UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026841 |
|---|---|
| Receipt number | 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 14:39:10 |
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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
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
sasaken@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine, Division of Cardiovascular Medicine, Department of Internal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030807
