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Trial - NCT05213000


Column Value
Trial registration number NCT05213000
Full text link
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Marian Kohut, PhD

Contact
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

mkohut@iastate.edu

Registration date
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

2022-01-28

Recruitment status
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : March 3, 2023, noon
Source : ClinicalTrials.gov

inclusion criteria: able to donate a small amount of blood, planning to receive either the initial covid vaccine immunization series or the booster dose (3rd dose) of an mrna-based severe acute respiratory distress syndrome coronavirus 2 vaccine, between 18-70 years of age, regularly participate in some form of exercise, including longer duration exercise sessions 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

Exclusion criteria
Last imported at : March 3, 2023, noon
Source : ClinicalTrials.gov

currently pregnant presence of any conditions that could significantly impact the ability to exercise safely, or unable to receive the booster vaccine taking medication that significantly impact immune response or the presence of an immune disorder (applies only to initial covid immunization portion of the project)

Number of arms
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Iowa State University

Inclusion age min
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

70

Countries
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : March 3, 2023, noon
Source : ClinicalTrials.gov

200

primary outcome
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Change in Gene expression profile;Change in Metabolites;Change in Serum antibody;Change in T cell response

Notes
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2143, "treatment_name": "Exercise+mrna vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]