1 Alqahtani KA, et al. BMJ Open 2022;12:e055513. doi:10.1136/bmjopen-2021-055513 Open access SPACE FOR COPD delivered as a maintenance programme on pulmonary rehabilitation discharge: protocol of a randomised controlled trial evaluating the long-term effects on exercise tolerance and mental well-being Khaled A Alqahtani , 1,2 Charlotte Gerlis, 3 Claire M Nolan , 4 Nikki Gardiner, 3 Ala Szczepura , 5 William Man, 4,6 Sally J Singh, 2,3 Linzy Houchen-Wolloff 2,3 To cite: Alqahtani KA, Gerlis C, Nolan CM, et al. SPACE FOR COPD delivered as a maintenance programme on pulmonary rehabilitation discharge: protocol of a randomised controlled trial evaluating the long-term effects on exercise tolerance and mental well-being. BMJ Open 2022;12:e055513. doi:10.1136/ bmjopen-2021-055513 ► Prepublication history for this paper are available online. To view these fles, please visit the journal online (http://dx.doi. org/10.1136/bmjopen-2021- 055513). Received 02 August 2021 Accepted 08 March 2022 For numbered affliations see end of article. Correspondence to Dr Linzy Houchen-Wolloff; Linzy.Houchen@uhl-tr.nhs.uk Protocol © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. ABSTRACT Introduction The benefts achieved during pulmonary rehabilitation (PR) are known to be sustained for 6–12 months after the initial programme. Several maintenance trials have been conducted but were heterogeneous in terms of duration, frequency and labour cost. There is no consensus on one best strategy. SPACE FOR COPD (Self-management Programme of Activity, Coping and Education for Chronic Obstructive Pulmonary Disease) is a home-based self-management programme, which has been shown previously to be effective in primary and secondary care settings and is to be tested here as a maintenance programme. The aim is to evaluate the effcacy of the SPACE FOR COPD programme (manual and group sessions), on exercise tolerance and mental well- being, compared with usual care following PR in patients with COPD. Methods and analysis A prospective, multicentre, single-blinded randomised controlled trial requiring 116 participants with a clinical diagnosis of COPD who have fnished PR within 4 weeks will be randomised 1:1 to either a usual care group or a SPACE FOR COPD programme group. The intervention comprises a home- based manual and 4, 2-hour group sessions adopting motivational interviewing techniques over 12 months. The primary outcome is endurance capacity measured by the Endurance Shuttle Walking Test at 12 months. Secondary outcomes are: maximal exercise capacity, health-related quality of life, mood, patient activation, physical activity, lung function and healthcare costs. The measures will be taken at baseline, 6 and 12 months. Patient interviews and staff focus groups will be conducted to explore barriers, facilitators and views about the intervention at the end of the study. A framework analysis will be used for the interpretation of qualitative data. Ethics and dissemination The trial was granted ethical approval from Health Research Authority and Health and Care Research Wales (HCRW19/EM/0267 on 10 October 2019). Results will be made available to all stakeholders through a dissemination event, conferences and peer- reviewed publications. Trial registration number ISRCTN30110012. INTRODUCTION To effectively manage chronic obstructive pulmonary disease (COPD), current national 1 and international 2 clinical guidelines recom- mend the addition of pulmonary rehabil- itation (PR) to standard pharmacological therapy. PR is a non-pharmacological inter- vention known to help manage and improve respiratory symptoms in stable COPD condi- tions 3 and is also recommended following a hospital admission for acute exacerbation of COPD. 1 Moreover, PR is beneficial to improve exercise capacity, 3 4 breathlessness, 3 quality of life (QoL), 5 anxiety and depression, 6 and reduce healthcare utilisation. 7 However, these benefits may only be sustained for 6–12 months after PR. 4 A number of factors may Strengths and limitations of this study ► This is a novel maintenance trial that uses an evidence-based home-based manual integrated with motivational interviewing skills to promote long-term self-management and behavioural change. ► Patients with chronic obstructive pulmonary disease who are registered in our patient and public involve- ment group were invited to review the protocol and two were involved in every aspect of developing the project. ► This is a multicentre trial, therefore the results may be more generalisable than a single centre. ► The programme is limited to English speakers only who can read at the level of an 8 year old. This may, therefore, exclude those who do not read in English or have low literacy. on December 7, 2023 by guest. Protected by copyright. http://bmjopen.bmj.com/ BMJ Open: first published as 10.1136/bmjopen-2021-055513 on 25 April 2022. Downloaded from