Cargando…

Protocol update for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study

BACKGROUND: The PULSE (PostUraL tachycardia Syndrome Exercise) study is a randomised controlled trial assessing the feasibility of conducting a multicentre RCT testing supervised exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with...

Descripción completa

Detalles Bibliográficos
Autores principales: McGregor, Gordon, Evans, Becky, Sandhu, Harbinder, Simmonds, Jane, Joshi, Shivam, Devi, Gita, Zhupaj, Albiona, Holliday, Nikki, Pearce, Gemma, Patel, Chloe, Hee, Siew Wan, Powell, Richard, Heine, Peter, Patel, Shilpa, Kavi, Lesley, Bruce, Julie, Hayat, Sajad, Lim, Boon, Eftekhari, Helen, Panikker, Sandeep
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9077338/
https://www.ncbi.nlm.nih.gov/pubmed/35525992
http://dx.doi.org/10.1186/s40814-022-01056-6
_version_ 1784702099175505920
author McGregor, Gordon
Evans, Becky
Sandhu, Harbinder
Simmonds, Jane
Joshi, Shivam
Devi, Gita
Zhupaj, Albiona
Holliday, Nikki
Pearce, Gemma
Patel, Chloe
Hee, Siew Wan
Powell, Richard
Heine, Peter
Patel, Shilpa
Kavi, Lesley
Bruce, Julie
Hayat, Sajad
Lim, Boon
Eftekhari, Helen
Panikker, Sandeep
author_facet McGregor, Gordon
Evans, Becky
Sandhu, Harbinder
Simmonds, Jane
Joshi, Shivam
Devi, Gita
Zhupaj, Albiona
Holliday, Nikki
Pearce, Gemma
Patel, Chloe
Hee, Siew Wan
Powell, Richard
Heine, Peter
Patel, Shilpa
Kavi, Lesley
Bruce, Julie
Hayat, Sajad
Lim, Boon
Eftekhari, Helen
Panikker, Sandeep
author_sort McGregor, Gordon
collection PubMed
description BACKGROUND: The PULSE (PostUraL tachycardia Syndrome Exercise) study is a randomised controlled trial assessing the feasibility of conducting a multicentre RCT testing supervised exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with Postural Tachycardia Syndrome (PoTS). The original trial protocol was published in BMC Pilot & Feasibility Studies (accessible at 10.1186/s40814-020-00702-1). The PULSE intervention consists of (1) individual assessment; (2) 12-week, twice-weekly, supervised exercise training; (3) behavioural and motivational support; and (4) guided lifestyle physical activity. The control intervention is best-practice usual care with a single 30-min, one-to-one practitioner appointment, and general advice on safe and effective physical activity. Sixty-two people (aged 18–60 years) with a confirmed diagnosis of PoTS will be invited to enrol on a feasibility RCT with an embedded qualitative study. The primary outcome will be feasibility; process-related measures will include eligibility, recruitment, randomisation and withdrawal rates, along with indicators of exercise programme adherence and acceptability. Secondary physiological, clinical and health-related outcomes will be assessed. In response to the COVID-19 pandemic, here we describe amendments to the trial protocol. METHODS: Restrictions imposed by the COVID-19 pandemic meant it was necessary to change the delivery of the PULSE and control interventions. These changes reflected the need to limit the risk of COVID-19 transmission in a clinical population, some of whom were at increased risk of contracting the virus and suffering serious illness. The major change was that the originally intended centre-based PULSE and control interventions would now be delivered remotely on-line. Subsequently, there were minor changes to the participant eligibility criteria. These decisions followed an on-line co-creation session with people affected by PoTS, and relevant public and professional stakeholders. CONCLUSIONS: We present an update of the original trial protocol in response to the COVID-19 pandemic. No participants were recruited to the original protocol; thus, results will reflect the on-line delivery of the intervention. PULSE will be the first randomised trial to assess the feasibility of conducting a definitive multi-centre RCT testing supervised on-line exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with PoTS. TRIAL REGISTRATION: ISRCTN45323485 registered on 7 April 2020.
format Online
Article
Text
id pubmed-9077338
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-90773382022-05-08 Protocol update for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study McGregor, Gordon Evans, Becky Sandhu, Harbinder Simmonds, Jane Joshi, Shivam Devi, Gita Zhupaj, Albiona Holliday, Nikki Pearce, Gemma Patel, Chloe Hee, Siew Wan Powell, Richard Heine, Peter Patel, Shilpa Kavi, Lesley Bruce, Julie Hayat, Sajad Lim, Boon Eftekhari, Helen Panikker, Sandeep Pilot Feasibility Stud Update BACKGROUND: The PULSE (PostUraL tachycardia Syndrome Exercise) study is a randomised controlled trial assessing the feasibility of conducting a multicentre RCT testing supervised exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with Postural Tachycardia Syndrome (PoTS). The original trial protocol was published in BMC Pilot & Feasibility Studies (accessible at 10.1186/s40814-020-00702-1). The PULSE intervention consists of (1) individual