Resistance Exercise to Improve Flu Vaccine for Older Adults

Resistance Exercise to Improve Vaccine Outcomes in Older Adults

This study evaluates whether resistance exercise will improve immune responses to the seasonal influenza vaccine in older adults. One third of the participants will perform exercise in the arm that receives the vaccine, one third of the participants will perform the same exercise in the arm that does not receive the vaccine, and one third will only receive the vaccine.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Behavioral: Exercise

Detailed Description

Resistance exercise, particularly novel eccentric exercise, recruits immune cells to the targeted muscle. The exercises selected here targets the deltoid and biceps brachii muscles-those same muscles that the flu vaccine is delivered to during typical vaccination.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • University of Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• non-frail older adult (≥65 years old) of any sex and race/ethnicity
• non-smokers (>10 yrs)
• meets American College of Sports Medicine criteria for participation in exercise
• US resident

Exclusion Criteria:

• underlying medical problems that contraindicate supervised resistance exercise
• past or present history of autoimmune disease, HIV, hepatitis, stroke, or cardiovascular disease
• current debilitating arthritis of the shoulder
• central or peripheral nervous disorders
• bedridden in the past three months
• history of vaccine-related allergies, or severe egg allergy;
• physician-confirmed influenza infection in the prior year
• regular user of corticosteroids
• functional or cognitive impairment that would limit exercise performance or prohibit informed consent
• blood pressure greater than 160/90
• participation in resistance arm exercises in the prior 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise and vaccine in same arm; 20 min eccentric resistance exercise of deltoid and biceps brachii in non-dominant arm, followed immediately by intramuscular injection of seasonal quadrivalent influenza vaccine in non-dominant arm	Behavioral: Exercise; 10 sets of 5 repetitions of 80% of calculated one-repetition maximum weight of lateral side arm raise and biceps curls, alternating
Active Comparator: Exercise and vaccine in different arms; 20 min eccentric resistance exercise of deltoid and biceps brachii in dominant arm, followed immediately by intramuscular injection of seasonal quadrivalent influenza vaccine in non-dominant arm	Behavioral: Exercise; 10 sets of 5 repetitions of 80% of calculated one-repetition maximum weight of lateral side arm raise and biceps curls, alternating
No Intervention: vaccine only; 20 min rest followed immediately by intramuscular injection of seasonal quadrivalent influenza vaccine in non-dominant arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cell mediated immunity change at 6 weeks post-vaccine	The change in the peripheral blood mononuclear cell response to overnight ex vivo culture with the seasonal quadrivalent vaccine detected via Interferon-gamma ELISPOT will be calculated from baseline at 6 weeks post-vaccine	baseline and 6 weeks
Antibody titer change at 6 weeks post-vaccine	The change in influenza-specific antibody titers in serum measured by hemagglutination inhibition assay will be calculated from baseline at 6 weeks post-vaccine	baseline and 6 weeks
Cell mediated immunity change at 6 months post-vaccine	The change in the peripheral blood mononuclear cell response to overnight ex vivo culture with the seasonal quadrivalent vaccine detected via Interferon-gamma ELISPOT will be calculated from baseline at 6 months post-vaccine	baseline and 6 months
Antibody titer change at 6 months post-vaccine	The change in influenza-specific antibody titers in serum measured by hemagglutination inhibition assay will be calculated from baseline at 6 months post-vaccine	baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle soreness	Self-reported pain in upper arm shoulder/ region of both arms collected once daily for 7 days after vaccination. Item will be scored 0-10 (0= no pain; 10= worst possible pain).	7 days
Influenza-like symptoms	Self-report symptoms of influenza infection, guided by an influenza self-screening questionnaire( modified from University of California Davis Student Health and Counseling Service influenza self-screening questionnaire)	Measured monthly for six months

Collaborators and Investigators

• Sponsor: University of Houston
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Emily C LaVoy, PhD, University of Houston

Publications and helpful links

General Publications

• Elzayat MT, Markofski MM, Simpson RJ, Laughlin M, LaVoy EC. No Effect of Acute Eccentric Resistance Exercise on Immune Responses to Influenza Vaccination in Older Adults: A Randomized Control Trial. Front Physiol. 2021 Aug 12;12:713183. doi: 10.3389/fphys.2021.713183. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: November 7, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: exercise; older adults; vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: STUDY00000542; R03AG052778 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No