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  4. Muscle stimulation in advanced idiopathic pulmonary fibrosis: a randomised placebo-controlled feasibility study.
 
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Muscle stimulation in advanced idiopathic pulmonary fibrosis: a randomised placebo-controlled feasibility study.
File(s)
Muscle stimulation in advanced idiopathic pulmonary fibrosis a randomised placebo-controlled feasibility study.pdf (895.23 KB)
Accepted version
Author(s)
Nolan, Claire M
Patel, Suhani
Barker, Ruth E
Walsh, Jessica A
Polgar, Oliver
more
Type
Journal Article
Abstract
OBJECTIVES: To 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. DESIGN: A randomised, parallel, two-group, participant and assessor-blinded, placebo-controlled feasibility trial with embedded qualitative interviews. SETTING: Outpatient department, Royal Brompton and Harefield Hospitals. PARTICIPANTS: Twenty-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. INTERVENTIONS: Usual 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. RESULTS: Out of 364 people screened, 23 were recruited: 11 were allocated to each group and one was withdrawn prior to randomisation.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. CONCLUSIONS: Primarily 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.
Date Issued
2021-06-02
Date Acceptance
2021-05-19
Citation
BMJ Open, 2021, 11 (6), pp.1-11
URI
http://hdl.handle.net/10044/1/90345
URL
https://bmjopen.bmj.com/content/11/6/e048808
DOI
https://www.dx.doi.org/10.1136/bmjopen-2021-048808
ISSN
2044-6055
Publisher
BMJ Journals
Start Page
1
End Page
11
Journal / Book Title
BMJ Open
Volume
11
Issue
6
Copyright Statement
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
License URL
http://creativecommons.org/licenses/by-nc/4.0/
Sponsor
National Institute for Health Research
British Lung Foundation
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/34083348
PII: bmjopen-2021-048808
Grant Number
CS-2013-13-017
C17-3
Subjects
interstitial lung disease
rehabilitation medicine
respiratory medicine (see thoracic medicine)
Aged
Double-Blind Method
Feasibility Studies
Humans
Idiopathic Pulmonary Fibrosis
Quadriceps Muscle
Walk Test
Publication Status
Published
Coverage Spatial
England
Date Publish Online
2021-06-02
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