UMIN-CTR Clinical Trial

Basic information
Public title	Usefulness of home-based rehabilitation in chronic heart failure
Acronym	HBR HF trial
Scientific Title	Usefulness of home-based rehabilitation in chronic heart failure
Scientific Title:Acronym	HBR HF trial
Region	Japan

Condition
Condition	chronic heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of home-based nonsupervised cardiac rehabilitation in patients with chronic heart failure
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Six-minute walk distance
Key secondary outcomes	Dual-energy X-ray absorptiometry(DEXA) QOL:MLHFQ(the Minnesota Living with Heart Failure Questionnaire),hospital anxiety and depression scale(HADS) Biomarkers:Myostatin, Brain-derived neurotrophic factor(BDNF), cytokines Safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Nonsupervised muscle strengthening tarining program + usual exercise prescription (training) for heart failure
Interventions/Control_2	Usual exercise prescription (training) for heart failure
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Chronic heart failure (NYHA function class II or III)
Key exclusion criteria	Unsatble angine pectoris Severe valvular heart disease Moderate and severe left ventricular outflow obstruction/stenosis Active myocarditis Acute systemic illness/high fever Moderate and severe aortic aneurysm/hepertension/thrombophlebitis, Thromboembolism(within 2 weeks) NYHA functional class IV or administration of intravenous inotropics Decrease of blood pressure on exercise Excercise induced arrhythmia Advanced AV block
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobuhisa Hagiwara
Organization	Tokyo Women's Medical University
Division name	Cardiology
Zip code
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-8111
Email	mhagi@hij.twmu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tsuyoshi Shiga
Organization	Tokyo Women's Medical University
Division name	Cardiology
Zip code
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-8111
Homepage URL
Email	mshiga@hij.twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Health and Labor Sciences Research Grant
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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	東京女子医科大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 07 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	2015 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date	2015 Year 06 Month 13 Day
Last follow-up date	2017 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 06 Month 07 Day
Last modified on	2015 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020658

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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