Evidence map›Paper›PMID 34083348›Full record

Trial reportBMJ open2021

Muscle stimulation in advanced idiopathic pulmonary fibrosis: a randomised placebo-controlled feasibility study.

Claire M Nolan, Suhani Patel, Ruth E Barker, Jessica A Walsh, Oliver Polgar, Matthew Maddocks, Peter M George, Elisabetta A Renzoni, Athol U Wells, Philip L Molyneaux and 4 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03499275 (MUscle STimulation in Advanced Idiopathic Pulmonary Fibrosis), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 12% 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.

NCT03499275 nacompletednot on this map

MUscle STimulation in Advanced Idiopathic Pulmonary Fibrosis: a Randomised Placebo-controlled Trial

TypeinterventionalSponsorRoyal Brompton & Harefield NHS Foundation TrustRan2018 to 2020Enrolled23ConditionsIdiopathic Pulmonary FibrosisArmsActive NMES, Sham NMES, Home exercise programme, Breathlessness advice
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Physical activity measurements in individuals with interstitial lung disease: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2023
    Pooled it
  2. Article
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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 at 4 institutions in 2 countries.

Claire M NolanHarefield Respiratory Research Group, Royal Brompton and Harefield Clinical Group, Guy's and St Thomas' Hospitals NHS Trust, London, UK c.nolan@rbht.nhs.uk.ORCID 0000-0001-9067-599X
Suhani PatelHarefield Respiratory Research Group, Royal Brompton and Harefield Clinical Group, Guy's and St Thomas' Hospitals NHS Trust, London, UK.
Ruth E BarkerHarefield Respiratory Research Group, Royal Brompton and Harefield Clinical Group, Guy's and St Thomas' Hospitals NHS Trust, London, UK.
Jessica A WalshHarefield Respiratory Research Group, Royal Brompton and Harefield Clinical Group, Guy's and St Thomas' Hospitals NHS Trust, London, UK.
Oliver PolgarHarefield Respiratory Research Group, Royal Brompton and Harefield Clinical Group, Guy's and St Thomas' Hospitals NHS Trust, London, UK.
Matthew MaddocksCicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, UK.
Peter M GeorgeNational Heart and Lung Institute, Imperial College London, London, UK.
Elisabetta A RenzoniNational Heart and Lung Institute, Imperial College London, London, UK.
Athol U WellsNational Heart and Lung Institute, Imperial College London, London, UK.
Philip L MolyneauxNational Heart and Lung Institute, Imperial College London, London, UK.
Vasilis KouranosNational Heart and Lung Institute, Imperial College London, London, UK.
Felix ChuaNational Heart and Lung Institute, Imperial College London, London, UK.
Toby M MaherNational Heart and Lung Institute, Imperial College London, London, UK.
William D-C ManHarefield Respiratory Research Group, Royal Brompton and Harefield Clinical Group, Guy's and St Thomas' Hospitals NHS Trust, London, UK.
Guy's and St Thomas' NHS Foundation Trust · GBSt Thomas' Hospital · GBKing's College London · GBUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the acceptability of neuromuscular electrical stimulation (NMES) of the quadriceps muscles in people with idiopathic pulmonary fibrosis (IPF) and to identify whether a future definitive trial is feasible.

designA randomised, parallel, two-group, participant and assessor-blinded, placebo-controlled feasibility trial with embedded qualitative interviews.

settingOutpatient department, Royal Brompton and Harefield Hospitals.

participantsTwenty-two people with IPF: median (25th, 75th centiles) age 76 (74, 82) years, forced vital capacity 62 (50, 75) % predicted, 6 min walk test distance 289 (149, 360) m.

interventionsUsual care (home-based exercise, weekly telephone support, breathlessness management leaflet) with either placebo or active NMES for 6 weeks, with follow-up at 6 and 12 weeks. PRIMARY OUTCOME MEASURES: Feasibility of recruitment and retention, treatment uptake and adherence, outcome assessments, participant and outcome assessor blinding and adverse events related to interventions. SECONDARY OUTCOME MEASURES: Outcome measures with potential to be primary or secondary outcomes in a definitive clinical trial. In addition, purposively sampled participants were interviewed to capture their experiences and acceptability of the trial.

resultsOut of 364 people screened, 23 were recruited: 11 were allocated to each group and one was withdrawn prior to randomisation. Compared with the control group, a greater proportion of the intervention group completed the intervention, remained in the trial blinded to group allocation and experienced intervention-related adverse events. Assessor blinding was maintained. The secondary outcome measures were feasible with most missing data associated with the accelerometer. Small participant numbers precluded identification of an outcome measure suitable for a definitive trial. Qualitative findings demonstrated that trial process and active NMES were acceptable but there were concerns about the credibility of placebo NMES.

conclusionsPrimarily owing to recruitment difficulties, a definitive trial using the current protocol to evaluate NMES in people with IPF is not feasible. TRIAL REGISTRATION NUMBER: NCT03499275.

Indexed as

Idiopathic Pulmonary FibrosisQuadriceps MuscleAgedDouble-Blind MethodFeasibility StudiesHumansWalk Testinterstitial lung diseaserehabilitation medicinerespiratory medicine (see thoracic medicine)

Identifiers

PMID34083348
PMCPMC8174518
OpenAlexW3165334116

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.