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NCT05213000 · ClinicalTrials.gov registry record · NA
Adjuvant Effect of Physical Exercise on Immune Response to COVID-19 Vaccination and Interactions With Stress
A NA study of Immunization, sponsored by Iowa State University.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT05213000: Recruiting NA study of Immunization, sponsored by Iowa State University.
NCT05213000 is a NA study of Immunization that is actively recruiting participants, run by Iowa State University. The registered enrollment target is 80 participants, below the 16,035-participant average among 5 other Immunization trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05213000, a NA study of Immunization, is actively recruiting participants, sponsored by Iowa State University.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
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 w
Primary Outcome
Change in the total serum anti-receptor binding domain IgG antibody and neutralizing antibody to Severe Acute Respiratory Syndrome Coronavirus 2
Conditions Studied
Interventions
- BEHAVIORAL Exercise
Study Locations (1)
Iowa
- Iowa State University - Ames
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2026-09-30 |
| Phase | NA |
What NCT05213000 shows while recruiting
NCT05213000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 16,035-participant average among 5 other Immunization trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Immunization appearing as the primary indexed condition, and to 1 intervention - of which Exercise is the first listed.
NCT05213000 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT05213000 about?
NCT05213000 is a clinical study titled "Adjuvant Effect of Physical Exercise on Immune Response to COVID-19 Vaccination and Interactions With Stress". 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 mechanis...
What is the current status of trial NCT05213000?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2021-03-01. Estimated completion is 2026-09-30.
What conditions does trial NCT05213000 study?
This clinical trial studies the following conditions: Immunization.
What interventions are being tested in trial NCT05213000?
The interventions under investigation include: Exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT05213000?
This trial is sponsored by Iowa State University, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05213000 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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