Abstract
BackgroundRegular participation in physical activity by people with cystic fibrosis (CF) promotes positive clinical and health outcomes including reduced rate of decline in lung function, fewer hospitalizations and greater wellbeing. However adherence to exercise and activity programs is low, in part due to the substantial daily therapy burden for young people with CF. Strict infection control requirements limit the role of group exercise programs that are commonly used in other clinical groups. Investigation of methods to promote physical activity in this group has been limited. The Active Online Physical Activity in Cystic fibrosis Trial (ActionPACT) is an assessor-blinded, multi-centre, randomized controlled trial designed to compare the efficacy of a novel web-based program (ActivOnline) compared to usual care in promoting physical activity participation in adolescents and young adults with CF.MethodsAdolescents and young adults with CF will be recruited on discharge from hospital for a respiratory exacerbation. Participants randomized to the intervention group will have access to a web-based physical activity platform for the 12-week intervention period. ActivOnline allows users to track their physical activity, set goals, and self-monitor progress. All participants in both groups will be provided with standardised information regarding general physical activity recommendations for adolescents and young adults.Outcomes will be assessed by a blinded assessor at baseline, after completion of the intervention, and at 3-months followup. Healthcare utilization will be assessed at 12 months from intervention completion. The primary outcome is change in moderate-to-vigorous physical activity participation measured objectively by accelerometry. Secondary outcomes include aerobic fitness, health-related quality of life, anxiety and depression and sleep quality.DiscussionThis trial will establish whether a web-based application can improve physical activity participation more effectively than usual care in the period following hospitalization for a respiratory exacerbation. The web-based application under investigation can be made readily and widely available to all individuals with CF, to support physical activity and exercise participation at a time and location of the user’s choosing, regardless of microbiological status.Trial registrationClinical trial registered on July 13, 2017 with the Australian and New Zealand Clinical Trials Register at (ACTRN12617001009303).
Highlights
Regular participation in physical activity by people with cystic fibrosis (CF) promotes positive clinical and health outcomes including reduced rate of decline in lung function, fewer hospitalizations and greater wellbeing
This paper describes the protocol for a randomized controlled trial testing a web-based application to promote physical activity in adolescents and young adults with CF
We hypothesise that the web-based intervention will improve uptake and participation in physical activity by young people with CF following a hospital admission for a respiratory exacerbation compared to usual care; that increased physical activity participation will lead to improvements in exercise capacity, lung function, quality of life, anxiety and depression, and sleep quality; and that healthcare utilization will be reduced in the intervention group over 12 months
Summary
Design A randomized, controlled, assessor-blinded trial will be conducted at eight Australian sites (Alfred Health, Monash Health and Royal Children’s Hospital, Victoria; Royal Hobart Hospital, Tasmania; Royal Prince Alfred Hospital, Westmead Hospital and Children’s Hospital at Westmead, New South Wales; Royal Adelaide Hospital, South Australia). ActivOnline intervention Participants randomized to the active intervention group will be given individualized access to the ActivOnline program (www.activonline.com.au) and encouraged to use this for the 12-week intervention period, to track their physical activity, set goals, and self-monitor progress This will be in addition to usual care. Analysis Sample size To detect a difference of 20-min per day in MVPA participation between ActivOnline and control groups following the intervention period, a total of 56 participants will be required This sample size was based on physical activity participation measured post hospitalisation in our population of young adults with CF [4] and assumes a standard deviation of 26 [4] with a power of 80% and a significance level of p < 0.05. Study withdrawal will not have any impact on care provided by any of the participating sites
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