Clinical trial NCT03736759: Resistance Exercise to Improve Flu Vaccine for Older Adults
Official title: Resistance Exercise to Improve Vaccine Outcomes in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza, Human
Keywords: exercise
vaccine
older adults
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-11-09
Enrollment: 29
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cell mediated immunity change at 6 weeks post-vaccine
timeFrame: baseline and 6 weeks
measure: Antibody titer change at 6 weeks post-vaccine
timeFrame: baseline and 6 weeks
measure: Cell mediated immunity change at 6 months post-vaccine
timeFrame: baseline and 6 months
measure: Antibody titer change at 6 months post-vaccine
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Muscle soreness
timeFrame: 7 days
measure: Influenza-like symptoms
timeFrame: Measured monthly for six months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: University of Houston
name: Emily C LaVoy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.