Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study
Abstract Background Postural orthostatic tachycardia syndrome (POTS) is an autonomic nervous system disorder causing an abnormal cardiovascular response to upright posture. It affects around 0.2% of the population, most commonly women aged 13 to 50 years. POTS can be debilitating; prolonged episodes...
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BMC
2020-10-01
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Series: | Pilot and Feasibility Studies |
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Online Access: | http://link.springer.com/article/10.1186/s40814-020-00702-1 |
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doaj-c951b4ff6600459cb5ebf56458fbabc5 |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Gordon McGregor Siew Wan Hee Helen Eftekhari Nikki Holliday Gemma Pearce Harbinder Sandhu Jane Simmonds Shivam Joshi Lesley Kavi Julie Bruce Sandeep Panikker Boon Lim Sajad Hayat |
spellingShingle |
Gordon McGregor Siew Wan Hee Helen Eftekhari Nikki Holliday Gemma Pearce Harbinder Sandhu Jane Simmonds Shivam Joshi Lesley Kavi Julie Bruce Sandeep Panikker Boon Lim Sajad Hayat Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study Pilot and Feasibility Studies Postural orthostatic tachycardia syndrome Exercise Rehabilitation Dysautonomia Cardiac rehabilitation Randomised controlled trial |
author_facet |
Gordon McGregor Siew Wan Hee Helen Eftekhari Nikki Holliday Gemma Pearce Harbinder Sandhu Jane Simmonds Shivam Joshi Lesley Kavi Julie Bruce Sandeep Panikker Boon Lim Sajad Hayat |
author_sort |
Gordon McGregor |
title |
Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study |
title_short |
Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study |
title_full |
Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study |
title_fullStr |
Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study |
title_full_unstemmed |
Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study |
title_sort |
protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the pulse study |
publisher |
BMC |
series |
Pilot and Feasibility Studies |
issn |
2055-5784 |
publishDate |
2020-10-01 |
description |
Abstract Background Postural orthostatic tachycardia syndrome (POTS) is an autonomic nervous system disorder causing an abnormal cardiovascular response to upright posture. It affects around 0.2% of the population, most commonly women aged 13 to 50 years. POTS can be debilitating; prolonged episodes of pre-syncope and fatigue can severely affect activities of daily living and health-related quality of life (HRQoL). Medical treatment is limited and not supported by randomised controlled trial (RCT) evidence. Lifestyle interventions are first-line treatment, including increased fluid and salt intake, compression tights and isometric counter-pressure manoeuvres to prevent fainting. Observational studies and small RCTs suggest exercise training may improve symptoms and HRQoL in POTS, but evidence quality is low. Methods Sixty-two people (aged 18–40 years) with a confirmed diagnosis of POTS will be invited to enrol on a feasibility RCT with embedded qualitative study. The primary outcome will be feasibility; process-related measures will include the number of people eligible, recruited, randomised and withdrawn, along with indicators of exercise programme adherence and acceptability. Secondary physiological, clinical and health-related outcomes including sub-maximal recumbent bike exercise test, active stand test and HRQoL will be measured at 4 and 7 months post-randomisation by researchers blinded to treatment allocation. The PostUraL tachycardia Syndrome Exercise (PULSE) intervention consists of (1) individual assessment; (2) 12-week, once to twice-weekly, supervised out-patient exercise training; (3) behavioural and motivational support; and (4) guided lifestyle physical activity. The control intervention will be best-practice usual care with a single 30-min, one-to-one practitioner appointment, and general advice on safe and effective physical activity. For the embedded qualitative study, participants (n = 10 intervention, n = 10 control) will be interviewed at baseline and 4 months post-randomisation to assess acceptability and the feasibility of progressing to a definitive trial. Discussion There is very little high-quality research investigating exercise rehabilitation for people with POTS. The PULSE study will be the first randomised trial to assess the feasibility of conducting a definitive multicentre RCT testing supervised 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. |
