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Supervised pulmonary hypertension exercise rehabilitation (SPHERe) : study protocol for a multi-centre randomised controlled trial
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McGregor, Gordon, Bruce, Julie, Ennis, Stuart, Mason, James, Lall, Ranjit, Ji, Chen, Sandhu, Harbinder, Seers, Kate, Banerjee, Prithwish, Canaway, Alastair, Booth, Katie, Taylor, Stephanie J. C., Robertson, Elizabeth, Pincus, Tamar, Singh, Sally, Fitzmaurice, David A., Bowater, Sarah, Clift, Paul and Underwood, Martin (2020) Supervised pulmonary hypertension exercise rehabilitation (SPHERe) : study protocol for a multi-centre randomised controlled trial. BMC Pulmonary Medicine, 20 (1). 143. doi:10.1186/s12890-020-01182-y
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WRAP-supervised-pulmonary-hypertension-exercise-rehabilitation-protocal-trial-McGregor-2020.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (894Kb) | Preview |
Official URL: http://dx.doi.org/10.1186/s12890-020-01182-y
Abstract
Background
Supervised cardio-pulmonary rehabilitation may be safe and beneficial for people with pulmonary hypertension (PH) in groups 1 (pulmonary arterial hypertension) and 4 (chronic thromboembolic disease), particularly as a hospital in-patient. It has not been tested in the most common PH groups; 2 (left heart disease), 3 (lung disease), or 5 (other disorders). Further it has not been evaluated in the UK National Health Service (NHS) out-patient setting, or with long-term follow-up. The aim of this randomised controlled trial (RCT) is to test the clinical and cost-effectiveness of a supervised exercise rehabilitation intervention with psychosocial support compared to best practice usual care for people with PH in the community/outpatient setting.
Methods
This multi-centre, pragmatic, two-arm RCT with embedded process evaluation aims to recruit 352 clinically stable adults with PH (groups 1–5) and WHO functional class II-IV. Participants will be randomised to either the Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention or control. The SPHERe intervention consists of 1) individual assessment and familiarisation sessions; 2) 8-week, twice-weekly, supervised out-patient exercise training; 3) psychosocial/motivational support and education; 4) guided home exercise plan. The control intervention consists of best practice usual care with a single one-to-one practitioner appointment, and general advice on physical activity. Outcomes will be measured at baseline, 4 months (post-intervention) and 12 months by researchers blinded to treatment allocation. The primary outcome is the incremental shuttle walk test at 4 months. Secondary outcomes include health-related quality of life (HRQoL), time to clinical worsening and health and social care use. A purposive sample of participants (n = 20 intervention and n = 20 control) and practitioners (n = 20) will be interviewed to explore experiences of the trial, outcomes and interventions.
Discussion
The SPHERe study is the first multi-centre clinical RCT to assess the clinical and cost effectiveness of a supervised exercise rehabilitation intervention compared to usual care, delivered in the UK NHS, for people in all PH groups. Results will inform clinicians and commissioners as to whether or not supervised exercise rehabilitation is effective and should be routinely provided for people with PH.
| Item Type: | Journal Article | |||||||||
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| Subjects: | R Medicine > RC Internal medicine | |||||||||
| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School Faculty of Medicine > Warwick Medical School > Health Sciences > Warwick Research in Nursing |
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| Library of Congress Subject Headings (LCSH): | Pulmonary hypertension -- Treatment, Heart -- Diseases -- Patients -- Rehabilitation, Respiratory therapy, Respiratory organs| -- Diseases -- Patients -- Rehabilitation, Clinical exercise physiology, Exercise -- Physiological aspects | |||||||||
| Journal or Publication Title: | BMC Pulmonary Medicine | |||||||||
| Publisher: | BioMed Central Ltd. | |||||||||
| ISSN: | 1471-2466 | |||||||||
| Official Date: | 19 May 2020 | |||||||||
| Dates: |
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| Date of first compliant deposit: | 28 May 2020 | |||||||||
| Volume: | 20 | |||||||||
| Number: | 1 | |||||||||
| Article Number: | 143 | |||||||||
| DOI: | 10.1186/s12890-020-01182-y | |||||||||
| Status: | Peer Reviewed | |||||||||
| Publication Status: | Published | |||||||||
| Access rights to Published version: | Open Access | |||||||||
| RIOXX Funder/Project Grant: |
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