UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002272 |
|---|---|
| Receipt number | R000002473 |
| Scientific Title | The effect of low intensity resistance exercise with blood flow restriction in patients with cardiovascular disease. |
| Date of disclosure of the study information | 2009/08/01 |
| Last modified on | 2009/07/30 13:48:37 |
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Basic information
Public title
The effect of low intensity resistance exercise with blood flow restriction in patients with cardiovascular disease.
Acronym
Blood flow restriction for patients with cardiovascular disease
Scientific Title
The effect of low intensity resistance exercise with blood flow restriction in patients with cardiovascular disease.
Scientific Title:Acronym
Blood flow restriction for patients with cardiovascular disease
Region
| Japan |
Condition
Condition
cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of low intensity resistance exercise with blood flow restriction for muscle hypertrophy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
VO2max,AT
volume and CSA of muscle detected by MRI
maximal voluntary contraction
Key secondary outcomes
GH,insulin etc
BNP
hsCRP,PTX3
cytokine etc
FMD
Body pletysmography
ABI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
4 months
twice a week,resistance training with blood flow restriction
Interventions/Control_2
4 months
twice a week,resistance training without blood flow restriction
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
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
patients with ischemic heart disease and congestive heart failure
Key exclusion criteria
patients with hemodialysis and after bypass surgery for peripheral artery disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sahara Makoto |
Organization
University ot Tokyo hospital
Division name
department of cardiovascular medicine
Zip code
Address
Hongo 7-3-1,Bunkyo-ku,Tokyo
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Morita Toshihiro |
Organization
University ot Tokyo hospital
Division name
division of ischemic circulatory phisiology
Zip code
Address
Hongo 7-3-1,Bunkyo-ku,Tokyo
TEL
03-3815-5411
Homepage URL
moorilyn@gmail.com
Sponsor or person
Institute
University ot Tokyo hospital
Institute
Department
Personal name
Funding Source
Organization
University ot Tokyo hospital
Organization
Division
Category of Funding Organization
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
| 2009 | Year | 08 | 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
Date of protocol fixation
| 2009 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 30 | Day |
Last modified on
| 2009 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002473
