Resistance Exercise to Improve Flu Vaccine for Older Adults
16. maj 2022 opdateret af: Emily C Lavoy, University of Houston
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
29
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77204
- University of Houston
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Exercise and vaccine in same arm
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
|
10 sets of 5 repetitions of 80% of calculated one-repetition maximum weight of lateral side arm raise and biceps curls, alternating
|
|
Aktiv komparator: Exercise and vaccine in different arms
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
|
10 sets of 5 repetitions of 80% of calculated one-repetition maximum weight of lateral side arm raise and biceps curls, alternating
|
|
Ingen indgriben: vaccine only
20 min rest followed immediately by intramuscular injection of seasonal quadrivalent influenza vaccine in non-dominant arm
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cell mediated immunity change at 6 weeks post-vaccine
Tidsramme: 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
|
baseline and 6 weeks
|
|
Antibody titer change at 6 weeks post-vaccine
Tidsramme: 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
|
baseline and 6 weeks
|
|
Cell mediated immunity change at 6 months post-vaccine
Tidsramme: 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
|
baseline and 6 months
|
|
Antibody titer change at 6 months post-vaccine
Tidsramme: 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
|
baseline and 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Muscle soreness
Tidsramme: 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).
|
7 days
|
|
Influenza-like symptoms
Tidsramme: 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)
|
Measured monthly for six months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Emily C LaVoy, PhD, University of Houston
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
8. oktober 2018
Primær færdiggørelse (Faktiske)
30. april 2019
Studieafslutning (Faktiske)
1. april 2021
Datoer for studieregistrering
Først indsendt
7. november 2018
Først indsendt, der opfyldte QC-kriterier
7. november 2018
Først opslået (Faktiske)
9. november 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. maj 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. maj 2022
Sidst verificeret
1. maj 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00000542
- R03AG052778 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD-delingstidsramme
Data will be available within 6 months of study completion.
IPD-delingsadgangskriterier
Data access requests will be reviewed by an external independent review panel.
Requestors will be required to sign a Data Access Agreement.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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Ingen
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