Development of a complex exercise rehabilitation intervention for people with pulmonary hypertension: the supervised pulmonary hypertension exercise rehabilitation (SPHERe) trial

Background People with pulmonary hypertension (PH) are not routinely referred for exercise rehabilitation despite the potential for reducing breathlessness and improving quality of life. We describe the development of a supervised pulmonary hypertension exercise rehabilitation (SPHERe) programme for...

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Main Authors: Gordon McGregor, Martin Underwood, Julie Bruce, Kate Seers, Harbinder Kaur Sandhu, Stuart Ennis, Tamar Pincus
Format: Article
Language:English
Published: BMJ Publishing Group 2023-08-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/13/8/e066053.full
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author Gordon McGregor
Martin Underwood
Julie Bruce
Kate Seers
Harbinder Kaur Sandhu
Stuart Ennis
Tamar Pincus
author_facet Gordon McGregor
Martin Underwood
Julie Bruce
Kate Seers
Harbinder Kaur Sandhu
Stuart Ennis
Tamar Pincus
author_sort Gordon McGregor
collection DOAJ
description Background People with pulmonary hypertension (PH) are not routinely referred for exercise rehabilitation despite the potential for reducing breathlessness and improving quality of life. We describe the development of a supervised pulmonary hypertension exercise rehabilitation (SPHERe) programme for people with PH.Methods Development was completed in three phases: (1) systematic review, (2) stakeholder engagement with consensus from patients and experts and (3) prepilot intervention acceptability testing. We completed systematic reviews to identify international cardiopulmonary rehabilitation guidance and trials of exercise-based interventions for people with PH. Evidence from systematic reviews and stakeholder consensus shaped the SPHERe intervention, including addition of individual behavioural support sessions to promote exercise adherence. The draft SPHERe intervention was ratified through discussions with multidisciplinary professionals and people living with PH. We acceptability tested the centre-based intervention with eight participants in a prepilot development phase which identified a number of condition-specific issues relating to safety and fear avoidance of activity. Comprehensive intervention practitioner training manuals were produced to ensure standardised delivery. Participant workbooks were developed and piloted. Trial recruitment began in January 2020 but was subsequently suspended in March 2020 further to COVID-19 pandemic ‘lockdowns’. In response to the pandemic, we undertook further development work to redesign the intervention to be suitable for exclusively home-based online delivery. Recruitment to the revised protocol began in June 2021.Discussion The final SPHERe intervention incorporated weekly home-based online group exercise and behavioural support ‘coaching’ sessions supervised by trained practitioners, with a personalised home exercise plan and the optional loan of a stationary exercise bike. The intervention was fully manualised with clear pathways for assessment and individualised exercise prescription. The clinical and cost-effectiveness of the SPHERe online rehabilitation intervention is currently being tested in a UK multicentre randomised controlled trial.Trial registration number ISCRTN10608766.
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spelling doaj.art-e86a45613a07496886a538373493f7d52024-11-14T17:55:11ZengBMJ Publishing GroupBMJ Open2044-60552023-08-0113810.1136/bmjopen-2022-066053Development of a complex exercise rehabilitation intervention for people with pulmonary hypertension: the supervised pulmonary hypertension exercise rehabilitation (SPHERe) trialGordon McGregor0Martin Underwood1Julie Bruce2Kate Seers3Harbinder Kaur Sandhu4Stuart Ennis5Tamar Pincus6University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK7 Warwick Clinical Trials Unit, Health Sciences Research Institute, University of Warwick, Coventry, UKClinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UKprofessor of health research3 Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UKclinical research fellowPsychology, Royal Hollaway University of London, London, UKBackground People with pulmonary hypertension (PH) are not routinely referred for exercise rehabilitation despite the potential for reducing breathlessness and improving quality of life. We describe the development of a supervised pulmonary hypertension exercise rehabilitation (SPHERe) programme for people with PH.Methods Development was completed in three phases: (1) systematic review, (2) stakeholder engagement with consensus from patients and experts and (3) prepilot intervention acceptability testing. We completed systematic reviews to identify international cardiopulmonary rehabilitation guidance and trials of exercise-based interventions for people with PH. Evidence from systematic reviews and stakeholder consensus shaped the SPHERe intervention, including addition of individual behavioural support sessions to promote exercise adherence. The draft SPHERe intervention was ratified through discussions with multidisciplinary professionals and people living with PH. We acceptability tested the centre-based intervention with eight participants in a prepilot development phase which identified a number of condition-specific issues relating to safety and fear avoidance of activity. Comprehensive intervention practitioner training manuals were produced to ensure standardised delivery. Participant workbooks were developed and piloted. Trial recruitment began in January 2020 but was subsequently suspended in March 2020 further to COVID-19 pandemic ‘lockdowns’. In response to the pandemic, we undertook further development work to redesign the intervention to be suitable for exclusively home-based online delivery. Recruitment to the revised protocol began in June 2021.Discussion The final SPHERe intervention incorporated weekly home-based online group exercise and behavioural support ‘coaching’ sessions supervised by trained practitioners, with a personalised home exercise plan and the optional loan of a stationary exercise bike. The intervention was fully manualised with clear pathways for assessment and individualised exercise prescription. The clinical and cost-effectiveness of the SPHERe online rehabilitation intervention is currently being tested in a UK multicentre randomised controlled trial.Trial registration number ISCRTN10608766.https://bmjopen.bmj.com/content/13/8/e066053.full
spellingShingle Gordon McGregor
Martin Underwood
Julie Bruce
Kate Seers
Harbinder Kaur Sandhu
Stuart Ennis
Tamar Pincus
Development of a complex exercise rehabilitation intervention for people with pulmonary hypertension: the supervised pulmonary hypertension exercise rehabilitation (SPHERe) trial
BMJ Open
title Development of a complex exercise rehabilitation intervention for people with pulmonary hypertension: the supervised pulmonary hypertension exercise rehabilitation (SPHERe) trial
title_full Development of a complex exercise rehabilitation intervention for people with pulmonary hypertension: the supervised pulmonary hypertension exercise rehabilitation (SPHERe) trial
title_fullStr Development of a complex exercise rehabilitation intervention for people with pulmonary hypertension: the supervised pulmonary hypertension exercise rehabilitation (SPHERe) trial
title_full_unstemmed Development of a complex exercise rehabilitation intervention for people with pulmonary hypertension: the supervised pulmonary hypertension exercise rehabilitation (SPHERe) trial
title_short Development of a complex exercise rehabilitation intervention for people with pulmonary hypertension: the supervised pulmonary hypertension exercise rehabilitation (SPHERe) trial
title_sort development of a complex exercise rehabilitation intervention for people with pulmonary hypertension the supervised pulmonary hypertension exercise rehabilitation sphere trial
url https://bmjopen.bmj.com/content/13/8/e066053.full
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