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Minimal versus specialist equipment in the delivery of pulmonary rehabilitation: Protocol for a non-inferiority randomised controlled trial

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Claire M. Nolan, Jessica A. Walsh, Suhani Patel, Ruth E. Barker, Oliver Polgar, Matthew Maddocks, Wei Gao, Rebecca Wilson, Francesca Fiorentino, William Man

Original languageEnglish
Article numbere047524
JournalBMJ Open
Volume11
Issue number10
DOIs
Published18 Oct 2021

Bibliographical note

Funding Information: Funding This work is supported by National Institute for Health Research grant number PB-PG-0816–20022. Funding Information: Competing interests CMN reports fees from Novartis outside of this research. MM consultancy fees from Fresenius Kabi and Helsinn, grants from National Institute for Health Research, grants from British Lung Foundation, outside the submitted work. WM reports personal fees from Jazz Pharmaceuticals, personal fees from Mundipharma, personal fees from Novartis, grants from Pfizer, non-financial support from GSK, grants from National Institute for Health Research, grants from British Lung Foundation, outside the submitted work. Publisher Copyright: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

King's Authors

Abstract

Introduction Pulmonary rehabilitation (PR), an exercise and education programme for people with chronic lung disease, aims to improve exercise capacity, breathlessness and quality of life. Most evidence to support PR is from trials that use specialist exercise equipment, for example, treadmills (PR-gym). However, a significant proportion of programmes do not have access to specialist equipment with training completed with minimal exercise equipment (PR-min). There is a paucity of robust literature examining the efficacy of supervised, centre-based PR-min. We aim to determine whether an 8-week supervised, centre-based PR-min programme is non-inferior to a standard 8-week supervised, centre-based PR-gym programme in terms of exercise capacity and health outcomes for patients with chronic lung disease. Methods and analysis Parallel, two-group, assessor-blinded and statistician-blinded, non-inferiority randomised trial. 436 participants will be randomised using minimisation at the individual level with a 1:1 allocation to PR-min (intervention) or PR-gym (control). Assessment will take place pre-PR (visit 1), post-PR (visit 2) and 12 months following visit 1 (visit 3). Exercise capacity (incremental shuttle walk test), dyspnoea (Chronic Respiratory Questionnaire (CRQ)-Dyspnoea), health-related quality of life (CRQ), frailty (Short Physical Performance Battery), muscle strength (isometric quadriceps maximum voluntary contraction), patient satisfaction (Global Rating of Change Questionnaire), health economic as well as safety and trial process data will be measured. The primary outcome is change in exercise capacity between visit 1 and visit 2. Two sample t-tests on an intention to treat basis will be used to estimate the difference in mean primary and secondary outcomes between patients randomised to PR-gym and PR-min. Ethics and dissemination London-Camden and Kings Cross Research Ethics Committee and Health Research Authority have approved the study (18/LO/0315). Results will be submitted for publication in peer-reviewed journals, presented at international conferences, disseminated through social media, patient and public routes and directly shared with stakeholders. Trial registration number ISRCTN16196765.

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