A single center, open-labeled, pilot study to evaluate the safety and efficacy of cardiac cycle-synchronized electrical lower limb muscle stimulation therapy for cardiovascular disease

A single center, open-labeled, pilot study to evaluate the safety and efficacy of cardiac cycle-synchronized electrical lower limb muscle stimulation therapy for cardiovascular disease - Cardiac cycle-synchronized electrical lower limb muscle stimulation therapy for cardiovascular disease

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026841

Enrollment

Registered

2017-04-04

Start date

2015-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Latent heart failure (NYHA class: II-III), ischemic heart disease (CCS class: II-III), peripheral artery disease (Fontaine class: II-IV), pulmonary artery hypertension (WHO class: II-III), and healthy adult

Interventions

The subject is set up the cardiac cycle-synchronized electrical lower limb muscle stimulation system in the decubitus position. Then the subject trains the lower limb muscle for 20 minutes by controll

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Latent CHF NYHA class: II-III CTR<70% on chest X-P LVEF>30% on echo-cardiogram Ischemic heart disease Old myocardial infarction or stable angina with treated by acceptable revascularization before 30 days Peripheral artery disease Arteriosclerosis obliterans or Buergers disease with treated by acceptable revascularization before 30 days Fontaine class: II-IV Pulmonary artery hypertension WHO class: II-III Mean pulmonary artery pressure<50 mmHg No deep vein thrombus and pulmonary artery thrombus * It is necessary that any subjects have already received possible treatment before the entry.

Exclusion criteria

Exclusion criteria: Hard fitting of the equipment of this study Skin, muscle, or bone disease in limbs Implantation of cardiac pacemaker Uncontrolled hypertension Blood pressure at rest>160/100 mmHg Uncontrolled arrhythmia Arrhythmia with unstable hemodynamics Pregnancy Malignant disease on no-remission

Design outcomes

Primary

Measure	Time frame
At the end of the therapy, we will assess following safeties and efficacies. Safety: skin and/or muscle injury by electrical stimulation, cardiovascular adverse events, and hemodynamic change. Efficacy: daily symptoms, physical examination, glycolipid metabolism, cardiovascular function, hemodynamics, locomotive function, and body compositions including fat, muscle, and bone.	—

Countries

Japan

Contacts

Public ContactKen-ichiro Sasaki

Kurume University School of Medicine Division of Cardiovascular Medicine, Department of Internal Medicine

sasaken@med.kurume-u.ac.jp0942-31-7562

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026