UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040062
Receipt number R000045679
Scientific Title Impact of cardiac rehabilitation interruption in elderly patients with chronic heart failure
Date of disclosure of the study information 2020/04/13
Last modified on 2023/04/09 23:17:56

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Basic information

Public title

Impact of cardiac rehabilitation interruption in elderly patients with chronic heart failure

Acronym

Interruption of cardiac rehabilitation in patients with heart failure

Scientific Title

Impact of cardiac rehabilitation interruption in elderly patients with chronic heart failure

Scientific Title:Acronym

Interruption of cardiac rehabilitation in patients with heart failure

Region

Japan


Condition

Condition

Chronic heart failure

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of interruption of cardiac rehabilitation on heart failure in the elderly.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cardiopulmonary exercise test after interruption of cardiac rehabilitation

Key secondary outcomes

Stress echocardiography
Biochemical test
Adverse event
Echocardiography
Dynamometry


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

One month suspension of cardiac rehabilitation

Interventions/Control_2

One month of cardiac rehabilitation

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

A patient who was hospitalized for heart failure, underwent acute cardiac rehabilitation, and transitioned to outpatient cardiac rehabilitation.

Key exclusion criteria

none

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Masaru
Middle name
Last name Araki

Organization

University of Occupational and Environmental Health

Division name

Second department of internal medicine

Zip code

8078556

Address

1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan

TEL

093-603-1611

Email

maraki@med.uoeh-u.ac.jp


Public contact

Name of contact person

1st name Masaru
Middle name
Last name Araki

Organization

University of Occupational and Environmental Health

Division name

Second department of internal medicine

Zip code

8078556

Address

1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan

TEL

093-603-1611

Homepage URL


Email

maraki@med.uoeh-u.ac.jp


Sponsor or person

Institute

University of Occupational and Environmental Health

Institute

Department

Personal name



Funding Source

Organization

JSPS KAKENHI

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Occupational and Environmental Health Ethics Committee

Address

1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan

Tel

093-691-7205

Email

Daigakukanri@mbox.pub.uoeh-u.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

2020 Year 04 Month 13 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

2020 Year 03 Month 18 Day

Date of IRB

2020 Year 03 Month 18 Day

Anticipated trial start date

2020 Year 04 Month 13 Day

Last follow-up date

2026 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 04 Month 05 Day

Last modified on

2023 Year 04 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045679


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name