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

Ennis, S and McGregor, G and Hamborg, T and Jones, H and Shave, R and Singh, SJ and Banerjee, P (2017) Randomised feasibility trial into the effects of low-frequency electrical muscle stimulation in advanced heart failure patients. BMJ Open, 7 (8). ISSN 2044-6055

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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.

Item Type: Article
Uncontrolled Keywords: advanced heart failure; cardiac rehabilitation; electrical muscle stimulation; feasibility; neuromuscular electrical stimulation
Subjects: Q Science > QP Physiology
R Medicine > RC Internal medicine > RC1200 Sports Medicine
Divisions: Sport & Exercise Sciences
Publisher: BMJ Publishing
Related URLs:
Date Deposited: 10 Oct 2017 14:39
Last Modified: 10 Oct 2017 14:39
DOI or Identification number: 10.1136/bmjopen-2017-016148
URI: http://researchonline.ljmu.ac.uk/id/eprint/7326

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