Exercise rehabilitation for people with postural tachycardia syndrome at two secondary care centres in the UK: the PULSE feasibility randomised controlled trial

Gordon McGregor; Becky Evans; Harbinder Kaur Sandhu; Julie Bruce; Gita Devi; Sajad Ahmed Hayat; Siew Wan Hee; Peter Heine; Nikki Holliday; Shivam Joshi; Lesley Kavi; Boon Lim; Angela Noufaily; Nicholas Parsons; Shilpa  Patel; Gemma Pearce; Richard  Powell; Eva Schultz; Jane V. Simmonds; Albiona Zhupaj; Helen Eftekhari; Sandeep Panikker

doi:10.1136/bmjopen-2024-090197

Exercise rehabilitation for people with postural tachycardia syndrome at two secondary care centres in the UK: the PULSE feasibility randomised controlled trial

Gordon McGregor, Becky Evans, Harbinder Kaur Sandhu, Julie Bruce, Gita Devi, Sajad Ahmed Hayat, Siew Wan Hee, Peter Heine, Nikki Holliday, Shivam Joshi, Lesley Kavi, Boon Lim, Angela Noufaily, Nicholas Parsons, Shilpa Patel, Gemma Pearce, Richard Powell, Eva Schultz, Jane V. Simmonds, Albiona ZhupajHelen Eftekhari, Sandeep Panikker

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Abstract

Objectives The aim of the study was to assess the feasibility of conducting a definitive multicentre randomised controlled trial (RCT) testing an online exercise rehabilitation and behavioural/motivational support intervention for people with postural tachycardia syndrome (PoTS). Design Feasibility RCT. Setting Two secondary care centres. Participants Adults aged 18 to 60 years with PoTS. Exclusions were serious mental health/cognitive problem preventing safe participation; currently undertaking physical activity equivalent to the Chief Medical Officer guidelines; pregnancy. Interventions Participants were randomly assigned (1:1) to best-practice usual care (a single 1:1 session of advice) or the ‘postural tachycardia syndrome exercise’ (PULSE) intervention: (1) individual online consultation, (2) 12 weeks of supervised online group exercise and behavioural/motivational support, and (3) home exercise programme with recumbent exercise bike. Outcomes The primary outcome was feasibility: (1) patients screened, eligible, recruited, randomised, withdrawn; (2) adherence; (3) physiological, clinical and patient-reported outcomes (4 and 7 months); and (4) embedded qualitative study to evaluate acceptability. Results 209 patients screened between 5 May 2021 and 1 December 2022, 44 (female 98%; age 29.9 SD, 7.5) were randomised to usual care (n=21) or PULSE (n=23) (71% of target). Follow-up at 4 months was n=12 and n=17 respectively (66% of target). Median live exercise/ support session attendance was 15 (IQR 12 to 17) of 18 sessions. Home exercise bike usage was highly variable. There were two serious adverse events in each treatment arm, both unrelated to the trial. Exercise rehabilitation was considered important by participants, and trial procedures, outcomes and interventions were acceptable. Conclusions The PULSE trial procedures and interventions were acceptable, and important design considerations were identified. A definitive RCT testing a remotely supervised exercise rehabilitation and behavioural/motivational support intervention for people with PoTS is feasible in the UK National Health Service.

Original language	English
Article number	e090197
Number of pages	9
Journal	BMJ Open
Volume	15
Issue number	2
Early online date	22 Feb 2025
DOIs	https://doi.org/10.1136/bmjopen-2024-090197
Publication status	Published - 22 Feb 2025

Bibliographical note

This is an open access article distributed in accordance with the
Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits
others to copy, redistribute, remix, transform and build upon this work for any
purpose, provided the original work is properly cited, a link to the licence is given,
and indication of whether changes were made. See: https://creativecommons.org/
licenses/by/4.0/

Publisher Copyright:
© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group.

Funder

This study was funded by a British Heart Foundation (BHF) Project
Grant: (PG/19/22/34203)

Funding

GM is a director of Atrium Health Ltd, a non-profit cardiopulmonary rehabilitation provider, which provided the treatment hub for the PULSE trial. HS is a director of Health Psychology Services Ltd, a private health psychology provider. JB is supported by NIHR Research Capability Funding via university Hospitals Coventry and Warwickshire NHS Trust. HE is funded by a British Heart Foundation Nursing PhD fellowship award. LK is a trustee of PoTS UK. BE, GD, SH, SWH, PH, NH, SJ, PBL, AN, NP, SaP, GP, RP, ES, JS, AZ and ShP do not declare any competing interests. This study was funded by a British Heart Foundation (BHF) Project Grant: (PG/19/22/34203). The views expressed are those of the authors and not necessarily those of the BHF.

