Efficacy and Safety of Acute Phase Intensive Electrical Muscle Stimulation in Frail Older Patients with Acute Heart Failure: Results from the ACTIVE-EMS Trial

Shinya Tanaka, Kentaro Kamiya, Yuya Matsue, Ryusuke Yonezawa, Hiroshi Saito, Nobuaki Hamazaki, Ryota Matsuzawa, Kohei Nozaki, Masashi Yamashita, Kazuki Wakaume, Yoshiko Endo, Emi Maekawa, Minako Yamaoka-Tojo, Takaaki Shiono, Takayuki Inomata, Junya Ako, Shinya Tanaka, Kentaro Kamiya, Yuya Matsue, Ryusuke Yonezawa, Hiroshi Saito, Nobuaki Hamazaki, Ryota Matsuzawa, Kohei Nozaki, Masashi Yamashita, Kazuki Wakaume, Yoshiko Endo, Emi Maekawa, Minako Yamaoka-Tojo, Takaaki Shiono, Takayuki Inomata, Junya Ako

Abstract

As frailty in older patients with acute heart failure (AHF) has an adverse effect on clinical outcomes, the addition of electrical muscle stimulation (EMS) to exercise-based early rehabilitation may improve the effects of treatment. Post hoc analysis was performed on a randomized controlled study for clinical outcomes and prespecified subgroups (ACTIVE-EMS: UMIN000019551). In this trial, 31 AHF patients aged ≥ 75 years with frailty (Short Physical Performance Battery [SPPB] score 4-9) were randomized 1:1 to receive treatment with an early rehabilitation program only (n = 16) or early rehabilitation with add-on EMS therapy (n = 15) for 2 weeks. Changes in physical function and cognitive function between baseline and after two weeks of treatment were assessed. There were no adverse events during the EMS period. The EMS group showed significantly greater changes in quadriceps' isometric strength and SPPB compared to the control group, and EMS therapy showed uniform effects in the prespecified subgroups. There were no significant differences in the changes in other indexes of physical function and cognitive function between groups. There was no significant difference in the rate of heart failure hospitalization at 90 days between groups. In conclusion, older AHF patients with frailty showed greater improvement in lower extremity function with the addition of EMS therapy to early rehabilitation without adverse events.

Keywords: acute decompensated heart failure; early rehabilitation; electrical muscle stimulation; exercise; frail; muscle strength; physical function.

Conflict of interest statement

K.K. has received research and scholarship funding from Eiken Chemical Co., Ltd. Y.M. is affiliated with a department endowed by Philips Respironics, ResMed, Teijin Home Healthcare, and Fukuda Denshi, and received a honorarium from Novartis Japan and Otsuka Pharmaceutical Co. Other authors have no conflict of interest to disclose.

Figures

Figure 1
Figure 1
Belt electrode skeletal muscle electrical stimulation.
Figure 2
Figure 2
Study flow diagram. ACS, acute coronary syndrome; AS, aortic stenosis; EMS, electrical muscle stimulation; HF, heart failure; HOCM, hypertrophic obstructive cardiomyopathy; MS, mitral stenosis; SPPB, short physical performance battery.
Figure 3
Figure 3
Waterfall plots of changes in physical and cognitive function. BW, body weight; CI, confidence interval; EMS, electrical muscle stimulation.
Figure 4
Figure 4
Prespecified subgroup analysis of the primary outcome. Values are expressed as means ± SD. BW, body weight; CI, confidence interval; EMS, electrical muscle stimulation; LVEF, left ventricular ejection fraction; QIS, quadriceps isometric strength; 6MWD, 6-min walking distance.

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Source: PubMed

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