UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058267 |
|---|---|
| Receipt number | R000066613 |
| Scientific Title | Impact of physical performance improvement on ADHF |
| Date of disclosure of the study information | 2025/06/24 |
| Last modified on | 2025/06/24 21:18:56 |
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Basic information
Public title
Physical performance impacts heart failure readmission in older, frail patients with acute decompensated heart failure
Acronym
Impact of physical performance improvement on ADHF
Scientific Title
Impact of physical performance improvement on ADHF
Scientific Title:Acronym
Impact of physical performance improvement on ADHF
Region
| Japan |
Condition
Condition
acute decompensated heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of changes in physical performance on the prognosis of patients with acute/decompensated heart failure
Basic objectives2
Others
Basic objectives -Others
Safety,Efficacy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
heart failure readmission
Key secondary outcomes
all-cause mortality
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
SPPB <9 scores at the admission
Key exclusion criteria
age <18 years
non-ambulatory or requiring assistance before admission
malignant disease with a prognosis of 6 months or less
physical performance not assessed at admission or discharge
SPPB scores >9 at the admission
need for advanced mechanical support(including intubation, intra-aortic balloon pumping, and extracorporeal membrane oxygenation) precluding physical evaluation within 4 days of admission
hospitalization duration <7 days
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Nakaya |
Organization
Uwajima City Hospital
Division name
Department of Rehabilitation
Zip code
798-0044
Address
1-1 Goten-machi, Uwajima city, Ehime
TEL
0895-25-1111
y.nakaya.pt@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Nakaya |
Organization
Uwajima City Hospital
Division name
Department of Rehabilitation
Zip code
798-0044
Address
1-1 Goten-machi, Uwajima city, Ehime
TEL
0895-25-1111
Homepage URL
y.nakaya.pt@gmail.com
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Uwajima City Hospital Clinical Research Review Board
Address
1-1 Goten-machi, Uwajima city, Ehime
Tel
0895-25-1111
y.nakaya.pt@gmail.com
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
| 2025 | Year | 06 | Month | 24 | 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
1253
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This cohort study included 1,253 patients with ADHF hospitalised between January 2018 and December 2023.This is a retrospective observational study.To investigate post-discharge outcomes.
Management information
Registered date
| 2025 | Year | 06 | Month | 24 | Day |
Last modified on
| 2025 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066613
