UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050161 |
|---|---|
| Receipt number | R000056859 |
| Scientific Title | Effect of tailored cardiac rehabilitation according to the nutritional status in older patients with heart failure |
| Date of disclosure of the study information | 2023/01/27 |
| Last modified on | 2023/01/27 14:07:59 |
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Basic information
Public title
Effect of cardiac rehabilitation on patient outcome in chronic heart failure
Acronym
CHF Rehabilitation Study
Scientific Title
Effect of tailored cardiac rehabilitation according to the nutritional status in older patients with heart failure
Scientific Title:Acronym
Effect of tailored cardiac rehabilitation
Region
| Japan |
Condition
Condition
Herat failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to clarify the effect of in-hospital tailored cardiac rehabilitation according to nutritional status and frailty on functional outcome at discharge.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Motor function
2.Functional Independence measure
Key secondary outcomes
1.Cognitive function
2,Health-related quality of life
3.Days from the admission to the initiation of rehabilitation
4.Total amount of rehabilitation
5.Period of hospital stay
6.Functional outcome at discharge
7.Readmission rate until 1 year after the discharge
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted to the National Cerebral and Cardiovascular Center due to heart failure with acute decompensation, who underwent in-hospital CR between May 2018 and March 2025.
Key exclusion criteria
Patients with contraindication of exercise training indicated by the guideline of cardiac rehabilitation in Japan.
Patients with refusal to participate in the present study.
Target sample size
3500
Research contact person
Name of lead principal investigator
| 1st name | Chiaki |
| Middle name | |
| Last name | Yokota |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Stroke and Cardiovascular Rehabiritation
Zip code
564-8565
Address
6-1 Kishibe-shimmachi, Suita, Osaka, Japan
TEL
+81-6-6170-1070
cyokota@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Chiaki |
| Middle name | |
| Last name | Yokota |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Stroke and Cardiovascular Rehabiritation
Zip code
564-8565
Address
6-1 Kishibe-shimmachi, Suita, Osaka, Japan
TEL
+81-6-6170-1070
Homepage URL
cyokota@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center
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
Ethics Committee of National Cerebral and Cardiovascular Center
Address
6-1 Kishibe-shimmachi, Suita, Osaka, Japan
Tel
+81-6-6170-1070
rec-office-ac@ncvc.go.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
| 2023 | Year | 01 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2023 | Year | 01 | Month | 27 | Day |
Last modified on
| 2023 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056859
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
