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Completed

NCT Number: NCT03736759

Resistance Exercise to Improve Flu Vaccine for 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.

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Key information

Conditions

Influenza, Human Behavior Infections Motor Activity Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Houston

Houston, Texas, 77204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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

Primary outcomes

  1. Cell mediated immunity change at 6 weeks post-vaccine

    Time frame: 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

  2. Antibody titer change at 6 weeks post-vaccine

    Time frame: 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

  3. Cell mediated immunity change at 6 months post-vaccine

    Time frame: 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

  4. Antibody titer change at 6 months post-vaccine

    Time frame: 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

Secondary outcomes

  1. Muscle soreness

    Time frame: 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).

  2. Influenza-like symptoms

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Resistance Exercise to Improve Vaccine Outcomes in Older Adults

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Nov 9, 2018
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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