None listed
Conditions
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.
Interventions
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
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)
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
11 Years to 13 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed