UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comprehensive evaluation of cardiac rehabilitation in cardiovascular diseases and lifestyle-related diseases
Title of the study (Brief title)	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	Keiichi Fukuda
Organization	Keio University School of Medicine
Division name	Division of Cardiology
Address	35 Shinanomachi Shinjukuku-ku
TEL	0358436702
Email	keiocardio@gmail.com

Public contact
Name of contact person	Takashi Kohno
Organization	Keio University School of Medicine
Division name	Division of Cardiology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 01 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019972