Protocol update for a multi-centre randomised controlled trial of exercise rehabilitation for people with pulmonary hypertension: the SPHERe trial

Stuart Ennis; Julie Bruce; Harbinder Sandhu; Mariam Ratna; Ranjit Lall; Chen Ji; James Mason; Rebecca Kandiyali; Kate Seers; Prithwish Banerjee; Stephanie J C Taylor; Elizabeth Robertson; Martin Underwood; Gordon McGregor

doi:10.1186/s13063-024-08341-0

Protocol update for a multi-centre randomised controlled trial of exercise rehabilitation for people with pulmonary hypertension: the SPHERe trial

Stuart Ennis, Julie Bruce, Harbinder Sandhu, Mariam Ratna, Ranjit Lall, Chen Ji, James Mason, Rebecca Kandiyali, Kate Seers, Prithwish Banerjee, Stephanie J C Taylor, Elizabeth Robertson, Martin Underwood, Gordon McGregor

Centre for Healthcare and Communities

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Abstract

Background: The SPHERe (Supervised Pulmonary Hypertension Exercise Rehabilitation) trial is a multi-centre, pragmatic, randomised controlled trial assessing the clinical and cost-effectiveness of supervised exercise rehabilitation with psychosocial and motivational support compared to best-practice usual care for people with pulmonary hypertension (PH). The original protocol was published in BMC Pulmonary Medicine (accessible online). We randomised our first participant in January 2020. In response to the COVID-19 pandemic, the trial was stopped in March 2020. In person delivery of the SPHERe intervention to a vulnerable population was not possible during the COVID-19 pandemic. We describe here how trial procedures and intervention delivery were adapted in response to the COVID-19 pandemic.

Methods: Restrictions imposed by the COVID-19 pandemic on the clinically vulnerable PH population meant that trial delivery was changed from a centre-based rehabilitation programme to remotely delivered group online sessions. This led to minor alterations to the eligibility criteria. These changes followed a consultation process with stakeholders and people with PH and were approved by the funder and independent trial committees.

Conclusions: We describe the modified SPHERe trial protocol in response to restrictions imposed by the COVID-19 pandemic. SPHERe is the first randomised controlled trial to assess the clinical and cost-effectiveness of an online group rehabilitation programme for people with PH compared to usual care.

Trial registration: ISRCTN no. 10608766. Prospectively registered on 18th March 2019, updated 16th August 2023.

Original language	English
Article number	495
Number of pages	6
Journal	Trials
Volume	25
Issue number	1
DOIs	https://doi.org/10.1186/s13063-024-08341-0
Publication status	Published - 20 Jul 2024

Bibliographical note

This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Funder

This trial is funded by the National Institute for Health Research (NIHR) HTA programme: 17/129/02.

Funding

This trial is funded by the National Institute for Health Research (NIHR) HTA programme: 17/129/02. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

Funders	Funder number
National Institute for Health and Care Research	17/129/02

Keywords

Pulmonary hypertension
Cardiopulmonary rehabilitation
Complex intervention
Online exercise

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10.1186/s13063-024-08341-0Licence: CC BY

McGregor2024VoRFinal published version, 1.17 MBLicence: CC BY

Cite this

Ennis, S., Bruce, J., Sandhu, H., Ratna, M., Lall, R., Ji, C., Mason, J., Kandiyali, R., Seers, K., Banerjee, P., Taylor, S. J. C., Robertson, E., Underwood, M., & McGregor, G. (2024). Protocol update for a multi-centre randomised controlled trial of exercise rehabilitation for people with pulmonary hypertension: the SPHERe trial. Trials, 25(1), Article 495. https://doi.org/10.1186/s13063-024-08341-0

Ennis, S, Bruce, J, Sandhu, H, Ratna, M, Lall, R, Ji, C, Mason, J, Kandiyali, R, Seers, K, Banerjee, P, Taylor, SJC, Robertson, E, Underwood, M & McGregor, G 2024, 'Protocol update for a multi-centre randomised controlled trial of exercise rehabilitation for people with pulmonary hypertension: the SPHERe trial', Trials, vol. 25, no. 1, 495. https://doi.org/10.1186/s13063-024-08341-0

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abstract = "Background: The SPHERe (Supervised Pulmonary Hypertension Exercise Rehabilitation) trial is a multi-centre, pragmatic, randomised controlled trial assessing the clinical and cost-effectiveness of supervised exercise rehabilitation with psychosocial and motivational support compared to best-practice usual care for people with pulmonary hypertension (PH). The original protocol was published in BMC Pulmonary Medicine (accessible online). We randomised our first participant in January 2020. In response to the COVID-19 pandemic, the trial was stopped in March 2020. In person delivery of the SPHERe intervention to a vulnerable population was not possible during the COVID-19 pandemic. We describe here how trial procedures and intervention delivery were adapted in response to the COVID-19 pandemic.Methods: Restrictions imposed by the COVID-19 pandemic on the clinically vulnerable PH population meant that trial delivery was changed from a centre-based rehabilitation programme to remotely delivered group online sessions. This led to minor alterations to the eligibility criteria. These changes followed a consultation process with stakeholders and people with PH and were approved by the funder and independent trial committees.Conclusions: We describe the modified SPHERe trial protocol in response to restrictions imposed by the COVID-19 pandemic. SPHERe is the first randomised controlled trial to assess the clinical and cost-effectiveness of an online group rehabilitation programme for people with PH compared to usual care.Trial registration: ISRCTN no. 10608766. Prospectively registered on 18th March 2019, updated 16th August 2023.",

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AU - Ratna, Mariam

AU - Lall, Ranjit

AU - Ji, Chen

AU - Mason, James

AU - Kandiyali, Rebecca

AU - Seers, Kate

AU - Banerjee, Prithwish

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AU - Robertson, Elizabeth

AU - Underwood, Martin

AU - McGregor, Gordon

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N2 - Background: The SPHERe (Supervised Pulmonary Hypertension Exercise Rehabilitation) trial is a multi-centre, pragmatic, randomised controlled trial assessing the clinical and cost-effectiveness of supervised exercise rehabilitation with psychosocial and motivational support compared to best-practice usual care for people with pulmonary hypertension (PH). The original protocol was published in BMC Pulmonary Medicine (accessible online). We randomised our first participant in January 2020. In response to the COVID-19 pandemic, the trial was stopped in March 2020. In person delivery of the SPHERe intervention to a vulnerable population was not possible during the COVID-19 pandemic. We describe here how trial procedures and intervention delivery were adapted in response to the COVID-19 pandemic.Methods: Restrictions imposed by the COVID-19 pandemic on the clinically vulnerable PH population meant that trial delivery was changed from a centre-based rehabilitation programme to remotely delivered group online sessions. This led to minor alterations to the eligibility criteria. These changes followed a consultation process with stakeholders and people with PH and were approved by the funder and independent trial committees.Conclusions: We describe the modified SPHERe trial protocol in response to restrictions imposed by the COVID-19 pandemic. SPHERe is the first randomised controlled trial to assess the clinical and cost-effectiveness of an online group rehabilitation programme for people with PH compared to usual care.Trial registration: ISRCTN no. 10608766. Prospectively registered on 18th March 2019, updated 16th August 2023.

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Protocol update for a multi-centre randomised controlled trial of exercise rehabilitation for people with pulmonary hypertension: the SPHERe trial

Abstract

Bibliographical note

Funder

Funding

Keywords

Access to Document

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Supervised pulmonary hypertension exercise rehabilitation (SPHERe): Study protocol for a multi-centre randomised controlled trial

Cite this