Evidence map›Paper›PMID 32429969›Full record

ArticleBMC pulmonary medicine2020

Supervised pulmonary hypertension exercise rehabilitation (SPHERe): study protocol for a multi-centre randomised controlled trial.

Gordon McGregor, Julie Bruce, Stuart Ennis, James Mason, Ranjit Lall, Chen Ji, Harbinder Sandhu, Kate Seers, Prithwish Banerjee, Alastair Canaway and 9 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC pulmonary medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
1.1field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Exercise-based rehabilitation programmes for pulmonary hypertension.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 7 institutions in 1 country.

Gordon McGregorDepartment of Cardiopulmonary Rehabilitation, Centre for Exercise & Health, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK. gordon.mcgregor@warwick.ac.uk.ORCID http://orcid.org/0000-0001-8963-9107
Julie BruceWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Stuart EnnisDepartment of Cardiopulmonary Rehabilitation, Centre for Exercise & Health, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK.
James MasonCentre for Health Economics at Warwick, Warwick Medical School, University of Warwick, Coventry, UK.
Ranjit LallWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Chen JiWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Harbinder SandhuWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Kate SeersWarwick Research in Nursing, Warwick Medical School, University of Warwick, Coventry, UK.
Prithwish BanerjeeWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Alastair CanawayWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Katie BoothWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Stephanie J C TaylorInstitute of Population Health Sciences, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Elizabeth RobertsonPatient & Public Involvement Representative, Leicester, UK.
Tamar PincusDepartment of Psychology, Royal Holloway University of London, London, UK.
Sally SinghCentre for Exercise and Rehabilitation Science, University Hospitals of Leicester NHS Trust, Leicester, UK.
David FitzmauriceWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Sarah BowaterDepartment of Cardiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Paul CliftDepartment of Cardiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Martin UnderwoodWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
University of Warwick · GBUniversity Hospitals Coventry and Warwickshire NHS Trust · GBUniversity Hospitals Birmingham NHS Foundation Trust · GBQueen Mary University of London · GBRoyal Holloway University of London · GBUniversity Hospitals of Leicester NHS Trust · GBUniversity of Leicester · GB

Funding

Department of Health 17/129/02Health Technology Assessment Programme 17/129/02
6 · The paper itself

Abstract

backgroundSupervised 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.

methodsThis 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.

trial registrationISRCTN no. 10608766, prospectively registered on 18th March 2019.

Indexed as

Cost-Benefit AnalysisExercise TherapyHumansHypertension, PulmonaryMulticenter Studies as TopicOutpatientsPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicState MedicineUnited KingdomWalk TestCardiac rehabilitationComplex interventionPulmonary hypertensionPulmonary rehabilitationRandomised controlled trial

Identifiers

PMID32429969
PMCPMC7236437
OpenAlexW3028135007

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.