Resistance Exercise to Improve Flu Vaccine for Older Adults
- Conditions
- Influenza, Human
- Interventions
- Behavioral: Exercise
- Registration Number
- NCT03736759
- Lead Sponsor
- University of Houston
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise and vaccine in same arm Exercise 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 Exercise and vaccine in different arms Exercise 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
- Primary Outcome Measures
Name Time Method Cell mediated immunity change at 6 weeks post-vaccine baseline and 6 weeks 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
Antibody titer change at 6 weeks post-vaccine baseline and 6 weeks The change in influenza-specific antibody titers in serum measured by hemagglutination inhibition assay will be calculated from baseline at 6 weeks post-vaccine
Antibody titer change at 6 months post-vaccine baseline and 6 months The change in influenza-specific antibody titers in serum measured by hemagglutination inhibition assay will be calculated from baseline at 6 months post-vaccine
Cell mediated immunity change at 6 months post-vaccine baseline and 6 months 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
- Secondary Outcome Measures
Name Time Method Influenza-like symptoms Measured monthly for six months 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)
Muscle soreness 7 days 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).
Trial Locations
- Locations (1)
University of Houston
🇺🇸Houston, Texas, United States