NCT05854524 · University of Nevada, Las Vegas
Exercise Neuroprotection in Parkinson's Disease
(PDex)
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Aerobic exercise
The 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).
Primary outcome measures
Exercise and inflammatory milieu
Time frame: Baseline measurement only
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
Inflammatory milieu comparison to controls
Time frame: Baseline measurement only
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
Exercise dose and biomarkers
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.
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).
Biomarkers in Parkinson Disease
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
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. Inclusion criteria for controls:
- 30-85 years old
- No major medical diagnoses
- Able to participate in 30 minutes of continuous moderate aerobic exercise with 2-3 short breaks per self-report.
Exclusion criteria
- for both PD group and controls:
- 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.
Where
- Las Vegas, Nevada
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 3, 2024 · Source of record for eligibility and locations