Exercise for Enhancing COVID-19 Immunization

Overseen By Kaitlyn Holden, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Iowa State University

Must not be taking: Immune suppressants

Disqualifiers: Pregnancy, Underweight, Immune disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a single session of light to moderate exercise, such as a brisk walk or jog, affects the immune response to the COVID-19 mRNA vaccine. Researchers aim to determine if exercising shortly after vaccination boosts the body's defenses, like antibodies and T cells, more than resting does. Participants will either exercise for 90 minutes after their shot or maintain their normal routine without exercise. This study suits individuals planning to receive the COVID-19 mRNA vaccine who already exercise regularly and can safely manage 90 minutes of light to moderate activity. As an unphased trial, it offers participants the chance to contribute to understanding how exercise might enhance vaccine effectiveness.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on medication that significantly impacts immune response, you may not be eligible to participate.

What prior data suggests that this exercise protocol is safe?

Research shows that most people can safely exercise soon after receiving a COVID-19 vaccine. Studies have found that light to moderate exercise, such as a brisk walk or jog for 90 minutes, poses no serious risks and can even increase antibody levels four weeks post-vaccination. This suggests exercise might enhance the body's response to the vaccine.

Additionally, recent COVID-19 vaccinations do not appear to affect how the body handles exercise, so getting a shot does not make exercising more dangerous. In fact, regular exercise might improve the immune system's response to the vaccine, especially in older individuals. Therefore, for those considering joining a trial involving exercise after vaccination, evidence suggests it is safe and could benefit the immune system. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using exercise to enhance COVID-19 immunization because it offers a simple, non-invasive way to potentially boost vaccine effectiveness. Unlike standard treatments that focus solely on the vaccine itself, this approach investigates how a 90-minute session of light to moderate exercise post-vaccination could enhance the body's immune response. This method is particularly appealing because exercise is a natural, accessible activity with numerous other health benefits, and if successful, it could lead to improved vaccine outcomes without the need for additional medications.

What evidence suggests that exercise post-immunization could enhance the immune response to the COVID-19 vaccine?

Research shows that exercising after receiving a COVID-19 vaccine might enhance the body's response. In this trial, one group of participants will engage in a supervised 90-minute light to moderate exercise session after their initial mRNA-based COVID-19 vaccine. One study found that such exercise increased the number of antibodies (proteins that fight viruses) in the blood four weeks after the shot. Another study found that exercising soon after vaccination might improve the vaccine's effectiveness. This suggests that light to moderate exercise could help the immune system respond more effectively to the COVID-19 vaccine. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 who are planning to get their initial or booster dose of a COVID-19 mRNA vaccine, exercise regularly, and can safely do 90 minutes of light to moderate exercise. It's not for pregnant individuals, those on immune-altering meds (for the initial vaccine part), or with conditions that make exercising unsafe.

Inclusion Criteria

I can give a small blood sample.

I plan to get my first mRNA COVID-19 vaccine.

Regularly participate in some form of exercise two or more times per week, including at least one session equal to or greater than 50 minutes exercise sessions or walk three or more times per week with at least one session equal to or greater than 50 minutes

Exclusion Criteria

I am on medication that affects my immune system or have an immune disorder.

I have no health issues preventing me from exercising safely or getting the mRNA COVID-19 vaccine.

I weigh less than 110 pounds.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Vaccination and Intervention

Participants receive the initial COVID-19 mRNA vaccine. Those in the exercise group perform a 90-minute light to moderate intensity exercise session within 30 minutes post-vaccination.

1 day

1 visit (in-person)

Short-term Follow-up

Participants are monitored for side effects and immune response. Blood samples are collected at 2 weeks and 1 month post-vaccination.

4 weeks

2 visits (in-person)

Long-term Follow-up

Participants are monitored for immune response with blood samples collected at 3, 6, and 12 months post-vaccination.

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview

The study tests if doing light to moderate exercise right after getting a COVID-19 mRNA vaccine affects the body's immune response. Participants will either walk or jog under supervision after vaccination and have blood samples taken over time to measure immunity changes.

How Is the Trial Designed?

Group I: Exercise post-immunization Experimental Treatment 1 Intervention

After the initial mRNA-based COVID-19 vaccine is received, a supervised 90 minute light to moderate exercise session will take place.

Group II: Daily routine as usual (control) Active Control 1 Intervention

After the initial mRNA-based COVID-19 vaccine is received, participants will be asked to go about their daily routine as usual, but avoid exercise for that day.

Who Is Running the Clinical Trial?

