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
Phase 1
- Conditions
- atent 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
- Registration Number
- JPRN-UMIN000026841
- Lead Sponsor
- Kurume University School of Medicine, Division of Cardiovascular Medicine, Department of Internal Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method