Resistance Exercise to Improve Flu Vaccine for Older Adults

NCT03736759 | Completed DMC

• 2 other identifiers: STUDY00000542R03AG052778
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza, Human

Keywords

exercise; vaccine; older adults

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Muscle soreness

  7 days

• Influenza-like symptoms

  Measured monthly for six months

Study Arms (3)

Exercise and vaccine in same arm

EXPERIMENTAL

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

Exercise and vaccine in different arms

ACTIVE COMPARATOR

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

vaccine only

NO INTERVENTION

20 min rest followed immediately by intramuscular injection of seasonal quadrivalent influenza vaccine in non-dominant arm

Interventions

Exercise BEHAVIORAL

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

Exercise and vaccine in different arms; Exercise and vaccine in same arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Houston: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

Location

Related Publications (1)

• 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.

  PMID: 34456752 DERIVED

MeSH Terms

Conditions

Influenza, Human; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Emily C LaVoy, PhD

  University of Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 9, 2018
• Study Start: October 8, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 1, 2021
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.

Locations

US (1)