Iowa State University

Lead Sponsor

Trials

63

Recruited

145,000+

Published Research Related to This Trial

A single session of 90 minutes of light- to moderate-intensity exercise after vaccination significantly boosts the serum antibody response to vaccines for influenza and COVID-19, as shown in studies involving both human participants and a mouse model.

The exercise did not increase side effects following the COVID-19 vaccination, suggesting that incorporating physical activity post-immunization could enhance vaccine efficacy without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise after influenza or COVID-19 vaccination increases serum antibody without an increase in side effects. Hallam, J., Jones, T., Alley, J., et al.[2022]

Between 2012 and 2019, there was a significant decrease in physical activity counseling in women in southern Chile, with an average annual percentage change of -13.6%.

During the same period, obesity, hypertension, and elevated blood glucose levels significantly increased among the population, highlighting the need for improved physical activity counseling to prevent cardiometabolic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Trend in Physical Activity Counseling and Cardiometabolic Diseases in Maule, Chile: COVID-19 Pre-Pandemic Study between 2012 and 2019]. Vásquez-Gómez, J., Álvarez, C., Cigarroa, I., et al.[2023]

A systematic review of 27 studies suggests that sufficient physical activity is associated with a reduced risk of hospitalization and mortality from COVID-19, with a notable odds ratio of 0.54 for hospitalization and 0.61 for mortality.

Encouraging physical activity during the COVID-19 pandemic could be an effective health strategy to improve outcomes for individuals infected with the virus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between physical activity and risk of COVID-19 infection or clinical outcomes of the patients with COVID-19: A systematic review and meta-analysis. Halabchi, F., Mahdaviani, B., Tazesh, B., et al.[2023]

Regular physical activity is linked to improved immune function and a reduced risk of COVID-19 infection, similar to its effects on other respiratory infections.

Physical training and rehabilitation can enhance recovery and quality of life for COVID-19 patients, suggesting that exercise plays a crucial role in managing long-term symptoms and improving overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Is Medicine for Immune Function: Implication for COVID-19. Nieman, DC.[2023]

Physical activity significantly influences the immune response to vaccinations, including COVID-19 vaccines, by enhancing the activation of cytokines, antibodies, and immune cells.

The lack of consideration for participants' physical activity levels in clinical trials may limit the understanding of vaccine efficacy, especially in vulnerable populations like the elderly and obese.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why Physical Activity Should Be Considered in Clinical Trials for COVID-19 Vaccines: A Focus on Risk Groups. Bortolini, MJS., Petriz, B., Mineo, JR., et al.[2022]

Regular physical activity positively influences the immune response to COVID-19 vaccines, leading to higher antibody titers and improved levels of immune cells like CD4 and leukocytes, based on a review of 14 studies.

Factors such as age, gender, and the intensity of exercise play significant roles in the effectiveness of the vaccine response, with moderate-intensity long-term exercise being the most beneficial for enhancing immunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Physical Exercise Enhance the Immune Response after Vaccination? A Systematic Review for Clinical Indications of COVID-19 Vaccine. Barni, L., Carrasco-Vega, E., Olivieri, M., et al.[2023]

In a study involving mice, regular moderate exercise significantly improved the immune response to a vaccine (ovalbumin) by enhancing the production and proliferation of OVA-specific CD4(+) T cells across various lymphoid organs.

The findings suggest that combining moderate exercise with vaccination could potentially increase the effectiveness of vaccines in preventing or treating diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise enhances vaccine-induced antigen-specific T cell responses. Rogers, CJ., Zaharoff, DA., Hance, KW., et al.[2021]

Exercise significantly enhances the mobilization of functional SARS-CoV-2 specific T-cells in the blood, particularly after infection and vaccination, indicating a strong immune response.

The intensity of exercise influences the degree of T-cell mobilization, and vaccination further increases the number of T-cells recognizing the virus, suggesting that physical activity may play a role in improving immune responses to COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute exercise increases immune responses to SARS CoV-2 in a previously infected man. Baker, FL., Smith, KA., Zúñiga, TM., et al.[2023]

Enhancing oxygenation is a safe and effective intervention that significantly improves immunity and pulmonary functions in patients with COVID-19, as highlighted by a comprehensive review of clinical trials and literature.

A recommended exercise protocol for patients with COVID-19 includes mild to moderate cycling or walking at 60%-80% Vo2max for 20-60 minutes, 2-3 times per week, which can help enhance their immunity and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing oxygenation of patients with coronavirus disease 2019: Effects on immunity and other health-related conditions. Mohamed, A., Alawna, M.[2023]

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