Exercise rehabilitation for people with postural tachycardia syndrome at two secondary care centres in the UK: the PULSE feasibility randomised controlled trial
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 R...
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BMJ Publishing Group
2025-02-01
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| author | Gordon McGregor Richard Powell Gemma Pearce Nicholas Parsons Peter Heine Julie Bruce Albiona Zhupaj Sandeep Panikker Sajad Hayat Harbinder Kaur Sandhu Shivam Joshi Shilpa Patel Nikki Holliday Siew Wan Hee Jane Simmonds Lesley Kavi Angela Noufaily Helen Eftekhari Becky Evans Gita Devi Lim Boon Eva Schultz |
| author_facet | Gordon McGregor Richard Powell Gemma Pearce Nicholas Parsons Peter Heine Julie Bruce Albiona Zhupaj Sandeep Panikker Sajad Hayat Harbinder Kaur Sandhu Shivam Joshi Shilpa Patel Nikki Holliday Siew Wan Hee Jane Simmonds Lesley Kavi Angela Noufaily Helen Eftekhari Becky Evans Gita Devi Lim Boon Eva Schultz |
| author_sort | Gordon McGregor |
| collection | DOAJ |
| description | 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exercise bike.Outcomes The primary outcome was feasibility: (1) patients screened, eligible, recruited, randomised, withdrawn; (2) adherence; (3) physiological, clinical and patient-reported outcomes (4 and 7 months); and (4) embedded qualitative study to evaluate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.Trial registration number ISRCTN45323485. |
| format | Article |
| id | doaj-art-96b99922a04d4ca6b71e1b05db27e5f6 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-02-01 |
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| spelling | doaj-art-96b99922a04d4ca6b71e1b05db27e5f62025-08-20T03:13:10ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115210.1136/bmjopen-2024-090197Exercise rehabilitation for people with postural tachycardia syndrome at two secondary care centres in the UK: the PULSE feasibility randomised controlled trialGordon McGregor0Richard Powell1Gemma Pearce2Nicholas Parsons3Peter Heine4Julie Bruce5Albiona Zhupaj6Sandeep Panikker7Sajad Hayat8Harbinder Kaur Sandhu9Shivam Joshi10Shilpa Patel11Nikki Holliday12Siew Wan Hee13Jane Simmonds14Lesley Kavi15Angela Noufaily16Helen Eftekhari17Becky Evans18Gita Devi19Lim Boon20Eva Schultz211 Coventry University, Coventry, UKDepartment of Cardiac Rehabilitation, Centre for Exercise & Health, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UKDepartment of Psychology and Behavioural Sciences, Coventry University, Coventry, UKWarwick Medical School, University of Warwick, Coventry, UK3 University of Warwick, Coventry, UKWarwick Clinical Trials Unit, University of Warwick, Coventry, UK1University Hospital Coventry and Warwickshire NHS Trust1University Hospitals Coventry and Warwickshire, Clifford Bridge Road, Coventry, WAR CV2 2DX, UKDepartment of Cardiology, University Hospital Coventry, Coventry, UK3 University of Warwick, Coventry, UK2 Internal Medicine, New York University, New York, New York, USAWMS, Clinical Trials Unit, University of Warwick, Coventry, UKBirmingham and Solihull Mental Health Trust, University of Birmingham, Coventry University, University of NottinghamWarwick Medical School, University of Warwick, Coventry, UK7 University College London, London, UKPoTs UK, www.potsuk.orgWarwick Medical School, Coventry, UKCardiology Department, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK2 University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK1 Coventry University, Coventry, UK6 Imperial College Healthcare NHS Trust, London, UK1 Coventry University, Coventry, UKObjectives 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.Trial registration number ISRCTN45323485.https://bmjopen.bmj.com/content/15/2/e090197.full |
| spellingShingle | Gordon McGregor Richard Powell Gemma Pearce Nicholas Parsons Peter Heine Julie Bruce Albiona Zhupaj Sandeep Panikker Sajad Hayat Harbinder Kaur Sandhu Shivam Joshi Shilpa Patel Nikki Holliday Siew Wan Hee Jane Simmonds Lesley Kavi Angela Noufaily Helen Eftekhari Becky Evans Gita Devi Lim Boon Eva Schultz Exercise rehabilitation for people with postural tachycardia syndrome at two secondary care centres in the UK: the PULSE feasibility randomised controlled trial BMJ Open |
| title | Exercise rehabilitation for people with postural tachycardia syndrome at two secondary care centres in the UK: the PULSE feasibility randomised controlled trial |
| title_full | Exercise rehabilitation for people with postural tachycardia syndrome at two secondary care centres in the UK: the PULSE feasibility randomised controlled trial |
| title_fullStr | Exercise rehabilitation for people with postural tachycardia syndrome at two secondary care centres in the UK: the PULSE feasibility randomised controlled trial |
| title_full_unstemmed | Exercise rehabilitation for people with postural tachycardia syndrome at two secondary care centres in the UK: the PULSE feasibility randomised controlled trial |
| title_short | Exercise rehabilitation for people with postural tachycardia syndrome at two secondary care centres in the UK: the PULSE feasibility randomised controlled trial |
| title_sort | exercise rehabilitation for people with postural tachycardia syndrome at two secondary care centres in the uk the pulse feasibility randomised controlled trial |
| url | https://bmjopen.bmj.com/content/15/2/e090197.full |
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