Resistance Exercise to Improve Flu Vaccine for Older Adults

Influenza, Human Clinical Trial

Official title:

Resistance Exercise to Improve Vaccine Outcomes in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736759
• Other study ID #: STUDY00000542
• Secondary ID: R03AG052778
• Status: Completed
• Phase: N/A
• Start date: October 8, 2018
• Est. completion date: April 1, 2021

Study information

• Verified date: May 2022
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 1, 2021
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Behavioral:
• Exercise
10 sets of 5 repetitions of 80% of calculated one-repetition maximum weight of lateral side arm raise and biceps curls, alternating

Locations

Country	Name	City	State
United States	University of Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Houston	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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