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Trial registered on ANZCTR

Registration number

ACTRN12614001185651

Ethics application status

Approved

Date submitted

31/10/2014

Date registered

11/11/2014

Date last updated

23/11/2018

Date data sharing statement initially provided

23/11/2018

Date results provided

23/11/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Effects of a simple exercise intervention on adverse reactions and immune response to Human Papillomavirus (HPV) vaccination

Scientific title

Assessing the effect of 15 mins upper body exercise (using therabands) on the adverse event reporting after HPV vaccination in 11-13 year old boys and girls, compared to usual care.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1163-5625

Trial acronym

HEAVE (Hpv vaccination, Exercise and Adverse eVEnts)

Linked study record

Health condition

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

HPV vaccination and related local adverse events

Prevention of HPV infection

Condition category

Condition code

Infection

Sexually transmitted infections

Alternative and Complementary Medicine

Other alternative and complementary medicine

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention is a 15 minute exercise task using rubber therabands, administered in small groups with instruction from an exercise scientist. Participants will exercise for 30 seconds followed by 30 seconds rest, rotating between 3 techniques (bicep curls, lateral raises and chest press), and completing 5 x30 seconds of each exercise by the end of the task. Shortly after the completion of the exercise task the vaccine will be administered. The exercise task will be completed before each of the 3 doses of vaccine (baseline, 2 months and 6 months)

Intervention code [1]

Behaviour

Intervention code [2]

Prevention

Comparator / control treatment

Usual care - resting quietly prior to vaccination.

Both groups will rest quietly for 15 minutes after the vaccination according to usual care.

Control group

Active

Outcomes

Primary outcome [1]

Adverse events reported (by diary): Pain and tenderness at the site of the injection (the Toxicity grading scale for vaccines - Mild: mild discomfort to touch, Moderate: Discomfort with movement, Severe: Significant discomfort at rest) redness and swelling (measured in mm). On each evening for 7 days after vaccination, children will be asked to rate how painful /tender their arm is where they received the vaccination at rest and during movement. Parents will be asked to measure and record any swelling and/or redness with an evaluation card provided. In addition, parents will be asked to record any use of medication, fever, drowsiness, malaise or anorexia in the child.

Timepoint [1]

Days 1-7 post vaccination, for each of the 3 vaccine dose (baseline, 2 months, 6 months)

Primary outcome [2]

Pain (immediately after vaccination) and during 7 days following vaccination (Wong-Baker FACES Pain Scale- revised)

Timepoint [2]

Immediately post each vaccine dose, and once daily for 7 days post each vaccination

Primary outcome [3]

Redness and swelling at site of injection (measured in mm) during 7 days following each dose of vaccine

Timepoint [3]

Once daily for 7 days post each vacination

Secondary outcome [1]

Antibody titre (dried blood spot and serum assays)

Timepoint [1]

6 months post first dose of vaccine (immediately prior to receiving dose 3), and 7 months post first dose of vaccine

Secondary outcome [2]

Fear of vaccination (The Children's Fear scale)

Timepoint [2]

Immediately after each dose of vaccine

Eligibility

Key inclusion criteria

Eligible children are aged 11-13 years, in year 7, have not previously received the HPV vaccine, and have no contraindications to vaccination against HPV. They must provide a signed parental consent form to both participate in the year 7 HPV school vaccination program and to participate in this study. Only participants fluent in English will be considered for participation. This is to ensure that there is good communication between investigators and participants, which will increase patient compliance and the correct completion of exercise task.

Minimum age

11 Years

Maximum age

13 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Contraindication to vaccination as listed in the most current Immunisation Handbook, including anyone who has experienced an anaphylactic reaction to any component of the vaccine (including yeast) or following a previous dose of vaccine; history of vaccine related allergies or side-effects; current immune disorder (e.g. glandular fever) or acute infection; pregnant or suspected pregnancy; current medication (e.g., prescription medication, anti-inflammatories). Children with thrombocytopenia or any coagulation disorder will also be excluded because bleeding may occur following an intramuscular administration in these individuals. Any condition that prevents vigorous exercise.

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)

On enrollment and receipt of parental consent, children will be allocated the next available study number. Study numbers will be linked to randomised list allocating to Exercise or Control groups. Allocation was concealed by central randomisation by computer, with allocations placed in sealed, opaque envelopes.