assessment; (2) 12-week, twice-weekly, supervised exercise training; (3) behavioural and motivational support; and (4) guided lifestyle physical activity. The control intervention is best-practice usual care with a single 30-min, one-to-one practitioner appointment, and general advice on safe and effective physical activity. Sixty-two people (aged 18–60 years) with a confirmed diagnosis of PoTS will be invited to enrol on a feasibility RCT with an embedded qualitative study. The primary outcome will be feasibility; process-related measures will include eligibility, recruitment, randomisation and withdrawal rates, along with indicators of exercise programme adherence and acceptability. Secondary physiological, clinical and health-related outcomes will be assessed. In response to the COVID-19 pandemic, here we describe amendments to the trial protocol. METHODS: Restrictions imposed by the COVID-19 pandemic meant it was necessary to change the delivery of the PULSE and control interventions. These changes reflected the need to limit the risk of COVID-19 transmission in a clinical population, some of whom were at increased risk of contracting the virus and suffering serious illness. The major change was that the originally intended centre-based PULSE and control interventions would now be delivered remotely on-line. Subsequently, there were minor changes to the participant eligibility criteria. These decisions followed an on-line co-creation session with people affected by PoTS, and relevant public and professional stakeholders. CONCLUSIONS: We present an update of the original trial protocol in response to the COVID-19 pandemic. No participants were recruited to the original protocol; thus, results will reflect the on-line delivery of the intervention. PULSE will be the first randomised trial to assess the feasibility of conducting a definitive multi-centre RCT testing supervised on-line exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with PoTS. TRIAL REGISTRATION: ISRCTN45323485 registered on 7 April 2020. BioMed Central 2022-05-07 /pmc/articles/PMC9077338/ /pubmed/35525992 http://dx.doi.org/10.1186/s40814-022-01056-6 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis 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/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://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.
spellingShingle Update
McGregor, Gordon
Evans, Becky
Sandhu, Harbinder
Simmonds, Jane
Joshi, Shivam
Devi, Gita
Zhupaj, Albiona
Holliday, Nikki
Pearce, Gemma
Patel, Chloe
Hee, Siew Wan
Powell, Richard
Heine, Peter
Patel, Shilpa
Kavi, Lesley
Bruce, Julie
Hayat, Sajad
Lim, Boon
Eftekhari, Helen
Panikker, Sandeep
Protocol update for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study
title Protocol update for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study
title_full Protocol update for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study
title_fullStr Protocol update for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study
title_full_unstemmed Protocol update for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study
title_short Protocol update for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study
title_sort protocol update for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the pulse study
topic Update
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9077338/
https://www.ncbi.nlm.nih.gov/pubmed/35525992
http://dx.doi.org/10.1186/s40814-022-01056-6
work_keys_str_mv AT mcgregorgordon protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT evansbecky protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT sandhuharbinder protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT simmondsjane protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT joshishivam protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT devigita protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT zhupajalbiona protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT hollidaynikki protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT pearcegemma protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT patelchloe protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT heesiewwan protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT powellrichard protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT heinepeter protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT patelshilpa protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT kavilesley protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT brucejulie protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT hayatsajad protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT limboon protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT eftekharihelen protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy
AT panikkersandeep protocolupdateforarandomisedcontrolledfeasibilitytrialofexerciserehabilitationforpeoplewithposturaltachycardiasyndromethepulsestudy