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

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)