exercise in people with PD.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
30-85 years old
Neurologist-diagnosed PD
Able to participate in 30 minutes of continuous moderate aerobic exercise with 2-3 short breaks per self-report.
30-85 years old
Disqualifiers
Diagnoses, identified by self-report, that would preclude exercise participation (e.g., heart arrhythmias, uncontrolled blood pressure, exercise-induced asthma).
Those not deemed ready for exercise participation. Participants will be screened for exercise participation using the Physical Activities Readiness Questionnaire + which is used as a screening tool for all ages to identify risk factors that would clear someone for participation in moderate physical exercise.
Those with dementia will be excluded because there are self-report questionnaires in this study. This will be identified using the Montreal Cognitive Assessment and a score at or below a 21. Participants with mild cognitive impairment and no impairment will be included.
Trial design
Design model
Crossover
Treatments tested in this trial
Aerobic exercise
Procedure/SurgeryThe intervention is exercise and there are no drugs or devices used in this trial. The exercise consists of two intensity levels of a 30-minute aerobic exercise intervention with both arms crossing over to both conditions: low intensity exercise (60-70% of estimated maximum heart rate (EMRH)) and moderate-vigorous intensity exercise (75-85% of EMHR).
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Parkinson DiseaseActive comparator 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Exercise and inflammatory milieu
International Physical Activity Questionnaire (IPAQ) and blood serum levels of the following: interleukin-6 (IL-6), tumor necrosis factor alpha (TNF), interleukin-1β (IL-1β), interleukin-2 (IL-2), interleukin-10 (IL-10), c-reactive protein (CRP), RANTES, BDNF, VEGF, nerve growth factor (NGF), GDNF, Superoxide dismutase, catalase, glutathione peroxidase, total antioxidant capacity
Time frame
Baseline measurement only2
Inflammatory milieu comparison to controls
Blood serum levels of the following: IL-6, TNF, IL-1β, IL-2, IL-10, CRP, RANTES, BDNF, VEGF, NGF, GDNF, Superoxide dismutase, catalase, glutathione peroxidase, total antioxidant capacity
Time frame
Baseline measurement only3
Exercise dose and biomarkers
Change in blood serum levels of the following for the two different exercise conditions: IL-6, TNF, IL-1β, IL-2, IL-10, CRP, RANTES, BDNF, VEGF, NGF, GDNF, Superoxide dismutase, catalase, glutathione peroxidase, total antioxidant capacity, deglycase (DJ-1) protein, nonenzymatic antioxidants (Glutathione, Vitamin A, Vitamin C, Vitamin E).
Time frame
30 minutes prior to the exercise (pre measurement) and 30 minutes after completing the 30-minute aerobic exercise condition (post measurement) . Both conditions are separated by one week.4
Biomarkers in Parkinson Disease
Change in blood serum levels of the following for people with Parkinson's disease and older adults: IL-6, TNF, IL-1β, IL-2, IL-10, CRP, RANTES, BDNF, VEGF, NGF, GDNF, Superoxide dismutase, catalase, glutathione peroxidase, total antioxidant capacity, DJ-1 protein, nonenzymatic antioxidants (Glutathione, Vitamin A, Vitamin C, Vitamin E).
Time frame
30 minutes prior to the exercise (pre measurement) and 30 minutes after completing the 30-minute aerobic exercise condition (post measurement) . Both conditions are separated by one weekSponsors and contacts
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Source ClinicalTrials.gov