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@article{Nolan:2021:10.1136/bmjopen-2020-047524,
author = {Nolan, CM and Walsh, JA and Patel, S and Barker, RE and Polgar, O and Maddocks, M and Gao, W and Wilson, R and Fiorentino, F and Man, W},
doi = {10.1136/bmjopen-2020-047524},
journal = {BMJ Open},
pages = {1--8},
title = {Minimal versus specialist equipment in the delivery of pulmonary rehabilitation: protocol for a non-inferiority randomised controlled trial},
url = {http://dx.doi.org/10.1136/bmjopen-2020-047524},
volume = {11},
year = {2021}
}

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TY  - JOUR
AB  - 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
AU  - Nolan,CM
AU  - Walsh,JA
AU  - Patel,S
AU  - Barker,RE
AU  - Polgar,O
AU  - Maddocks,M
AU  - Gao,W
AU  - Wilson,R
AU  - Fiorentino,F
AU  - Man,W
DO  - 10.1136/bmjopen-2020-047524
EP  - 8
PY  - 2021///
SN  - 2044-6055
SP  - 1
TI  - Minimal versus specialist equipment in the delivery of pulmonary rehabilitation: protocol for a non-inferiority randomised controlled trial
T2  - BMJ Open
UR  - http://dx.doi.org/10.1136/bmjopen-2020-047524
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000709009700007&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - https://bmjopen.bmj.com/content/11/10/e047524
UR  - http://hdl.handle.net/10044/1/93064
VL  - 11
ER  -

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