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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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Official URL: http://dx.doi.org/10.1186/s12890-020-01182-y

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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
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
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:
DateEvent
19 May 2020Published
11 May 2020Accepted
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:
Project/Grant IDRIOXX Funder NameFunder ID
17/129/02[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
UNSPECIFIEDNational Institute for Health Research. Collaboration for Leadership in Applied Health Research North Thames at Bart’s Health NHS TrustUNSPECIFIED

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