Funders	Funder number
National Institute for Health and Care Research
British Heart Foundation	PG/19/22/34203

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Cite this

McGregor, G., Evans, B., Sandhu, H. K., Bruce, J., Devi, G., Hayat, S. A., Hee, S. W., Heine, P., Holliday, N., Joshi, S., Kavi, L., Lim, B., Noufaily, A., Parsons, N., Patel, S., Pearce, G., Powell, R., Schultz, E., Simmonds, J. V., ... Panikker, S. (2025). Exercise rehabilitation for people with postural tachycardia syndrome at two secondary care centres in the UK: the PULSE feasibility randomised controlled trial. BMJ Open, 15(2), Article e090197. https://doi.org/10.1136/bmjopen-2024-090197

McGregor, G, Evans, B, Sandhu, HK, Bruce, J, Devi, G, Hayat, SA, Hee, SW, Heine, P, Holliday, N, Joshi, S, Kavi, L, Lim, B, Noufaily, A, Parsons, N, Patel, S, Pearce, G, Powell, R, Schultz, E, Simmonds, JV, Zhupaj, A, Eftekhari, H & Panikker, S 2025, 'Exercise rehabilitation for people with postural tachycardia syndrome at two secondary care centres in the UK: the PULSE feasibility randomised controlled trial', BMJ Open, vol. 15, no. 2, e090197. https://doi.org/10.1136/bmjopen-2024-090197

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abstract = "Objectives The aim of the study was to assess the feasibility of conducting a definitive multicentre randomised controlled trial (RCT) testing an online exercise rehabilitation and behavioural/motivational support intervention for people with postural tachycardia syndrome (PoTS). Design Feasibility RCT. Setting Two secondary care centres. Participants Adults aged 18 to 60 years with PoTS. Exclusions were serious mental health/cognitive problem preventing safe participation; currently undertaking physical activity equivalent to the Chief Medical Officer guidelines; pregnancy. Interventions Participants were randomly assigned (1:1) to best-practice usual care (a single 1:1 session of advice) or the {\textquoteleft}postural tachycardia syndrome exercise{\textquoteright} (PULSE) intervention: (1) individual online consultation, (2) 12 weeks of supervised online group exercise and behavioural/motivational support, and (3) home exercise programme with recumbent exercise bike. Outcomes The primary outcome was feasibility: (1) patients screened, eligible, recruited, randomised, withdrawn; (2) adherence; (3) physiological, clinical and patient-reported outcomes (4 and 7 months); and (4) embedded qualitative study to evaluate acceptability. Results 209 patients screened between 5 May 2021 and 1 December 2022, 44 (female 98%; age 29.9 SD, 7.5) were randomised to usual care (n=21) or PULSE (n=23) (71% of target). Follow-up at 4 months was n=12 and n=17 respectively (66% of target). Median live exercise/ support session attendance was 15 (IQR 12 to 17) of 18 sessions. Home exercise bike usage was highly variable. There were two serious adverse events in each treatment arm, both unrelated to the trial. Exercise rehabilitation was considered important by participants, and trial procedures, outcomes and interventions were acceptable. Conclusions The PULSE trial procedures and interventions were acceptable, and important design considerations were identified. A definitive RCT testing a remotely supervised exercise rehabilitation and behavioural/motivational support intervention for people with PoTS is feasible in the UK National Health Service.",

author = "Gordon McGregor and Becky Evans and Sandhu, {Harbinder Kaur} and Julie Bruce and Gita Devi and Hayat, {Sajad Ahmed} and Hee, {Siew Wan} and Peter Heine and Nikki Holliday and Shivam Joshi and Lesley Kavi and Boon Lim and Angela Noufaily and Nicholas Parsons and Shilpa Patel and Gemma Pearce and Richard Powell and Eva Schultz and Simmonds, {Jane V.} and Albiona Zhupaj and Helen Eftekhari and Sandeep Panikker",

note = "This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/ licenses/by/4.0/ Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group.",

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doi = "10.1136/bmjopen-2024-090197",

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T1 - Exercise rehabilitation for people with postural tachycardia syndrome at two secondary care centres in the UK

T2 - the PULSE feasibility randomised controlled trial

AU - McGregor, Gordon

AU - Evans, Becky

AU - Sandhu, Harbinder Kaur

AU - Bruce, Julie

AU - Devi, Gita

AU - Hayat, Sajad Ahmed

AU - Hee, Siew Wan

AU - Heine, Peter

AU - Holliday, Nikki

AU - Joshi, Shivam

AU - Kavi, Lesley

AU - Lim, Boon

AU - Noufaily, Angela

AU - Parsons, Nicholas

AU - Patel, Shilpa

AU - Pearce, Gemma

AU - Powell, Richard

AU - Schultz, Eva

AU - Simmonds, Jane V.

