• Clinical cardiology · Dec 2017

    Randomized Controlled Trial Multicenter Study

    Effects of Acute Phase Intensive Electrical Muscle Stimulation in Frail Elderly Patients With Acute Heart Failure (ACTIVE-EMS): Rationale and protocol for a multicenter randomized controlled trial.

    • Shinya Tanaka, Kentaro Kamiya, Yuya Matsue, Ryusuke Yonezawa, Hiroshi Saito, Nobuaki Hamazaki, Ryota Matsuzawa, Kohei Nozaki, Kazuki Wakaume, Yoshiko Endo, Emi Maekawa, Minako Yamaoka-Tojo, Takaaki Shiono, Takayuki Inomata, Takashi Masuda, and Junya Ako.
    • Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kitasato University, Kanagawa, Japan.
    • Clin Cardiol. 2017 Dec 1; 40 (12): 1189-1196.

    AbstractIn elderly patients with acute heart failure (AHF), clinical outcome is adversely affected by frailty. Although a number of potentially effective interventions for frailty have been reported, little is known about the effects of rehabilitation programs in frail elderly AHF patients. We postulated that addition of electrical muscle stimulation (EMS), which induces muscle contraction without requiring patient volition, to early rehabilitation would be efficacious in frail elderly AHF patients. The ACTIVE-EMS (Effects of Acute Phase Intensive Electrical Muscle Stimulation in Frail Elderly Patients With AHF; UMIN000019551) trial is a multicenter, randomized controlled trial that will enroll 80 patients from 3 hospitals in Japan. AHF patients age ≥ 75 years positive for frailty, defined as Short Physical Performance Battery score 4 to 9, will be randomly assigned to receive early rehabilitation program only or EMS add-on therapy for 2 weeks. The primary endpoint of the trial is the change in quadriceps isometric strength between baseline and 2 weeks, with changes in physical function and cognitive function, and clinical safety and feasibility of EMS therapy as secondary outcomes. ACTIVE-EMS is the first randomized trial to evaluate the clinical effectiveness of adding EMS therapy to early rehabilitation in frail elderly AHF patients. The results of this study will provide insight for the development of appropriate rehabilitation programs for this high-risk population.© 2017 Wiley Periodicals, Inc.

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