UMIN-CTR Clinical Trial

Basic information
Public title	Effects of cardiac rehabilitation in the patients with heart failure -Changing of Muscle mass with exercise-
Acronym	Effects of cardiac rehabilitation for skeletal muscle
Scientific Title	Effects of cardiac rehabilitation in the patients with heart failure -Changing of Muscle mass with exercise-
Scientific Title:Acronym	Effects of cardiac rehabilitation for skeletal muscle
Region	Japan

Condition
Condition	Heart failure
Classification by specialty	Cardiology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate effects of cardiac rehabilitation for skeletal muscle.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the skeletal muscle in cardiac rehabilitation with heart failure patients.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with chronic heart failure in Kansai Medical University Health Science Center from April 2013 to March 2018. 1.LVEF<50%,NTpro-BNP>=400pg/ml 2.Independent living 3.Cardiac rehabilitation was started before 2017/9.
Key exclusion criteria	1.Patients with serious heart failure,arrhythmia,respiratory failure,metabolic diseases. 2.Patients who has underlying disease which is serious,untreated and insufficient treatment. 3.Minor and no competent individual. 4.Patients who rejected this study. 5.Patients whom principal investigators and the research supervisor.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yutaka Middle name Last name Kimura
Organization	Kansai Medical University Hospital
Division name	Health Science
Zip code	5731191
Address	2-3-1 Shinmachi Hirakata city Osaka Japan
TEL	0728040101
Email	kimuray@hirakata.kmu.ac.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Kurose
Organization	Kansai Medical University
Division name	Health Science
Zip code	5731010
Address	2-5-1 Shinmachi Hirakata city Osaka Japan
TEL	0728040101
Homepage URL
Email	tsutsumi@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Hospital
Institute
Department

Funding Source
Organization	Nothing
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Ethics Review Committee of Kansai Medical University
Address	2-5-1-701 Shinmachi Hirakata city Osaka Japan
Tel	072-804-0101
Email	rinriirb@hirakata.kmu.ac.jp

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	2016 Year 10 Month 15 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	Open public recruiting
Date of protocol fixation	2016 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date	2016 Year 09 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective observational study

Management information
Registered date	2016 Year 10 Month 11 Day
Last modified on	2022 Year 10 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027936