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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.

ABSTRACT: 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.

SUBMITTER: Tanaka S

PROVIDER: S-EPMC6490620 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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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.

Tanaka Shinya S Kamiya Kentaro K Matsue Yuya Y Yonezawa Ryusuke R Saito Hiroshi H Hamazaki Nobuaki N Matsuzawa Ryota R Nozaki Kohei K Wakaume Kazuki K Endo Yoshiko Y Maekawa Emi E Yamaoka-Tojo Minako M Shiono Takaaki T Inomata Takayuki T Masuda Takashi T Ako Junya J

Clinical cardiology 20171216 12

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 ...[more]

PMID: 29247531

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Project description:IntroductionThe phenomenon of population ageing is accompanied by increases in the number of elderly haemodialysis patients worldwide. The incidence of frailty is high in the haemodialysis population and is associated with poor clinical outcome. Although several interventions have been developed for use in general haemodialysis patients, the efficacy of such rehabilitation programmes in frail elderly patients on haemodialysis has not been elucidated. Here, we examined whether electrical muscle stimulation (EMS) would show beneficial effects in frail elderly patients on haemodialysis.Methods and analysisThis is a randomised, two-period, controlled crossover trial, which will enrol 20 patients. Haemodialysis patients aged ≥65 years and defined as frail (ie, Short Physical Performance Battery score 4-9), will be randomly assigned to either group 1 (EMS intervention beginning in treatment period I, followed by reallocation as controls in treatment period II after a 5-week washout period) or group 2 (opposite schedule) in a 1:1 ratio. The two intervention periods will last 5 weeks each with an intervening washout period of 5 weeks. In the EMS intervention group, the treatment will be applied to the skeletal muscle of the entire lower extremity for 5 weeks, three times/week for 30-40 min during haemodialysis. The primary outcome of this study is the change in quadriceps isometric strength after the interventions. The secondary outcomes are the changes in physical function, physical activity, difficulty in activities of daily living, body composition, cognitive function, depressive symptoms, quality of life, blood test results and the clinical safety and feasibility of EMS therapy.Ethics and disseminationThis study has been approved by the institutional review board/ethics committee of Kitasato University Allied Health Sciences. This study will be reported in peer reviewed publications and at conference presentations.Trial registration numberUMIN000032501.

Dataset Information

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.

Publications

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.

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