Steps Ahead: optimising physical activity in adults with cystic fibrosis: Study Protocolfor a pilot randomised trial using wearable technology.

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

doi:10.12688/hrbopenres.13025.2

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; wearable technology, smartphone use and remote monitoring, all of which may have potential to impact on PA in adults with CF. The objective of this pilot randomised trial is to explore the effect of wearable technology, which is remotely monitored, combined with personalised text message feedback and goal setting, on PA in adults with CF. Secondary endpoints include lung function, aerobic capacity, quality of life, body composition, wellbeing and sleep. 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 wearable technology (Fitbit Charge 2) which is linked to an online monitoring system (Fitabase) that enables the physiotherapist to remotely monitor participant data. The CF physiotherapist will set individualised PA goals with each participant at baseline and will send text message feedback each week.The text messages will be personalised, one-way texts with positive reinforcement on step count attained by the participant.The active comparator group will receive this wearable technology 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. A semi structured interview will assess satisfaction and acceptability of the intervention. Discussion: This is a novel concept which utilises modern technology, remote monitoring and personalised feedback to investigate the effect on PA in adults 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)
Any reports and responses or comments on the article can be found at the end of the article. This is a novel concept which utilises modern technology, remote monitoring and personalised feedback to investigate the effect on PA in adults with CF
Study design This study represents a single centre pilot randomised trial which will compare the effect of wearable technology with personalised text message feedback and goal setting to wearable technology alone in adults with CF

Summary

Introduction

Physical activity (PA) and exercise are widely documented as key components in the management of cystic fibrosis (CF). Setting specific goals should offer a plan to break PA goals into more practical, manageable steps ( Shilts et al, 2004) which should increase self-efficacy and promote continued regular PA levels ( Bandura, 2004). 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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