UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059636 |
|---|---|
| Receipt number | R000068021 |
| Scientific Title | Impact of cognitive impairment on postoperative quality of life in patients with hip fractures |
| Date of disclosure of the study information | 2025/11/04 |
| Last modified on | 2025/11/04 17:45:27 |
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Basic information
Public title
Impact of cognitive impairment on postoperative quality of life in patients with hip fractures
Acronym
Impact of cognitive impairment on postoperative quality of life in patients with hip fractures
Scientific Title
Impact of cognitive impairment on postoperative quality of life in patients with hip fractures
Scientific Title:Acronym
Impact of cognitive impairment on postoperative quality of life in patients with hip fractures
Region
| Japan |
Condition
Condition
hip fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The impact of cognitive impairment on postoperative quality of life was examined in hip fracture patients aged 80 years or older.
Basic objectives2
Others
Basic objectives -Others
The impact of cognitive impairment on postoperative quality of life was examined in hip fracture patients aged 80 years or older.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EQ-5D-5L
Key secondary outcomes
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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients 80 years of age or older undergoing hip surgery
Key exclusion criteria
Those unable to hear from family members, supporters, or the patient himself/herself about the patient's ADL status prior to the fracture
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Kamimura |
Organization
Shinshu University
Division name
School of Health Sciences
Zip code
3908621
Address
3-1-1 Asahi Matsumoto, Japan
TEL
0263372395
tkamimu@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kamimura |
Organization
Shinshu University
Division name
School of Health Sciences
Zip code
3900303
Address
3-1-1 Asahi Mastumoto Japan
TEL
0263372395
Homepage URL
tkamimu@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Shinshu University Medical Ethics Committee
Address
3-1-1 Asahi Matsumoto Japan
Tel
0263-37-2572
mdrinri@shinshu-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
| 2025 | Year | 11 | Month | 04 | 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
368
Results
The EQ-5D-5L was used to examine QOL recovery at 1, 3, 6, and 12 months after hip fracture surgery in patients over 80 years old (mean 88.6, SD 4.9 years). This study revealed that QOL recovery differed according to the severity of cognitive impairment of the patients.
Results date posted
| 2025 | Year | 11 | Month | 04 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Dissertation in progress
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
| 2021 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 11 | Month | 04 | Day |
Last modified on
| 2025 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068021
