Randomised feasibility trial into the effects of low-frequency electrical muscle stimulation in advanced heart failure patients

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Author
Ennis, Stuart
McGregor, Gordon
Hamborg, Thomas
Jones, Helen
Shave, Rob
Singh, Sally
Banerjee, Prithwish
Date
2017-08-11Acceptance date
2017-07-07
Type
Article
Publisher
BMJ Open
ISSN
2044-6055 (ESSN)
Metadata
Show full item recordAbstract
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
Journal/conference proceeding
BMJ Open
Citation
Ennis S., McGregor G., Hamborg T., Jones, H., Shave, R., Singh, S. and Banerjee, P. (2017) 'Randomised feasibility trial into the effects of low-frequency electrical muscle stimulation in advanced heart failure patients' BMJ Open 7:e016148
Description
This article was published open access in BMJ Open on 11 August 2017 (online), available at http://dx.doi.org/10.1080/17511321.2017.1351484
Sponsorship
Cardiff Metropolitan University (Grant ID: Cardiff Metropolian (Internal))
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