Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation
NCT ID: NCT02807623
Last Updated: 2020-11-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2016-09-30
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Ibuprofen
Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.
Ibuprofen
The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
Placebo
Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.
oral placebo
The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
Compound Exercise of Push-ups
Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.
Compound Exercise of Push-ups
The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt.
Interventions
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Ibuprofen
The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
Compound Exercise of Push-ups
The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt.
oral placebo
The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Be Active Duty Service Members.
2. at least 18 years of age or older.
3. Be requiring and eligible for inactivated influenza vaccine receipt.
4. Be willing and able to complete the study protocol requirements.
5. Have a current Flu Screening Form with medical clearance to receive the influenza vaccination.
Exclusion Criteria
1. Have already received influenza vaccine for the current season.
2. Have received any type of vaccine in the previous 72 hours.
3. Be on a medical profile resulting in current profile exemption from Physical Training of Upper 2 or Upper 3. (Upper extremity injury or illness)
4. Have preexisting symptoms of injury or infection or other local symptoms that would interfere with site assessment.
5. Be pregnant.
6. Have a history of allergy, intolerance, stomach bleeding or other medical exclusion for ibuprofen.
7. Have a history of stroke or coronary artery disease, such as uncontrolled high blood pressure or abnormal heart beat.
8. 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.
9. 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)
10. Currently participating in any other study
\-
18 Years
ALL
Yes
Sponsors
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United States Department of Defense
FED
Womack Army Medical Center
FED
Responsible Party
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Principal Investigators
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Laurie A. Housel, MSN,FNP
Role: PRINCIPAL_INVESTIGATOR
Defense Health Agency Immunization Healthcare Branch
Locations
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Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Womack Army Medical Center
Fort Bragg, North Carolina, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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416446
Identifier Type: -
Identifier Source: org_study_id