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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017539
Receipt No. R000019972
Scientific Title Comprehensive evaluation of cardiac rehabilitation in cardiovascular diseases and lifestyle-related diseases
Date of disclosure of the study information 2015/05/13
Last modified on 2017/12/10

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Basic information
Public title Comprehensive evaluation of cardiac rehabilitation in cardiovascular diseases and lifestyle-related diseases
Acronym Impact of cardiac rehabilitation in cardiovascular diseases
Scientific Title Comprehensive evaluation of cardiac rehabilitation in cardiovascular diseases and lifestyle-related diseases
Scientific Title:Acronym Impact of cardiac rehabilitation in cardiovascular diseases
Region
Japan

Condition
Condition Cardiovascular diseases and lifestyle-related diseases
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the impact of cardiac rehabilitation in cardiovascular diseases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Exercise capacity, quality of life, depression and anxiety
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Cardiac rehabilitation
Interventions/Control_2 Control
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

Not applicable
Gender Male and Female
Key inclusion criteria Acute myocardial infarction and heart failure
Class B (AHA exercise standard; Circulation 2001; 104: 1694-1740)
Key exclusion criteria Class A, C, D (AHA exercise standard; Circulation 2001; 104: 1694-1740)
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiichi Fukuda
Organization Keio University School of Medicine
Division name Division of Cardiology
Zip code
Address 35 Shinanomachi Shinjukuku-ku
TEL 0358436702
Email keiocardio@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kohno
Organization Keio University School of Medicine
Division name Division of Cardiology
Zip code
Address 35 Shinanomachi Shinjukuku-ku
TEL 0358436702
Homepage URL
Email keiocardio@gmail.com

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization MEIJI YASUDA LIFE FOUNDATION OF HEALTH AND WELFARE
Organization
Division
Category of Funding Organization Non profit foundation
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
2015 Year 05 Month 13 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 Terminated
Date of protocol fixation
2014 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 06 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 12 Month 31 Day
Date trial data considered complete
2016 Year 12 Month 31 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 05 Month 13 Day
Last modified on
2017 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019972

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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