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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013265
Receipt No. R000015474
Scientific Title Evaluation of efficacy and safety of hybrid training system on chronic cardiovascular diseases
Date of disclosure of the study information 2014/05/01
Last modified on 2019/03/04

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Basic information
Public title Evaluation of efficacy and safety of hybrid training system on chronic cardiovascular diseases
Acronym Hybrid training for chronic cardiovascular diseases
Scientific Title Evaluation of efficacy and safety of hybrid training system on chronic cardiovascular diseases
Scientific Title:Acronym Hybrid training for chronic cardiovascular diseases
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)
Classification by specialty
Cardiology Vascular surgery Orthopedics
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of hybrid training system in chronic cardiovascular disease patients with slight or marked limitation of physical activity
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes 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.
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 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 antagonist, in position of sitting on chair. Each exercise session consisted of 10 sets of 10 reciprocal knee flexion and extension contractions and a 1-min rest interval. The sessions are scheduled twice a week for 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 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.
Key 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
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken-ichiro Sasaki
Organization Kurume University
Division name The Cardiovascular Research Institute
Zip code
Address 67 Asahi-machi, Kurume, 830-0011
TEL 0942-31-7580
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
Division name The Cardiovascular Research Institute
Zip code
Address 67 Asahi-machi, Kurume, 830-0011
TEL 0942-31-7580
Homepage URL
Email sasaken@med.kurume-u.ac.jp

Sponsor
Institute Division of Cardio-Vascular Medicine, Department of Internal Medicine, Kurume University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Orthopedic Surgery, Kurume University School of Medicine
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 久留米大学病院(福岡県)、久留米大学医療センター(福岡県)

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 01 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 Completed
Date of protocol fixation
2014 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 25 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015474

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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