Influenza, HumanNCT03736759
Resistance Exercise to Improve Flu Vaccine for Older Adults
A study testing Exercise in people with Influenza, Human, run by University of Houston at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Exercise
- Type of treatment
- Vaccines, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2018to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resistance Exercise to Improve Vaccine Outcomes in 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.
Read the 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.
- Conditions
- Influenza, Human
- Being tested
- Exercise
- Keywords
- exercise, vaccine, older adults
- Medical subject headings
- Influenza, Human, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
10 sets of 5 repetitions of 80% of calculated one-repetition maximum weight of lateral side arm raise and biceps curls, alternating
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Exercise |
| vaccine only | No intervention | 20 min rest followed immediately by intramuscular injection of seasonal quadrivalent influenza vaccine in non-dominant arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline and 6 months
Secondary outcomes (2)
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).
Measured: 7 days
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: Measured monthly for six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start8 Oct 2018
- Primary completion30 Apr 2019
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Emily C Lavoy, University of Houston
- Investigators
- Emily C LaVoy, PhD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736759
- Sponsor's protocol ID
- STUDY00000542
- Other IDs
- R03AG052778
- Status last verified
- May 2022
- First submitted
- 7 Nov 2018
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
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.
PubMed 34456752
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Exercise to Improve Vaccine Outcomes in Older Adults
- ClinicalTrials.gov ID
- NCT03736759
- Acronym / sponsor ID
- STUDY00000542
- Conditions
- Influenza, Human
- Keywords
- exercise, vaccine, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise and vaccine in same arm | Experimental | Behavioral: Exercise20 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 |
| Exercise and vaccine in different arms | Active comparator | Behavioral: Exercise20 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 |
| vaccine only | No intervention | –20 min rest followed immediately by intramuscular injection of seasonal quadrivalent influenza vaccine in non-dominant arm |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise10 sets of 5 repetitions of 80% of calculated one-repetition maximum weight of lateral side arm raise and biceps curls, alternating | Behavioural | Exercise and vaccine in different arms, Exercise and vaccine in same arm |
Primary outcome
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
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
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
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
2 secondary outcomes
Muscle soreness
Time frame: 7 days
Influenza-like symptoms
Time frame: Measured monthly for six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 34456752Elzayat 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily C LaVoy, PhD principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Influenza, Human, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell mediated immunity change at 6 weeks post-vaccine (time frame: baseline and 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03736759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.