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

NCT02807623 | Completed Results

• 1 other identifier: 416446
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Immune System and Related Disorders

Outcome Measures

Primary Outcomes (1)

• Level of Pain

  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).

  baseline, 48-72 hours and at 21-28 days ( 3 points )

Secondary Outcomes (6)

• Serologic Response - A/California/7/2009

  Day 0 and between 21-28 days (2 points)

• Serologic Response - A/Hong Kong / 4801/2014

  Day 0 and between 21-28 days (2 points)

• Serologic Response - B/Phuket/3073/2013

  Day 0 and between 21-28 days (2 points)

• Serologic Response - B/Brisbane/60/2008

  Day 0 and between 21-28 days (2 points)

• Participants With Erythema

  baseline, 48- 72 hours, 21-28 days (3 points)

Other Outcomes (1)

• Lactate

  Immediately prior to Influenza vaccine and 3-8 minutes after Influenza vaccine was administered and after push-ups were completed.

Study Arms (3)

Ibuprofen

EXPERIMENTAL

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.

Drug: Ibuprofen

Placebo

PLACEBO COMPARATOR

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.

Drug: oral placebo

Compound Exercise of Push-ups

EXPERIMENTAL

Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.

Behavioral: Compound Exercise of Push-ups

Interventions

Ibuprofen DRUG

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.

Also known as: Motrin, Advil

Ibuprofen

Compound Exercise of Push-ups BEHAVIORAL

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.

Also known as: Push-ups

Compound Exercise of Push-ups

oral placebo DRUG

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.

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Womack Army Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (2)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

Location

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

Location

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MeSH Terms

Interventions

Ibuprofen; Sugars

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: Laurie Housel
• Organization: Defense Health Agency Immunization Healthcare Division South Atlantic Region Vaccine Safety hub

laurie.a.housel.civ@mail.mil

910-432-4015

Study Officials

• Laurie A. Housel, MSN,FNP

  Defense Health Agency Immunization Healthcare Branch

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 21, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 27, 2020
• Results First Posted: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)