UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053956 |
|---|---|
| Receipt number | R000061505 |
| Scientific Title | Japanese multi-center randomized control trial of physical therapy for older patients with acute heart failure and frailty |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2025/09/24 19:18:04 |
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Basic information
Public title
Japanese multi-center randomized control trial of physical therapy for older patients with acute heart failure and frailty
Acronym
J REHAB-HF
Scientific Title
Japanese multi-center randomized control trial of physical therapy for older patients with acute heart failure and frailty
Scientific Title:Acronym
J REHAB-HF
Region
| Japan |
Condition
Condition
Older patients with heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of a systematic personal exercise programe on physical function in Japanese older patients with heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Short physical performance battery
Key secondary outcomes
Grip strength
Gait speed
Arm, Calf circumference
Barthel Index
J-CHS Criteria, Clinical Frailty Scale, MAKIZAKO, KCL
EQ-5D-5L
One year mortality or hospitalization
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
A systemic personal exercise intervention
Interventions/Control_2
Conventional ecercise training
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
Acute heart failure patients with
Age more than 65 years old
Able to independent walking pre admission
Key exclusion criteria
At the time of randomization, none of the following conditions may exist:
Acute myocardial infarction based on clinical diagnosis
Requiring care in an intensive care unit
Planned discharge other than to where the participant will live independently
Dementia that precludes ability to participate in rehabilitation and follow study protocols
Impairment from stroke, injury or other medical disorder that precludes participation in the intervention
Advanced chronic kidney disease or dialysis
Prior cardiac transplantation or planned within the next 6 months
Expected use of continuous intravenous inotropic therapy after discharge
Ventricular assist device or anticipated within the next 6 months
Severe aortic valve stenosis
Already actively participating in facility-based cardiac rehabilitation
Anticipated hospital discharge before baseline study measures could be completed
SPPB score more than or equal to 10 points
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | YUJI |
| Middle name | |
| Last name | KONO |
Organization
Fujita Health University Hospital
Division name
Department of Rehabilitation
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL
0562-93-2155
yt-kono@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | YUJI |
| Middle name | |
| Last name | KONO |
Organization
Fujita Health University Hospital
Division name
Department of Rehabilitation
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL
0562-93-2155
Homepage URL
yt-kono@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University Hospital
Kitasato University Hospital
Sapporo Medical University Hospital
Shinshu University Hospital
Tohoku University Hospital
Matsushita Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research C
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
Fujita Health University IRB Center
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.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
藤田医科大学病院（愛知県）、北里大学病院（神奈川県）、札幌医科大学附属病院（北海道）、信州大学医学部附属病院（長野県）、東北大学病院（宮城県）、パナソニック健康保険組合松下記念病院 （大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/40393201/
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 24 | Day |
Last modified on
| 2025 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061505
