UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017833
Receipt number 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 13:08:19

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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 or person

Institute

Tokyo Women's Medical University

Institute

Department

Personal name



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

Value
https://center6.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