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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002272
Receipt No. 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

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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
Email

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
Email moorilyn@gmail.com

Sponsor
Institute University ot Tokyo hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002473

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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