UMIN-CTR Clinical Trial

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
Institute	Rehabilitation Department, Kiwa Hospital
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056566