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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017833
Receipt No. R000020658
Scientific Title Usefulness of home-based rehabilitation in chronic heart failure
Date of disclosure of the study information 2015/06/07
Last modified on 2015/06/07

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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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