topic |
Postural orthostatic tachycardia syndrome Exercise Rehabilitation Dysautonomia Cardiac rehabilitation Randomised controlled trial |
url |
http://link.springer.com/article/10.1186/s40814-020-00702-1 |
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doaj-c951b4ff6600459cb5ebf56458fbabc52020-11-25T03:40:11ZengBMCPilot and Feasibility Studies2055-57842020-10-016111110.1186/s40814-020-00702-1Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE studyGordon McGregor0Siew Wan Hee1Helen Eftekhari2Nikki Holliday3Gemma Pearce4Harbinder Sandhu5Jane Simmonds6Shivam Joshi7Lesley Kavi8Julie Bruce9Sandeep Panikker10Boon Lim11Sajad Hayat12Department of Cardiopulmonary Rehabilitation, Centre for Exercise & Health, University Hospitals Coventry & Warwickshire NHS TrustDivision of Health Sciences, Warwick Medical School, University of WarwickDepartment of Cardiology, University Hospitals Coventry & Warwickshire NHS TrustCentre for Sport, Exercise and Life Sciences, Coventry UniversityCentre for Sport, Exercise and Life Sciences, Coventry UniversityWarwick Clinical Trials Unit, Warwick Medical School, University of WarwickUCL Great Ormond Street Institute of Child Health, Faculty of Population Health, University College LondonResearch & Development, University Hospitals Coventry & Warwickshire NHS TrustPOTS UKWarwick Clinical Trials Unit, Warwick Medical School, University of WarwickDepartment of Cardiology, University Hospitals Coventry & Warwickshire NHS TrustDepartment of Cardiology, Imperial College Healthcare NHS TrustDepartment of Cardiology, Hamad Medical CorporationAbstract Background Postural orthostatic tachycardia syndrome (POTS) is an autonomic nervous system disorder causing an abnormal cardiovascular response to upright posture. It affects around 0.2% of the population, most commonly women aged 13 to 50 years. POTS can be debilitating; prolonged episodes of pre-syncope and fatigue can severely affect activities of daily living and health-related quality of life (HRQoL). Medical treatment is limited and not supported by randomised controlled trial (RCT) evidence. Lifestyle interventions are first-line treatment, including increased fluid and salt intake, compression tights and isometric counter-pressure manoeuvres to prevent fainting. Observational studies and small RCTs suggest exercise training may improve symptoms and HRQoL in POTS, but evidence quality is low. Methods Sixty-two people (aged 18–40 years) with a confirmed diagnosis of POTS will be invited to enrol on a feasibility RCT with embedded qualitative study. The primary outcome will be feasibility; process-related measures will include the number of people eligible, recruited, randomised and withdrawn, along with indicators of exercise programme adherence and acceptability. Secondary physiological, clinical and health-related outcomes including sub-maximal recumbent bike exercise test, active stand test and HRQoL will be measured at 4 and 7 months post-randomisation by researchers blinded to treatment allocation. The PostUraL tachycardia Syndrome Exercise (PULSE) intervention consists of (1) individual assessment; (2) 12-week, once to twice-weekly, supervised out-patient exercise training; (3) behavioural and motivational support; and (4) guided lifestyle physical activity. The control intervention will be best-practice usual care with a single 30-min, one-to-one practitioner appointment, and general advice on safe and effective physical activity. For the embedded qualitative study, participants (n = 10 intervention, n = 10 control) will be interviewed at baseline and 4 months post-randomisation to assess acceptability and the feasibility of progressing to a definitive trial. Discussion There is very little high-quality research investigating exercise rehabilitation for people with POTS. The PULSE study will be the first randomised trial to assess the feasibility of conducting a definitive multicentre RCT testing supervised 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.http://link.springer.com/article/10.1186/s40814-020-00702-1Postural orthostatic tachycardia syndromeExerciseRehabilitationDysautonomiaCardiac rehabilitationRandomised controlled trial |