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Resistance Exercise to Improve Flu Vaccine for Older Adults

Primary Purpose

Influenza, Human

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Influenza, Human focused on measuring exercise, vaccine, older adults

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Exercise and vaccine in same arm

Exercise and vaccine in different arms

vaccine only

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

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).
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)

Full Information

First Posted
November 7, 2018
Last Updated
May 16, 2022
Sponsor
University of Houston
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03736759
Brief Title
Resistance Exercise to Improve Flu Vaccine for Older Adults
Official Title
Resistance Exercise to Improve Vaccine Outcomes in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 8, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human
Keywords
exercise, vaccine, older adults

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise and vaccine in same arm
Arm Type
Experimental
Arm Description
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
Arm Title
Exercise and vaccine in different arms
Arm Type
Active Comparator
Arm Description
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
Arm Title
vaccine only
Arm Type
No Intervention
Arm Description
20 min rest followed immediately by intramuscular injection of seasonal quadrivalent influenza vaccine in non-dominant arm
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
10 sets of 5 repetitions of 80% of calculated one-repetition maximum weight of lateral side arm raise and biceps curls, alternating
Primary Outcome Measure Information:
Title
Cell mediated immunity change at 6 weeks post-vaccine
Description
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
Time Frame
baseline and 6 weeks
Title
Antibody titer change at 6 weeks post-vaccine
Description
The change in influenza-specific antibody titers in serum measured by hemagglutination inhibition assay will be calculated from baseline at 6 weeks post-vaccine
Time Frame
baseline and 6 weeks
Title
Cell mediated immunity change at 6 months post-vaccine
Description
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
Time Frame
baseline and 6 months
Title
Antibody titer change at 6 months post-vaccine
Description
The change in influenza-specific antibody titers in serum measured by hemagglutination inhibition assay will be calculated from baseline at 6 months post-vaccine
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
Muscle soreness
Description
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).
Time Frame
7 days
Title
Influenza-like symptoms
Description
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)
Time Frame
Measured monthly for six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily C LaVoy, PhD
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data will be available within 6 months of study completion.
IPD Sharing Access Criteria
Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.
Citations:
PubMed Identifier
34456752
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.
Results Reference
derived

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Resistance Exercise to Improve Flu Vaccine for Older Adults

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