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Evaluation of efficacy and safety of hybrid training system on chronic cardiovascular diseases

Evaluation of efficacy and safety of hybrid training system on chronic cardiovascular diseases - Hybrid training for chronic cardiovascular diseases

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013265
Enrollment
75
Registered
2014-05-01
Start date
2014-05-01
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)

Interventions

The subject performs exercise for bending and stretching of the knees with a hybrid training system, which is muscle training using both voluntary muscle contraction and electrically stimulated antago

Sponsors

Division of Cardio-Vascular Medicine, Department of Internal Medicine, Kurume University School of Medicine
Lead Sponsor
Department of Orthopedic Surgery, Kurume University School of Medicine
Collaborator

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 adequate revascularization before 30 days Peripheral artery disease Arteriosclerosis obliterans or Buerger's disease with treated by adequate 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 acute pulmonary artery thrombus * It is necessary that any subjects have already received enough treatment before the entry.

Exclusion criteria

Exclusion criteria: Hard to fit the training device 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 diseases on no-remission

Design outcomes

Primary

MeasureTime frame
Evaluation 24 weeks after the training. Safety: injuries of skin and/or muscle by electrical stimulation during the training. Efficacy: symptoms, metabolic disorder (DM, dyslipidemia, etc.), cardiac function, vascular function, and hemodynamics.

Countries

Japan

Contacts

Public ContactKen-ichiro Sasaki

Kurume University The Cardiovascular Research Institute

sasaken@med.kurume-u.ac.jp0942-31-7580

Outcome results

None listed

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