Steps Ahead: optimising physical activity and health in people with cystic fibrosis: Study Protocol for a pilot randomised trial

Maire Curran,Ali Sheikhi,Audrey C Tierney,Louise Collins,Lauren Kennedy,Brenda Button,Andrew J Jurascheck,Brian Casserly,Ciara Mcdonnell,Cathal Walsh,Rose Galvin,Roisin Cahalan

doi:10.12688/hrbopenres.13025.1

Abstract

Background: Physical activity (PA) and exercise are widely documented as key components in the management of cystic fibrosis (CF). In recent years there have been significant improvements in telehealth, in particular; fitness tracking, smartphone use and remote monitoring, all of which may have potential to impact on positive health outcomes in people with CF. The objective of this pilot randomised trial is to explore the potential efficacy of a fitness tracker, which is remotely monitored, combined with personalised text message feedback and goal setting, on lung function, aerobic capacity and PA in adults with CF. Secondary endpoints include quality of life, body composition and wellbeing. Methods: This is a pilot randomised trial which will be conducted at the University Hospital Limerick, Ireland. Participants will be randomised to the intervention or active comparator after their baseline assessment. The 12-week intervention will consist of a fitness tracker (Fitbit Charge 2) which is linked to an online monitoring system (Fitabase) for data collection purposes that enables the physiotherapist to remotely monitor participant data. The CF physiotherapist will set short- and long-term goals with participants and will send one-way text message feedback on Fitbit data and weekly progress. This message will consist of positive reinforcement and re-assess participant goals. The active comparator group will receive a fitness tracker which is also linked to Fitabase; however, no feedback will be provided to participants in this group. Both groups will be re-assessed at 12 weeks. After this point, both groups will continue with the Fitbit alone for a further 12 weeks. Both groups will be re-assessed at 24 weeks. Discussion: This is a novel concept which utilises modern technology, remote monitoring and personalised feedback to investigate the effect on health outcomes in people with CF. Trial registration: ClinicalTrials.gov NCT03672058 (14/09/2018)

Highlights

Physical activity (PA) and exercise are widely documented as key components in the management of cystic fibrosis (CF)
Study status Recruitment began in January 2019. It is anticipated this will be completed by June 2020. This is the first study to assess the potential efficacy of a fitness tracker with personalised feedback and goal setting on key clinical outcomes in people with CF (PWCF)
Previous studies have investigated telehealth in CF (Cox et al, 2012) and while there is insufficient evidence to draw firm conclusions as of yet, it is worth investigating the effectiveness of telehealth on physical activity (PA) in PWCF

Summary

Introduction

Physical activity (PA) and exercise are widely documented as key components in the management of cystic fibrosis (CF). In recent years there have been significant improvements in telehealth, in particular; fitness tracking, smartphone use and remote monitoring, all of which may have potential to impact on positive health outcomes in people with CF The objective of this pilot randomised trial is to explore the potential efficacy of a fitness tracker, which is remotely monitored, combined with personalised text message feedback and goal setting, on lung function, aerobic capacity and PA in adults with CF. Previous literature from patient preference research and effective PA promotion approaches reports that successful strategies include targeting PA (Conn et al, 2008), the use of behavioural strategies such as feedback and goal setting (Conn et al, 2008, Kosma et al, 2005) (George et al, 2012) and the ability to self-monitor (Conn et al, 2008). Goal setting to increase PA in adults with CF is poorly investigated.”

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