UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060896 |
|---|---|
| Receipt number | R000069682 |
| Scientific Title | Progression of Physical Function and Implementation Status of Acute-Phase Mobilization Programs in Hospitalized Older Patients with Heart Failure |
| Date of disclosure of the study information | 2026/03/11 |
| Last modified on | 2026/03/11 12:25:08 |
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Basic information
Public title
Physical Function in Hospitalized Older Patients with Heart Failure
Acronym
Physical Function in Older Patients with Heart Failure
Scientific Title
Progression of Physical Function and Implementation Status of Acute-Phase Mobilization Programs in Hospitalized Older Patients with Heart Failure
Scientific Title:Acronym
Progression of Physical Function and Implementation Status of Acute-Phase Mobilization Programs in Hospitalized Older Patients with Heart Failure
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To identify characteristics of older heart failure patients requiring hospitalization who failed to reach the final stage of the acute mobilization program
2. To clarify the course of inpatient rehabilitation and physical function in patients who failed to reach the final stage of the acute mobilization program
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Final Stage of the Acute Phase Ambulation Program for Patients with Acute Heart Failure
Key secondary outcomes
Physical Functions: SPPB, Grip Strength
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age 65 or older at the time of hospitalization
2. Individuals hospitalized for heart failure between the date of hospital director approval and November 30, 2026, who underwent an acute-phase mobilization program under a prescription for cardiac rehabilitation
Key exclusion criteria
1. Death during hospitalization
2. Significant cognitive decline
3. Bedridden status prior to hospitalization
4. Patients requiring invasive treatment during hospitalization (e.g., various catheter procedures, invasive mechanical ventilation)
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Kozu |
Organization
Nagasaki University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7963
ryokozu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Kozu |
Organization
Nagasaki University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7963
Homepage URL
ryokozu@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Ethics Review Committee of the Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7726
ryokozu@nagasaki-u.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 11 | 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
| 2025 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 15 | 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
N/A
Management information
Registered date
| 2026 | Year | 03 | Month | 11 | Day |
Last modified on
| 2026 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069682
