Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation

Not Applicable

Completed

Interventions: Drug: oral placebo
Behavioral: Compound Exercise of Push-ups
Drug: Ibuprofen

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 oral placebo to decrease local injection site inflammation symptoms of delayed pain, erythema, and edema and any impact on serologic antibody immune response after influenza vaccine receipt.

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 local injection site inflammation symptoms of delayed pain, erythema, and edema and any impact on serologic antibody immune response after influenza vaccine receipt. A healthy military cohort will be randomly assigned to either perform push-ups consistent with their army physical fitness score, or to take a blinded oral medication which will be an NSAID (ibuprofen) or an oral placebo. The study will require three visits for assessment: on the day of vaccine receipt, 48-72 hours later and 21 -28 days later. The assessment visits will include injection site inspection, an injection site photograph, completion of symptom diaries and a validated pain scale and a laboratory blood specimen at the first and third visit to measure antibody level changes. The exercise participants will also be required to provide 1-2 fingerstick blood samples to evaluate for lactate, which is a byproduct of anaerobic exercise to measure if level of exercise effort achieved anaerobic metabolism. The study will evaluate if either of the interventions impacted perceived delayed pain, physical signs of inflammation or antibody response as measured by serology.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Placebo	oral 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.
Compound Exercise of Push-ups	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.
Ibuprofen	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.

Primary Outcome Measures

Name	Time	Method
Level of Pain	baseline, 48-72 hours and at 21-28 days ( 3 points )	Level of Pain will be measured by validated pain scale, using a scale of 0 ( best, no pain) to 10 (worst, as bad as imaginable, completely interferes).

Secondary Outcome Measures

Name	Time	Method
Serologic Response - A/Hong Kong / 4801/2014	Day 0 and between 21-28 days (2 points)	Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response
Serologic Response - B/Brisbane/60/2008	Day 0 and between 21-28 days (2 points)	Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response
Participants With Edema	baseline, 48-72 hours, and 21- 28 days (3 points)	Swelling at vaccination site
Serologic Response - A/California/7/2009	Day 0 and between 21-28 days (2 points)	Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response
Participants With Erythema	baseline, 48- 72 hours, 21-28 days (3 points)	Reddening of the skin at vaccination site reported as the total number of participants with erythema over the duration of the study.
Serologic Response - B/Phuket/3073/2013	Day 0 and between 21-28 days (2 points)	Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response

Locations (2): Walter Reed National Military Medical Center
🇺🇸
Bethesda, Maryland, United States
Womack Army Medical Center
🇺🇸
Fort Bragg, North Carolina, United States