ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611001119987

Ethics application status

Approved

Date submitted

26/10/2011

Date registered

26/10/2011

Date last updated

12/07/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Boosting influenza vaccine responses in the elderly using a brief bout of exercise

Scientific title

Antibody responses to influenza vaccination in the elderly: effects of a brief bout of weight-lifting exercise versus quiet rest immediately before vaccination

Secondary ID [1]

3344/2011 The Clive and Vera Ramaciotti Foundations

Universal Trial Number (UTN)

U1111-1125-4605

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Advanced age

Influenza vaccine responses

Condition category

Condition code

Inflammatory and Immune System

Normal development and function of the immune system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A brief (30 minute) moderate intensity weight-lifting exercise task, performed only once immediately prior to receipt of the vaccine. The task includes 4 exercises using weights machines (2 lower body, 2 upper body), which are performed at 60% of previously determined single-repetition maximal strength. All exercise is supervised in the STRONG medicine centre at Balmain hospital, supervised by an exercise physiologist.

Intervention code [1]

Treatment: Other

Intervention code [2]

Prevention

Comparator / control treatment

Quiet rest (30 minutes), with participants seated in a chair. Vaccination will be administered after this resting period.

Control group

Active

Outcomes

Primary outcome [1]

Response to vaccination, measured by antibody titres specific to influenza strains contained in the vaccine

Timepoint [1]

Baseline (prior to vaccination), 1 month and 6 months post vaccination

Secondary outcome [1]

Response to vaccination measure by T-cell response to antigen (isolated PBMCs interferon-gamma response to stimulation with vaccine).

Timepoint [1]

Baseline, 1 month, 6 months

Secondary outcome [2]

Self-reported incidence of influenza-like illness

Timepoint [2]

Throughout study period (6 months immediatly after reciept of vaccine)

Eligibility

Key inclusion criteria

Aged 65 years or older.

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

History of vaccine related allergies or side-effects; allergy to any constituent of the vaccine (including eggs and chicken); current immune disorder (including rheumatoid arthritis and asthma) or acute infection; current steroid or anticoagulant medication, any joint injury or pain which restricts completion of the exercise task, or recent history (6 months prior) of strength training

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation will involve contacting the holder of the allocation schedule (CI) who at central administration site.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Compterised sequence generation

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Participant recruitment difficulties

Date of first participant enrolment

Anticipated

1/03/2012

Actual

1/03/2012

Date of last participant enrolment

Anticipated

Actual

1/08/2012

Date of last data collection

Anticipated

Actual

1/03/2013

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2041

Recruitment postcode(s) [2]

2039

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

The Clive and Vera Ramaciotti Foundations

Address [1]

Angel Place,
Level 12, 123 Pitt Street,
Sydney, NSW 2001

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

The University of Sydney
NSW 2006

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Balmain Hospital

Address [1]

27 Booth street
Balmain. 2041.
NSW

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

SLHD Human Research Ethics Committee (CRGH)

Ethics committee address [1]

c/- Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/11/2011

Approval date [1]

20/01/2012

Ethics approval number [1]

Summary

Brief summary

Acute exercise mildly activates the immune system; we have found that a short bout of exercise immediately before receiving a vaccine helps your immune system to respond better and give you more protection from disease. This has been seen in young healthy adults; now we want to test this unusual idea in people who could benefit most: the elderly. Those aged over 65 years are at greatest risk for influenza illness, and have been found to show weakest and worst maintained responses to vaccination. As such, a simple, safe, cheap and cost-effective intervention to enhance the vaccine response in the elderly is highly relevant and offers a unique, promising possibility that should be explored to better protect the elderly from ‘flu.

Trial website

Trial related presentations / publications

Edwards KM, Pascoe AR, Fiatarone-Singh MA, Sing NA, Kok, J, Booy R. A randomised controlled trial of resistance exercise prior to administration of influenza vaccination in older adults. Brain, Behavior and Immunity. 2015; e24-e25.

Public notes

Contacts

Principal investigator

Name

Dr Kate Edwards

Address

University of Sydney,
C42-Cumberland Campus
Lidcombe, 2141
NSW

Country

Australia

Phone

+61290367396

Fax

kate.edwards@sydney.edu.au

Contact person for public queries

Name

Kate Edwards

Address

University of Sydney
C42-Cumberland Campus
K207 Exercise and Sport Science
Lidcombe, NSW 2141

Country

Australia

Phone

+61290367396

Fax

kate.edwards@sydney.edu.au

Contact person for scientific queries

Name

Kate Edwards

Address

University of Sydney
C42-Cumberland Campus
K207 Exercise and Sport Science
Lidcombe, NSW 2141

Country

Australia

Phone

+61290367396

Fax

kate.edwards@sydney.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Acute exercise decreases vaccine reactions following influenza vaccination among older adults.	2020	https://dx.doi.org/10.1016/j.bbih.2019.100009

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically