Status:
COMPLETED
Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation
Lead Sponsor:
Womack Army Medical Center
Collaborating Sponsors:
United States Department of Defense
Conditions:
Immune System and Related Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this clinical investigation is to evaluate the efficacy and immunologic effects of a non-pharmacological exercise intervention (push-ups) compared to an oral NSAID (ibuprofen) and an or...
Detailed Description
The study will evaluate the efficacy and immunologic effects of a non-pharmacological exercise intervention (push-ups) compared to an oral NSAID (ibuprofen) and a blinded oral placebo to decrease loca...
Eligibility Criteria
Inclusion
- Must:
- Be Active Duty Service Members.
- at least 18 years of age or older.
- Be requiring and eligible for inactivated influenza vaccine receipt.
- Be willing and able to complete the study protocol requirements.
- Have a current Flu Screening Form with medical clearance to receive the influenza vaccination.
Exclusion
- Must Not:
- Have already received influenza vaccine for the current season.
- Have received any type of vaccine in the previous 72 hours.
- Be on a medical profile resulting in current profile exemption from Physical Training of Upper 2 or Upper 3. (Upper extremity injury or illness)
- Have preexisting symptoms of injury or infection or other local symptoms that would interfere with site assessment.
- Be pregnant.
- Have a history of allergy, intolerance, stomach bleeding or other medical exclusion for ibuprofen.
- Have a history of stroke or coronary artery disease, such as uncontrolled high blood pressure or abnormal heart beat.
- Has taken any topical or oral pain medications from the following medication classes in the past 24 hours prior to the start of the study: oral acetaminophen, opioids, tramadol, nonsteroidal anti-inflammatory drug (NSAID) or acetylsalicylic acid (ASA) or topical pain relievers or counterirritants of menthol, methyl salicylate, camphor menthols, and capsaicins.
- Have any chronic or acute illness or treatment causing immunological suppression such as current oral steroid therapy, malignancy or chemotherapy or lung disease. (not including controlled asthma)
- Currently participating in any other study
- \-
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT02807623
Start Date
September 1 2016
End Date
December 1 2018
Last Update
November 27 2020
Active Locations (2)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
2
Womack Army Medical Center
Fort Bragg, North Carolina, United States, 28310