UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016978 |
|---|---|
| Receipt number | R000018436 |
| Scientific Title | Occurrence and significance of cardiac-locomotor synchronization in patients with cardiac disease |
| Date of disclosure of the study information | 2015/03/30 |
| Last modified on | 2015/04/29 10:08:53 |
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Basic information
Public title
Occurrence and significance of cardiac-locomotor synchronization in patients with cardiac disease
Acronym
Occurrence and significance of cardiac-locomotor synchronization in patients with cardiac disease
Scientific Title
Occurrence and significance of cardiac-locomotor synchronization in patients with cardiac disease
Scientific Title:Acronym
Occurrence and significance of cardiac-locomotor synchronization in patients with cardiac disease
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology | Cardiovascular surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate occurrence factor and physiological significance of cardiac-locomotor synchronization in patients with coronary artery disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Strength of cardiac-locomotor synchronization during walking
Key secondary outcomes
muscle blood flow of lower leg, oxygen uptake, oxygen pulse, Rating of Perceived Exertion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Subject: patients with cardiac disease
Duration: for a day
Content: cardiopulmonary exercise testing with bicycle ergometer, walking on treadmill
Time: once
Interventions/Control_2
Subject: normal subject
Duration: for a day
Content: cardiopulmonary exercise testing with bicycle ergometer, walking on treadmill
Time: once
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male
Key inclusion criteria
Coronary artery disease patient with the stable condition,
healthy people of the same age
Key exclusion criteria
massive heart failure, arhythmia, respiratory dysfunction, people who can not walk without support
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinta Takeuchi |
Organization
Hamamatsu University School of Medicine, University Hospital
Division name
Rehabilitation department
Zip code
Address
1-20-1 Handayama, Higashiku, Hamamatsu-shi, Shizuoka, Japan
TEL
053-435-2746
take.shin1110@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinta Takeuchi |
Organization
Hamamatsu University School of Medicine, University Hospital
Division name
Rehabilitation department
Zip code
Address
1-20-1 Handayama, Higashiku, Hamamatsu-shi, Shizuoka, Japan
TEL
053-435-2746
Homepage URL
take.shin1110@gmail.com
Sponsor or person
Institute
Hamamatsu University School of Medicine, University Hospital, Rehabilitation department
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
浜松医科大学医学部附属病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 30 | 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
In this study, we compared the strength of Cardiac-Locomotor Synchronization (CLS) in a control group with patients with ischemic heart disease. As a result, the strength of CLS indicated the high price significantly in a ischemic heart disease patient. The peak oxygen uptake and the peak oxygen pulse indicated low value significantly in patients with ischemic heart disease. We concluded that physical fitness and/or cardiovascular function affected the occurrence of CLS during walking.
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 | 07 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 04 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 30 | Day |
Last modified on
| 2015 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018436
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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