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

Stuart Ennis, Gordon McGregor, Thomas Hamborg, Helen Jones, Robert Shave, Sally J Singh, Prithwish Banerjee, Stuart Ennis, Gordon McGregor, Thomas Hamborg, Helen Jones, Robert Shave, Sally J Singh, Prithwish Banerjee

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.

Keywords: advanced heart failure; cardiac rehabilitation; electrical muscle stimulation; feasibility; neuromuscular electrical stimulation.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Flow diagram of a single-centre blinded parallel group randomised feasibility trial of EMS versus sham placebo in patients with severe heart failure. LF-EMS, low-frequency electrical muscle stimulation.

References

    1. Ambrosy AP, Fonarow GC, Butler J, et al. . The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol 2014;63:1123–33. 10.1016/j.jacc.2013.11.053
    1. NICE. 2010 guideline:cg108 chronic heart failure. 2010. (accessed Jan 2016).
    1. Kop WJ, Synowski SJ, Gottlieb SS. Depression in heart failure: biobehavioral mechanisms. Heart Fail Clin 2011;7:23–38. 10.1016/j.hfc.2010.08.011
    1. Taylor RS, Sagar VA, Davies EJ, et al. . Exercise-based rehabilitation for heart failure. Cochrane Database Syst Rev 2014;4:CD003331.
    1. Piepoli MF, Conraads V, Corrà U, et al. . Exercise training in heart failure: from theory to practice. a consensus document of the Heart Failure Association and the European Association for Cardiovascular Prevention and Rehabilitation. Eur J Heart Fail 2011;13:347–57. 10.1093/eurjhf/hfr017
    1. Höllriegel R, Winzer EB, Linke A, et al. . Long-Term Exercise Training in Patients With Advanced Chronic Heart Failure: sustained benefits on left ventricular performance and exercise capacity. J Cardiopulm Rehabil Prev 2016;36:117–24. 10.1097/HCR.0000000000000165
    1. Piepoli MF, Davos C, Francis DP, et al. . Exercise training meta-analysis of trials in patients with chronic heart failure (ExTraMATCH). BMJ 2004;1328:189.
    1. Sallach JA, Goldstein S. Use of beta-blockers in congestive heart failure. Ann Med 2003;35:259–66. 10.1080/14734220310011716
    1. Flather MD, Yusuf S, Køber L, et al. . Long-term ACE-inhibitor therapy in patients with heart failure or left-ventricular dysfunction: a systematic overview of data from individual patients. The Lancet 2000;355:1575–81. 10.1016/S0140-6736(00)02212-1
    1. Smart NA, Dieberg G, Giallauria F. Functional electrical stimulation for chronic heart failure: a meta-analysis. Int J Cardiol 2013;167:80–6. 10.1016/j.ijcard.2011.12.019
    1. Nuhr MJ, Pette D, Berger R, et al. . Beneficial effects of chronic low-frequency stimulation of thigh muscles in patients with advanced chronic heart failure. Eur Heart J 2004;25:136–43. 10.1016/j.ehj.2003.09.027
    1. Dobsák P, Nováková M, Siegelová J, et al. . Low-frequency electrical stimulation increases muscle strength and improves blood supply in patients with chronic heart failure. Circ J 2006;70:75–82. 10.1253/circj.70.75
    1. Crognale D, Vito GD, Grosset JF, et al. . Neuromuscular electrical stimulation can elicit aerobic exercise response without undue discomfort in healthy physically active adults. J Strength Cond Res 2013. 2013;27:208–15. 10.1519/JSC.0b013e318252f5e5
    1. Minogue CM, Caulfield BM, Lowery MM. Whole body oxygen uptake and evoked torque during subtetanic isometric electrical stimulation of the quadriceps muscles in a single 30-minute session. Arch Phys Med Rehabil 2014;95:1750–8. 10.1016/j.apmr.2014.04.004
    1. Banerjee P, Clark A, Witte K, et al. . Electrical stimulation of unloaded muscles causes cardiovascular exercise by increasing oxygen demand. Eur J Cardiovasc Prev Rehabil 2005;12:503–8. 10.1097/01.hjr.0000169188.84184.23
    1. Banerjee P, Caulfield B, Crowe L, et al. . Prolonged electrical muscle stimulation exercise improves strength, peak VO2, and exercise capacity in patients with stable chronic heart failure. J Card Fail 2009;15:319–26. 10.1016/j.cardfail.2008.11.005
    1. Nieminen MS, Dickstein K, Fonseca C, et al. . The patient perspective: quality of life in advanced heart failure with frequent hospitalisations. Int J Cardiol 2015;191:256–64. 10.1016/j.ijcard.2015.04.235
