Study protocol for Chronic Obstructive Pulmonary Disease-Sitting and ExacerbAtions Trial (COPD-SEAT): a randomised controlled feasibility trial of a home-based self-monitoring sedentary behaviour intervention

Abstract

IntroductionAn acute exacerbation of chronic obstructive pulmonary disease (COPD) marks a critical life event, which can lower patient quality of life and ability to perform daily activities. Patients with COPD tend to lead inactive and highly sedentary lifestyles, which may contribute to reductions in functional capacity. Targeting sedentary behaviour (SB) may be more attainable than exercise (at a moderate-to-vigorous intensity) for behaviour change in patients following an exacerbation. This study aims to evaluate the feasibility and acceptability of a 2-week at-home intervention providing education and self-monitoring to reduce prolonged periods of SB in patients with COPD discharged following an acute exacerbation.Methods and analysisPatients will be randomised into 1 of 3 conditions: usual care (control), education or education+feedback. The education group will receive information and suggestions about reducing long periods of sitting. The education+feedback group will receive real-time feedback on their sitting time, stand-ups and step count at home through an inclinometer linked to a smart device app. The inclinometer will also provide vibration prompts to encourage movement when the wearer has been sedentary for too long. Data will be collected during hospital admission and 2 weeks after discharge. Qualitative interviews will be conducted with patients in the intervention groups to explore patient experiences. Interviews with healthcare staff will also be conducted. All data will be collected January to August 2016. The primary outcomes are feasibility and acceptability, which will be assessed by qualitative interviews, uptake and drop-out rates, reasons for refusing the intervention, compliance, app usage and response to vibration prompts.Ethics and disseminationThe research ethics committee East Midlands Leicester-Central has provided ethical approval for the conduct of this study. The results of the study will be disseminated through appropriate conference proceedings and peer-reviewed journals.Trial registration numberISRCTN13790881; Pre-results.

Findings of the Chronic Obstructive Pulmonary Disease-Sitting and Exacerbations Trial (COPD-SEAT) in Reducing Sedentary Time Using Wearable and Mobile Technologies With Educational Support: Randomized Controlled Feasibility Trial

“…The study design was a 3-armed feasibility randomized controlled trial (RCT) lasting 2 weeks following discharge from hospital, with 1:1:1 allocation. A detailed description of the study protocol has been published previously [ 15 ].The trial is reported in accordance with CONSORT-EHEALTH ( Multimedia Appendix 1 ). The study was approved by Research Ethics Committee East Midlands Leicester Central and all participants provided written informed consent (15/EM/0433).…”

“…Deliveries of the Education and Education+Feedback components of the intervention were audio recorded. Details of the intervention components (education booklet, application, and vibration prompts) have been previously reported [ 15 ]. Each component was coded separately by 2 trained, independent assessors using dichotomous scales (present or absent) for consistency and ordinal scales (poor, adequate, or excellent) for quality of delivery.…”

Physical activity, sedentary behaviour and sleep in COPD guidelines: A systematic review

“… 11 A simple search for studies exploring the effects of interventions specifically targeting time spent in sedentary behaviour identified a single protocol. 76 Similarly, while poor sleep quality is commonly reported by people with COPD 15 , 77 and has demonstrated associations with adverse physiological and psychological health outcomes, 14 – 16 few studies have explored therapeutic interventions to improve sleep in people with COPD without a coexisting sleep disorder. 78 – 81 …”

Findings of the Chronic Obstructive Pulmonary Disease-Sitting and Exacerbations Trial (COPD-SEAT) in Reducing Sedentary Time Using Wearable and Mobile Technologies With Educational Support: Randomized Controlled Feasibility Trial

“…A detailed description of the study protocol has been published previously [15].The trial is reported in accordance with CONSORT-EHEALTH (Multimedia Appendix 1). The study was approved by Research Ethics Committee East Midlands Leicester Central and all participants provided written informed consent (15/EM/0433).…”