Open AccessEffects 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
Author(s) -
Tanaka Shinya,
Kamiya Kentaro,
Matsue Yuya,
Yonezawa Ryusuke,
Saito Hiroshi,
Hamazaki Nobuaki,
Matsuzawa Ryota,
Nozaki Kohei,
Wakaume Kazuki,
Endo Yoshiko,
Maekawa Emi,
YamaokaTojo Minako,
Shiono Takaaki,
Inomata Takayuki,
Masuda Takashi,
Ako Junya
Publication year - 2017
Publication title -
clinical cardiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.263
H-Index - 72
eISSN - 1932-8737
pISSN - 0160-9289
DOI - 10.1002/clc.22845
Subject(s) - medicine , rehabilitation , heart failure , clinical endpoint , randomized controlled trial , physical therapy , clinical trial , population , isometric exercise , multicenter trial , physical medicine and rehabilitation , multicenter study , environmental health
In 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.