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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] 273275 0
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 279039 0
Influenza vaccine responses 279041 0
Condition category
Condition code
Inflammatory and Immune System 279226 279226 0 0
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] 269618 0
Treatment: Other
Intervention code [2] 283620 0
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] 279857 0
Response to vaccination, measured by antibody titres specific to influenza strains contained in the vaccine
Timepoint [1] 279857 0
Baseline (prior to vaccination), 1 month and 6 months post vaccination
Secondary outcome [1] 294590 0
Response to vaccination measure by T-cell response to antigen (isolated PBMCs interferon-gamma response to stimulation with vaccine).
Timepoint [1] 294590 0
Baseline, 1 month, 6 months
Secondary outcome [2] 294591 0
Self-reported incidence of influenza-like illness
Timepoint [2] 294591 0
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 4658 0
2041
Recruitment postcode(s) [2] 4659 0
2039

Funding & Sponsors
Funding source category [1] 284107 0
Charities/Societies/Foundations
Name [1] 284107 0
The Clive and Vera Ramaciotti Foundations
Address [1] 284107 0
Angel Place,
Level 12, 123 Pitt Street,
Sydney, NSW 2001
Country [1] 284107 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 269069 0
Hospital
Name [1] 269069 0
Balmain Hospital
Address [1] 269069 0
27 Booth street
Balmain. 2041.
NSW
Country [1] 269069 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272055 0
SLHD Human Research Ethics Committee (CRGH)
Ethics committee address [1] 272055 0
c/- Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 272055 0
Australia
Date submitted for ethics approval [1] 272055 0
14/11/2011
Approval date [1] 272055 0
20/01/2012
Ethics approval number [1] 272055 0

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 33314 0
Dr Kate Edwards
Address 33314 0
University of Sydney,
C42-Cumberland Campus
Lidcombe, 2141
NSW
Country 33314 0
Australia
Phone 33314 0
+61290367396
Fax 33314 0
Email 33314 0
kate.edwards@sydney.edu.au
Contact person for public queries
Name 16561 0
Dr Kate Edwards
Address 16561 0
University of Sydney
C42-Cumberland Campus
K207 Exercise and Sport Science
Lidcombe, NSW 2141
Country 16561 0
Australia
Phone 16561 0
+61290367396
Fax 16561 0
Email 16561 0
kate.edwards@sydney.edu.au
Contact person for scientific queries
Name 7489 0
Dr Kate Edwards
Address 7489 0
University of Sydney
C42-Cumberland Campus
K207 Exercise and Sport Science
Lidcombe, NSW 2141
Country 7489 0
Australia
Phone 7489 0
+61290367396
Fax 7489 0
Email 7489 0
kate.edwards@sydney.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary