Evidence map›Paper›PMID 39033102›Full record

ArticleTrials2024

Protocol update for a multi-centre randomised controlled trial of exercise rehabilitation for people with pulmonary hypertension: the SPHERe trial.

Stuart Ennis, Julie Bruce, Harbinder Sandhu, Mariam Ratna, Ranjit Lall, Chen Ji, James Mason, Rebecca Kandiyali, Kate Seers, Prithwish Banerjee and 4 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Selection and reporting of usual care comparators when designing primary care trials of complex health interventions: a systematic review.The British journal of general practice : the journal of the Royal College of General Practitioners · 2025
    Pooled it
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

14 authors.

Stuart EnnisWarwick Medical School, University of Warwick, Coventry, UK.
Julie BruceWarwick Medical School, University of Warwick, Coventry, UK.
Harbinder SandhuWarwick Medical School, University of Warwick, Coventry, UK.
Mariam RatnaWarwick Medical School, University of Warwick, Coventry, UK.
Ranjit LallWarwick Medical School, University of Warwick, Coventry, UK.
Chen JiWarwick Medical School, University of Warwick, Coventry, UK.
James MasonWarwick Medical School, University of Warwick, Coventry, UK.
Rebecca KandiyaliWarwick Medical School, University of Warwick, Coventry, UK.
Kate SeersWarwick Medical School, University of Warwick, Coventry, UK.
Prithwish BanerjeeWarwick 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, London, UK.
Martin UnderwoodWarwick Medical School, University of Warwick, Coventry, UK.
Gordon McGregorWarwick Medical School, University of Warwick, Coventry, UK. gordon.mcgregor@uhcw.nhs.uk.ORCID http://orcid.org/0000-0001-8963-9107

Funding

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

Abstract

backgroundThe SPHERe (Supervised Pulmonary Hypertension Exercise Rehabilitation) trial is a multi-centre, pragmatic, randomised controlled trial assessing the clinical and cost-effectiveness of supervised exercise rehabilitation with psychosocial and motivational support compared to best-practice usual care for people with pulmonary hypertension (PH). The original protocol was published in BMC Pulmonary Medicine (accessible online). We randomised our first participant in January 2020. In response to the COVID-19 pandemic, the trial was stopped in March 2020. In person delivery of the SPHERe intervention to a vulnerable population was not possible during the COVID-19 pandemic. We describe here how trial procedures and intervention delivery were adapted in response to the COVID-19 pandemic.

methodsRestrictions imposed by the COVID-19 pandemic on the clinically vulnerable PH population meant that trial delivery was changed from a centre-based rehabilitation programme to remotely delivered group online sessions. This led to minor alterations to the eligibility criteria. These changes followed a consultation process with stakeholders and people with PH and were approved by the funder and independent trial committees.

conclusionsWe describe the modified SPHERe trial protocol in response to restrictions imposed by the COVID-19 pandemic. SPHERe is the first randomised controlled trial to assess the clinical and cost-effectiveness of an online group rehabilitation programme for people with PH compared to usual care.

trial registrationISRCTN no. 10608766. Prospectively registered on 18th March 2019, updated 16th August 2023.

Indexed as

Cost-Benefit AnalysisCOVID-19Exercise TherapyHypertension, PulmonaryHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicSARS-CoV-2Treatment OutcomeCardiopulmonary rehabilitationComplex interventionOnline exercisePulmonary hypertension

Identifiers

PMID39033102
PMCPMC11264996

What OpenQuestion holds

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LicenceCC BY
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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 OpenQuestion graph.