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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026841
Receipt No. R000030807
Scientific Title 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
Date of disclosure of the study information 2017/04/04
Last modified on 2018/10/09

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Basic information
Public title 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
Acronym Cardiac cycle-synchronized electrical lower limb muscle stimulation therapy for cardiovascular disease
Scientific Title 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
Scientific Title:Acronym Cardiac cycle-synchronized electrical lower limb muscle stimulation therapy for cardiovascular disease
Region
Japan

Condition
Condition 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
Classification by specialty
Cardiology Geriatrics Vascular surgery
Orthopedics Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of cardiac cycle-synchronized electrical lower limb muscle stimulation therapy for cardiovascular disease patients with a decrease in the activity of daily living
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes 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.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 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 controlled electrical muscle stimulation without an increase in the cardiac workload. The muscle training is performed twice a day, two or three times a week, and for up to 24 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit
80 years-old >=
Gender Male and Female
Key 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.
Key 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
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken-ichiro Sasaki
Organization Kurume University School of Medicine
Division name Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
Address Asahi-machi 67, Kurume, 830-0011
TEL 0942-31-7562
Email sasaken@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken-ichiro Sasaki
Organization Kurume University School of Medicine
Division name Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
Address Asahi-machi 67, Kurume, 830-0011
TEL 0942-31-7562
Homepage URL
Email sasaken@med.kurume-u.ac.jp

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

Funding Source
Organization Kurume University School of Medicine, Division of Cardiovascular Medicine, Department of Internal Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2015 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 03 Day
Last modified on
2018 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030807

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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