Actively Recruiting
Effect of Single Session Exercise and Psychosocial Factors on Immune Response to Initial COVID-19 mRNA Vaccine
Led by Iowa State University · Updated on 2023-08-24
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess how a single session of light to moderate exercise performed within 30 minutes after receiving the initial COVID-19 mRNA vaccine dose may influence the immune response to vaccination. It also explores whether psychosocial factors like stress, resilience, or depression affect the vaccine's immune response. Participants will be adults aged 18 to 64 who regularly exercise and plan to receive their initial mRNA COVID-19 vaccine dose. Participants are randomly assigned to either a supervised 90-minute exercise session or to continue their usual daily routine without exercise after vaccination. The exercise involves brisk walking or jogging, adjusted for each participant's fitness level and monitored by heart rate and perceived exertion. Those in the control group are asked to avoid exercise on vaccination day. Blood samples and psychosocial surveys will be collected before vaccination and at multiple points up to 12 months afterward to study antibody levels, T cell responses, gene expression, and metabolites. During the study, participants will complete surveys about physical activity and psychosocial health, record side effects for three days post-vaccination, and provide blood samples at specified intervals: before vaccination, two weeks after, one week after the second dose or one month after a single dose, and at three, six, and twelve months. Researchers will analyze immune responses, gene activity, and metabolites, comparing exercise and control groups. Side effects and psychosocial factors will also be monitored to understand their relationship with immune responses over a year-long follow-up.
CONDITIONS
Brief Title
Adjuvant Effect of Physical Exercise on Immune Response to COVID-19 Vaccination and Interactions With Stress
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to donate a small amount of blood
- Planning to receive an initial mRNA COVID-19 vaccine
- Between 18 and 64 years old
- Regularly exercise at least two times per week, including sessions of 50 minutes or longer, or walk three or more times per week with at least one session of 50 minutes or longer
- Can safely perform 90 minutes of light to moderate exercise such as walking or jogging based on exercise guidelines
You will not qualify if you...
- Currently pregnant
- Weigh less than 110 pounds
- Have any condition that would significantly affect the ability to exercise safely or prevent receiving the mRNA COVID-19 vaccine
- Taking medication that significantly affects immune response or have an immune disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for blood collection and psychosocial surveys before vaccination
Duration - 1 day
Participants receive the initial COVID-19 mRNA vaccine. Those in the exercise group complete a supervised 90-minute light to moderate exercise session within 30 minutes after vaccination. Those in the control group continue their daily routine without exercise on vaccination day. Participants record vaccine side effects for 72 hours after vaccination.
1 vaccination and exercise or control condition visit, plus side effect reporting for 3 days
Duration - Up to 12 months
Participants return for blood collection at multiple time points following vaccination to assess immune response and gene expression changes.
5 visits at 7 days, approximately 1 month, 3 months, 6 months, and 12 months after vaccination
Trial Site Locations
Total: 1 location
1
Iowa State University
Ames, Iowa, United States, 50011
Actively Recruiting
Research Team
M
Marian Kohut, PhD
K
Kaitlyn Holden, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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