UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049662
Receipt number R000056566
Scientific Title Efficacy of inpatient cardiac rehabilitation for heart failure patients
Date of disclosure of the study information 2022/12/01
Last modified on 2022/12/05 11:53:55

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Basic information

Public title

Efficacy of inpatient cardiac rehabilitation for heart failure patients

Acronym

Efficacy of inpatient cardiac rehabilitation for heart failure patients

Scientific Title

Efficacy of inpatient cardiac rehabilitation for heart failure patients

Scientific Title:Acronym

Efficacy of inpatient cardiac rehabilitation for heart failure patients

Region

Japan


Condition

Condition

Heart failure

Classification by specialty

Cardiology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to clarify that cardiac rehabilitation decreases the incidence of cause-specific events in elderly heart failure patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Event rates by cause at 12 months post-discharge

Key secondary outcomes

Changes in motor function, cognitive function, depression test, activities of daily living, and quality of life before and after cardiac rehabilitation


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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1, Elderly patients over 60 years old.
2, Patients with chronic heart failure who are treated according to the current guidelines and admitted to our hospital.
3, Patients who have given written consent to participate in this study after being informed of its significance.

Key exclusion criteria

1, Patients who could not give consent.
2, Patients with contraindications to active exercise therapy.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Arata
Middle name
Last name Takahashi

Organization

Kiwa Hospital

Division name

Rehabilitation Department

Zip code

648-0085

Address

18-1 Kishigami, Hashimoto City, Wakayama Prefecture, Japan

TEL

0736-33-5000

Email

reha@nanroukai.or.jp


Public contact

Name of contact person

1st name Arata
Middle name
Last name Takahashi

Organization

Kiwa Hospital

Division name

Rehabilitation Department

Zip code

648-0085

Address

18-1 Kishigami, Hashimoto City, Wakayama Prefecture, Japan

TEL

0736-33-5000

Homepage URL


Email

reha@nanroukai.or.jp


Sponsor or person

Institute

Rehabilitation Department, Kiwa Hospital

Institute

Department

Personal name



Funding Source

Organization

Kiwa Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Clinical Research Center, Wakayama Medical University Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kiwa Hospital

Address

18-1 Kishigami, Hashimoto City, Wakayama Prefecture, Japan

Tel

0736-33-5000

Email

kiwa.iji@nanroukai.or.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

紀和病院(和歌山県)


Other administrative information

Date of disclosure of the study information

2022 Year 12 Month 01 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

2022 Year 11 Month 29 Day

Date of IRB

2022 Year 11 Month 29 Day

Anticipated trial start date

2022 Year 12 Month 05 Day

Last follow-up date

2025 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective study
Recruitment period 12/5/2022 - 4/30/2024
Method of recruitment of eligible applicants Inpatients with heart failure who meet the selection criteria


Management information

Registered date

2022 Year 12 Month 01 Day

Last modified on

2022 Year 12 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056566


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name