    1. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract 2004;10:307–12. 10.1111/j.2002.384.doc.x
    1. Thabane L, Ma J, Chu R, et al. . A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol 2010;10:1 10.1186/1471-2288-10-1
    1. Holland AE, Spruit MA, Troosters T, et al. . An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J 2014;44:1428–46. 10.1183/09031936.00150314
    1. Schaubert KL, Bohannon RW. Reliability and validity of three strength measures obtained from community-dwelling elderly persons. J Strength Cond Res 2005;19:717–20. 10.1519/R-15954.1
    1. Rector TS, Cohn JN. Assessment of patient outcome with the Minnesota living with Heart failure questionnaire: reliability and validity during a randomized, double-blind, placebo-controlled trial of pimobendan. Pimobendan Multicenter Research Group. Am Heart J 1992;124:1017–25. 10.1016/0002-8703(92)90986-6
    1. Likert R. A technique for the measurement of attitudes. New York: The Science Press, 1932.
    1. Alshurafa M, Briel M, Akl EA, et al. . Inconsistent definitions for intention-to-treat in relation to missing outcome data: systematic review of the methods literature. PLoS One 2012;7:e49163 10.1371/journal.pone.0049163
    1. Täger T, Hanholz W, Cebola R, et al. . Minimal important difference for 6-minute walk test distances among patients with chronic heart failure. Int J Cardiol 2014;176:94–8. 10.1016/j.ijcard.2014.06.035
    1. The National Audit of Cardiac Rehabilitation. 2007. Annual Statistical Report 2015-2016. .
    1. O'Connor CM, Whellan DJ, Lee KL, et al. . Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA 2009;301:1439–50. 10.1001/jama.2009.454
    1. Vivodtzev I, Rivard B, Gagnon P, et al. . Tolerance and physiological correlates of neuromuscular electrical stimulation in COPD: a pilot study. PLoS One 2014;9:e94850 10.1371/journal.pone.0094850
    1. Reeves GR, Whellan DJ, O'Connor CM, et al. . A novel rehabilitation intervention for older patients with acute decompensated. JACC Heart Fail 2017;613:359–66.
    1. Guazzi M, Dickstein K, Vicenzi R, et al. . Six-minute walk test and cardiopulmonary exercise testing in patients with chronic heart failure. Circ Heart Fail 2009;2:549–55.
    1. Arslan S, Erol MK, Gundogdu F, et al. . Prognostic value of 6-minute walk test in stable outpatients with heart failure. Tex Heart Inst J 2007;34:166–9.
    1. Rostagno C, Olivo G, Comeglio M, et al. . Prognostic value of 6-minute walk corridor test in patients with mild to moderate heart failure: comparison with other methods of functional evaluation. Eur J Heart Fail 2003;5:247–52. 10.1016/S1388-9842(02)00244-1
    1. Zugck C, Krüger C, Dürr S, et al. . Is the 6-minute walk test a reliable substitute for peak oxygen uptake in patients with dilated cardiomyopathy? Eur Heart J 2000;21:540–9. 10.1053/euhj.1999.1861
    1. Jeon YH, Kraus SG, Jowsey T, et al. . The experience of living with chronic heart failure: a narrative review of qualitative studies. BMC Health Serv Res 2010;10:77 10.1186/1472-6963-10-77
    1. Quittan M, Wiesinger GF, Sturm B, et al. . Improvement of thigh muscles by neuromuscular electrical stimulation in patients with refractory heart failure: a single-blind, randomized, controlled trial. Am J Phys Med Rehabil 2001;80:206–14.
    1. Harris S, LeMaitre JP, Mackenzie G, et al. . A randomised study of home-based electrical stimulation of the legs and conventional bicycle exercise training for patients with chronic heart failure. Eur Heart J 2003;24:871–8. 10.1016/S0195-668X(02)00822-9
    1. Fülster S, Tacke M, Sandek A, et al. . Muscle wasting in patients with chronic heart failure: results from the studies investigating co-morbidities aggravating heart failure (SICA-HF). Eur Heart J 2013;34:512–9. 10.1093/eurheartj/ehs381
    1. Rullman E, Andersson DC, Melin M, et al. . Modifications of skeletal muscle ryanodine receptor type 1 and exercise intolerance in heart failure. J Heart Lung Transplant 2013;32:925–9. 10.1016/j.healun.2013.06.026

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