RECRUITING

Adjuvant Effect of Physical Exercise on Immune Response to COVID-19 Vaccination and Interactions With Stress

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effect of Health Behavioral Variables Including Single Session Exercise Post-immunization and Psychosocial Factors on Immune Response to the Initial COVID-19 mRNA Vaccine, and Underlying Mechanisms

Quick Facts

Study Start:2021-03-01
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05213000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to donate a small amount of blood,
  2. * Planning to receive an initial mRNA Severe Acute Respiratory Distress Syndrome Coronavirus 2 vaccine,
  3. * Between 18-64 years of age,
  4. * 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.
  5. * Can safely perform 90 minutes of light to moderate intensity exercise (walk, walk/jog, or jog) based on American College of Sports Medicine exercise participation guidelines
  1. * Currently pregnant
  2. * Weigh less than 110 pounds.
  3. * Presence of any conditions that could significantly impact the ability to exercise safely, or unable to receive the mRNA COVID-19 vaccine
  4. * Taking medication that significantly impact immune response or the presence of an immune disorder.

Contacts and Locations

Study Contact

Marian Kohut, PhD
CONTACT
5152948364
mkohut@iastate.edu
Kaitlyn Holden, PhD
CONTACT
5152948364
pettinkg@iastate.edu

Study Locations (Sites)

Iowa State University
Ames, Iowa, 50011
United States

Collaborators and Investigators

Sponsor: Iowa State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-01
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2021-03-01
Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Immunization