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Sports and exercise medicine
Research
Randomised feasibility trial into the effects of low-frequency electrical muscle stimulation in advanced heart failure patients
  1. Stuart Ennis1,2,
  2. Gordon McGregor1,3,
  3. Thomas Hamborg4,
  4. Helen Jones5,
  5. Robert Shave2,
  6. Sally J Singh3,6,
  7. Prithwish Banerjee1,3
  1. 1 Department of Cardiac Rehabilitation, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK
  2. 2 School of Sport, Cardiff Metropolitan University, Cardiff, UK
  3. 3 Centre for Applied Biological and Exercise Sciences & Centre for Technology Enabled Health Research, University of Coventry, Coventry, UK
  4. 4 Clinical Trials Unit, University of Warwick, Coventry, UK
  5. 5 Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK
  6. 6 Centre for Exercise and Rehabilitation Science, University Hospitals of Leicester NHS trust, Leicester, UK
  1. Correspondence to Stuart Ennis; stuart.ennis{at}uhcw.nhs.uk

Abstract

Objectives Low-frequency electrical muscle stimulation (LF-EMS) may have the potential to reduce breathlessness and increase exercise capacity in the chronic heart failure population who struggle to adhere to conventional exercise. The study’s aim was to establish if a randomised controlled trial of LF-EMS was feasible.

Design and setting Double blind (participants, outcome assessors), randomised study in a secondary care outpatient cardiac rehabilitation programme.

Participants Patients with severe heart failure (New York Heart Association class III–IV) having left ventricular ejection fraction <40% documented by echocardiography were eligible.

Interventions Participants were randomised (remotely by computer) to 8 weeks (5×60 mins per week) of either LF-EMS intervention (4 Hz, continuous, n=30) or sham placebo (skin level stimulation only, n=30) of the quadriceps and hamstrings muscles. Participants used the LF-EMS straps at home and were supervised weekly

Outcome measures Recruitment, adherence and tolerability to the intervention were measured during the trial as well as physiological outcomes (primary outcome: 6 min walk, secondary outcomes: quadriceps strength, quality of life and physical activity).

Results Sixty of 171 eligible participants (35.08%) were recruited to the trial. 12 (20%) of the 60 patients (4 LF-EMS and 8 sham) withdrew. Forty-one patients (68.3%), adhered to the protocol for at least 70% of the sessions. The physiological measures indicated no significant differences between groups in 6 min walk distance(p=0.13) and quality of life (p=0.55) although both outcomes improved more with LF-EMS.

Conclusion Patients with severe heart failure can be recruited to and tolerate LF-EMS studies. A larger randomised controlled trial (RCT) in the advanced heart failure population is technically feasible, although adherence to follow-up would be challenging. The preliminary improvements in exercise capacity and quality of life were minimal and this should be considered if planning a larger trial.

Trial registration number ISRCTN16749049

  • advanced heart failure
  • electrical muscle stimulation
  • neuromuscular electrical stimulation
  • cardiac rehabilitation
  • feasibility

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2017-016148

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    Footnotes

    • Contributors SE, GM and PB: contributed to the conception of the work. SE, GM, PB, SS, HJ, RS and TH: contributed to the design of the work. SE and GM: contributed to the acquisition, of the work. SE, GM, PB, SJS, HJ, RS and TH: contributed to the, analysis, or interpretation of data for the work. SE and GM: drafted the manuscript. PB, SJS, HJ, RS and TH: critically revised the manuscript. All authors: gave final approval and agree to be accountable for all aspects of work ensuring integrity and accuracy.

    • Funding This study was funded by a National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) award.

    • Disclaimer This article/paper/report presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

    • Competing interests None declared.

    • Patient consent no identifiable patient information is contained within the submitted manuscript.

    • Ethics approval NRES Committee West Midlands - Coventry & Warwickshire13/WM/0240.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement All available data can be obtained by contacting the corresponding author: stuart.ennis@uhcw.nhs.uk.