A future definitive trial is not feasible to assess the acceptability of neuromuscular electrical stimulation (NMES) of the quadriceps muscles in people with idiopathic pulmonary fibrosis (IPF), according to study results published in BMJ Open.
Neuromuscular electrical stimulation may be a potential treatment for muscle weakness in advanced progressive disease and could be considered a suitable home intervention for people with muscle weakness who have difficulty engaging with existing pulmonary rehabilitation services. There are no published studies exploring the role or effects of NMES in IPF to date. Therefore, researchers aimed to determine the acceptability of NMES of the quadriceps in 22 people with IPF and to identify whether a future definitive trial is feasible through a randomized, parallel, 2-group, participant and assessor-blinded, placebo-controlled feasibility trial with embedded qualitative interviews (ClinicalTrials.gov Identifier: NCT03499275).
The patients received usual care (home-based exercise, weekly telephone support, and breathlessness management leaflet) with either placebo or active NMES for 6 weeks, with follow-up at 6 and 12 weeks. 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. Secondary outcome measures were feasible with most missing data associated with the accelerometer. However, 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.
“We conclude that a definitive clinical trial to investigate the efficacy of NMES of the quadriceps muscles in advanced IPF using this protocol is not feasible,” the authors stated. “However, novel findings such as the frequency of telephone support, exercise and NMES diary format and choice of support and monitoring platform, for example, online versus telephone, could inform trials of future home rehabilitation interventions in this population.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Nolan CM, Patel S, Barker RE, et al. Muscle stimulation in advanced idiopathic pulmonary fibrosis: a randomised placebo-controlled feasibility study. BMJ Open. 2021;11:e048808. doi:10.1136/bmjopen-2021-048808