UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013265 |
|---|---|
| Receipt number | 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 11:39:02 |
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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
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
sasaken@med.kurume-u.ac.jp
Sponsor or person
Institute
Division of Cardio-Vascular Medicine, Department of Internal Medicine, Kurume University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015474
| Research Plan | |
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| Registered date | File name |
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