Resistance Exercise to Improve Flu Vaccine for Older Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Resistance Exercise to Improve Vaccine Outcomes in Older Adults

Conditions
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Influenza, Human

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, vaccine, older adults