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

Computer generated randomised sequence, separate lists generated for males and females to maintain equal gender balance in groups

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

Pilot data from our previous studies shows that incidence of adverse event reports was lower in exercise groups than controls. In studies using the influenza (N=60) and Hepatitis B (N=78) vaccines, exercise groups reported adverse events significantly less often (15% and 24% respectively) than control groups (45% and 53% respectively). Both these vaccines show far lower rates of adverse events than the HPV vaccine; however, in order to maximize our ability to detect significant differences, we conducted Power calculations predicting a modest 25% difference between groups. Power calculations indicate that expecting a reduction of rate of adverse event reporting of 25% (e.g. 80% in control group and 55% in exercise group), a sample size of 62 per group is necessary. Given that a drop-out rate of >10% from dose 1 to dose 3 is expected, we will recruit N=150 children with N=75 per group.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/03/2015

Actual

1/04/2015

Date of last participant enrolment

Anticipated

Actual

6/06/2016

Date of last data collection

Anticipated

Actual

20/12/2016

Sample size

Target

150

Accrual to date

Final

116

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Financial Markets Foundation for Children

Address [1]

Foundation for Children GPO Box 3655 Sydney NSW 2000

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

University of Sydney,
Faculty of Health Sciences,
PO Box 170
Lidcombe, NSW, 1825

Country

Australia

Secondary sponsor category [1]

Other Collaborative groups

Name [1]

National Centre for Immunisation Research and Surveillance

Address [1]

NCIRS, Kids Research Institute at The Children's Hospital at Westmead Cnr Hawkesbury Rd & Hainsworth St, Westmead NSW 2145

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney HREC

Ethics committee address [1]

Research Integrity
Research Portfolio
Level 6, Jane Foss Russell
The University of Sydney
NSW 2006 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/11/2014

Approval date [1]

03/03/2015

Ethics approval number [1]

Ethics committee name [2]

Sydney Children’s Hospital Network Human Research Ethics Committee

Ethics committee address [2]

Corner Hawkesbury Road
and Hainsworth Street
Locked Bag 4001
Westmead NSW 2145

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

20/03/2015

Approval date [2]

01/04/2015

Ethics approval number [2]

HREC/15/SCHN/107

Summary

Brief summary

HPV is a sexually-transmitted infection that can lead to several cancers. HPV vaccination is an important way to protect against these cancers, so it’s important that vaccination rates are high and teenage girls and boys complete all 3 doses of vaccines. Exercising at the time of getting the vaccine might be a way to stop some of the side effects children often experience, like pain and redness, and improve the experience of vaccination, helping improve vaccination rates. In this study we will test if a 15 minute exercise task changes the number of adverse event reports, we hypothesise that an exercise task will reduce the number of children who suffer an adverse event like pain and redness at the injection site.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Kate Edwards

Address

Exercise Health and Performance Research Group University of Sydney, Cumberland Campus PO Box 170 Lidcombe, NSW, 1825

Country

Australia

Phone

+61 2 9036 7396

Fax

[email protected]

Contact person for public queries

Name

Kate Edwards

Address

Exercise Health and Performance Research Group University of Sydney, Cumberland Campus PO Box 170 Lidcombe, NSW, 1825

Country

Australia

Phone

+61 2 9036 7396

Fax

[email protected]

Contact person for scientific queries

Name

Kate Edwards

Address

Exercise Health and Performance Research Group University of Sydney, Cumberland Campus PO Box 170 Lidcombe, NSW, 1825

Country

Australia

Phone

+61 2 9036 7396

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers who request data from PI

Conditions for requesting access:
• -

What individual participant data might be shared?

• Raw data available on request after publication requirements fulfilled

What types of analyses could be done with individual participant data?

• Systematic review / meta analysis

When can requests for individual participant data be made (start and end dates)?

From:
To be determined dependent on publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• email to PI

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
421	Ethical approval					Study-related document.pdf

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	The effect of exercise on local and systemic adverse reactions after vaccinations - Outcomes of two randomized controlled trials.	2018	https://dx.doi.org/10.1016/j.vaccine.2018.09.067
Embase	The effect of exercise on vaccine-related pain, anxiety and fear during HPV vaccinations in adolescents.	2018	https://dx.doi.org/10.1016/j.vaccine.2018.04.069

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

Trial Review

Documents added manually

Documents added automatically