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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the extent to which a single session of light to moderate intensity exercise performed within 30 minutes after receiving either the initial dose of COVID-19 mRNA vaccine may modify the immune response to vaccination, and identify potential underlying mechanisms using gene expression and metabolite analysis. A secondary goal is to establish whether psychosocial factors are associated with immune response to vaccination. Participants will be randomized to either a 90-minute light to moderate intensity exercise session or daily routine as usual (no exercise) after receiving their initial COVID-19 mRNA vaccine. If assigned to exercise, the exercise will begin within 30 minutes after receiving the vaccine and will consist of a brisk walk and/or jog supervised by study personnel. Blood will be collected from participants prior the initial dose, two weeks after the initial dose, one week after the second dose if the individual receive the two-dose vaccine regiment or one month after the initial dose if the individual receives a one-dose vaccine regimen, and three, six, and 12 months following the initial dose. . Side effects will be measured for three days post-vaccination. Antibody and cell-mediated immune response to the vaccine will be measured in blood samples. Gene expression profiles will be analyzed by single cell RNA sequencing. Serum metabolites will be assessed to align with immune measures. Participants will be asked to complete surveys to measure physical activity history, psychosocial stress, resilience, and depression. The hypotheses of this study are: 1) a single session of exercise which take place shortly after receiving either the initial dose or the booster dose of COVID-19 will increase antibody and T cell response to the vaccine and will be associated with differentially expressed genes and an altered metabolite profile, and 2) higher levels of reported stress, and lower levels of resilience will be associated with a reduced antibody and T cell response to the vaccine.

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 data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for enhancing COVID-19 immunization?

Research suggests that regular exercise can boost the immune system, which may help improve the effectiveness of vaccines, including those for COVID-19. Studies have shown that physical activity is linked to a lower risk of infections and can enhance the body's response to vaccines, similar to findings with other respiratory infections like influenza. ^{1 2 3 4 5}

Is exercise safe for humans when used to enhance COVID-19 immunization?

Research shows that exercise, such as light to moderate-intensity activities like walking or cycling, can increase the immune response to vaccines without increasing side effects. Regular physical activity is generally safe and can improve immune function, which may help in fighting infections like COVID-19. ^{1 2 3 6 7}

How does exercise as a treatment enhance COVID-19 immunization compared to other treatments?

Exercise as a treatment is unique because it acts as a natural 'adjuvant' (a substance that enhances the body's immune response to an antigen) by increasing the body's antibody response to vaccines without increasing side effects. Unlike traditional drug treatments, exercise involves physical activity, such as light to moderate-intensity workouts, which can boost the immune system and improve vaccine efficacy. ^{1 3 6 8 9}

Eligibility Criteria

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.

I am between 18 and 64 years old.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Chile 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]. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Does Physical Exercise Enhance the Immune Response after Vaccination? A Systematic Review for Clinical Indications of COVID-19 Vaccine. [2023]

4. Italy 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise after influenza or COVID-19 vaccination increases serum antibody without an increase in side effects. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Why Physical Activity Should Be Considered in Clinical Trials for COVID-19 Vaccines: A Focus on Risk Groups. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Acute exercise increases immune responses to SARS CoV-2 in a previously infected man. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise enhances vaccine-induced antigen-specific T cell responses. [2021]