AU - Zhupaj, Albiona

AU - Eftekhari, Helen

AU - Panikker, Sandeep

N1 - This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/ licenses/by/4.0/ Publisher Copyright: © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group.

PY - 2025/2/22

Y1 - 2025/2/22

N2 - Objectives The aim of the study was to assess the feasibility of conducting a definitive multicentre randomised controlled trial (RCT) testing an online exercise rehabilitation and behavioural/motivational support intervention for people with postural tachycardia syndrome (PoTS). Design Feasibility RCT. Setting Two secondary care centres. Participants Adults aged 18 to 60 years with PoTS. Exclusions were serious mental health/cognitive problem preventing safe participation; currently undertaking physical activity equivalent to the Chief Medical Officer guidelines; pregnancy. Interventions Participants were randomly assigned (1:1) to best-practice usual care (a single 1:1 session of advice) or the ‘postural tachycardia syndrome exercise’ (PULSE) intervention: (1) individual online consultation, (2) 12 weeks of supervised online group exercise and behavioural/motivational support, and (3) home exercise programme with recumbent exercise bike. Outcomes The primary outcome was feasibility: (1) patients screened, eligible, recruited, randomised, withdrawn; (2) adherence; (3) physiological, clinical and patient-reported outcomes (4 and 7 months); and (4) embedded qualitative study to evaluate acceptability. Results 209 patients screened between 5 May 2021 and 1 December 2022, 44 (female 98%; age 29.9 SD, 7.5) were randomised to usual care (n=21) or PULSE (n=23) (71% of target). Follow-up at 4 months was n=12 and n=17 respectively (66% of target). Median live exercise/ support session attendance was 15 (IQR 12 to 17) of 18 sessions. Home exercise bike usage was highly variable. There were two serious adverse events in each treatment arm, both unrelated to the trial. Exercise rehabilitation was considered important by participants, and trial procedures, outcomes and interventions were acceptable. Conclusions The PULSE trial procedures and interventions were acceptable, and important design considerations were identified. A definitive RCT testing a remotely supervised exercise rehabilitation and behavioural/motivational support intervention for people with PoTS is feasible in the UK National Health Service.

AB - Objectives The aim of the study was to assess the feasibility of conducting a definitive multicentre randomised controlled trial (RCT) testing an online exercise rehabilitation and behavioural/motivational support intervention for people with postural tachycardia syndrome (PoTS). Design Feasibility RCT. Setting Two secondary care centres. Participants Adults aged 18 to 60 years with PoTS. Exclusions were serious mental health/cognitive problem preventing safe participation; currently undertaking physical activity equivalent to the Chief Medical Officer guidelines; pregnancy. Interventions Participants were randomly assigned (1:1) to best-practice usual care (a single 1:1 session of advice) or the ‘postural tachycardia syndrome exercise’ (PULSE) intervention: (1) individual online consultation, (2) 12 weeks of supervised online group exercise and behavioural/motivational support, and (3) home exercise programme with recumbent exercise bike. Outcomes The primary outcome was feasibility: (1) patients screened, eligible, recruited, randomised, withdrawn; (2) adherence; (3) physiological, clinical and patient-reported outcomes (4 and 7 months); and (4) embedded qualitative study to evaluate acceptability. Results 209 patients screened between 5 May 2021 and 1 December 2022, 44 (female 98%; age 29.9 SD, 7.5) were randomised to usual care (n=21) or PULSE (n=23) (71% of target). Follow-up at 4 months was n=12 and n=17 respectively (66% of target). Median live exercise/ support session attendance was 15 (IQR 12 to 17) of 18 sessions. Home exercise bike usage was highly variable. There were two serious adverse events in each treatment arm, both unrelated to the trial. Exercise rehabilitation was considered important by participants, and trial procedures, outcomes and interventions were acceptable. Conclusions The PULSE trial procedures and interventions were acceptable, and important design considerations were identified. A definitive RCT testing a remotely supervised exercise rehabilitation and behavioural/motivational support intervention for people with PoTS is feasible in the UK National Health Service.

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Exercise rehabilitation for people with postural tachycardia syndrome at two secondary care centres in the UK: the PULSE feasibility randomised controlled trial

Abstract

Bibliographical note

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Funding

UN SDGs

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