The Effects of Planned Intravenous Antibiotics on Activity in CF V2.0
Research type
Research Study
Full title
The effects of planned intravenous antibiotic course on activity in children with cystic fibrosis - objective measurement of physical activity, sedentary behaviour, and sleep duration in children with cystic fibrosis.
IRAS ID
223350
Contact name
Ross Langley
Contact email
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
2 years, 6 months, 28 days
Research summary
Why - This study aims to investigate the effect of planned intravenous (IV) antibiotic course on the activity levels of children and adolescents (aged 5 -16 years) with Cystic Fibrosis - with the hypothesis that activity levels are significantly reduced by these courses. It is known that a reduction in activity levels adversely affects the lung function in these patients, and with potentially four two week planned intravenous antibiotic course per annum this could have a significant impact on their health. If our hypothesis is found to be correct this will influence the allocation of funding to provide activity programmes for our inpatients.
What? Measuring activity levels in children and adolescents with Cystic Fibrosis two weeks prior, during and two weeks after course of planned IV antibiotics using validated questionnaires and actigraphy (an activity monitor which is worn like a a watch).
Who? All patients with cystic fibrosis undergoing a course of planned IV antibiotics who have no mobility issues and were able to comply with both questionnaire and wearing of actigraphy monitors
Where? Patients will be identified by their direct care team from Cystic Fibrosis Team records. Physical activity questionnaires and sleep diaries will be provided at clinical contact for each epoch. Actigraph will be provided at clinical contact and worn for the two weeks prior, during and after antibiotic course.
How? Each patient will be part of the study for six weeks and recruitment will run for two year. Each patient will fill in a physical activity questionnaire and sleep diary for their activity two weeks prior to course, during and two weeks following. The will wear the actigraph for the six weeks.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0095
Date of REC Opinion
30 Sep 2021
REC opinion
Further Information Favourable Opinion