UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045696 |
|---|---|
| Receipt number | R000052145 |
| Scientific Title | The Effect of Postoperative Grip Strength on Frailty, Falls, and Mortality in Hip Fracture Patients One Year Later |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2021/10/07 17:40:08 |
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Basic information
Public title
The Effect of Postoperative Grip Strength on Frailty, Falls, and Mortality in Hip Fracture Patients One Year Later
Acronym
The Effect of Postoperative Grip Strength on Frailty, Falls, and Mortality in Hip Fracture Patients One Year Later
Scientific Title
The Effect of Postoperative Grip Strength on Frailty, Falls, and Mortality in Hip Fracture Patients One Year Later
Scientific Title:Acronym
The Effect of Postoperative Grip Strength on Frailty, Falls, and Mortality in Hip Fracture Patients One Year Later
Region
| Japan |
Condition
Condition
hip fractures
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to investigate postoperative grip strength and 1-year postoperative outcomes to test the hypothesis that postoperative grip strength influences frailty, falls and mortality.
Basic objectives2
Others
Basic objectives -Others
cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical Frailty index, falls, mortality, and days until death at 1 year postoperatively
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Able to measure grip strength
Key exclusion criteria
Unable to obtain consent for research
Died during hospitalization and was discharged
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yota |
| Middle name | |
| Last name | Yamazaki |
Organization
Shizuoka City Shimizu Hospital
Division name
Department of Rehabilitation Technology
Zip code
4240055
Address
+81543361111
TEL
+81543361111
18mr08@g.seirei.ac.jp
Public contact
Name of contact person
| 1st name | Yota |
| Middle name | |
| Last name | Yamazaki |
Organization
Shizuoka City Shimizu Hospital
Division name
Department of Rehabilitation Technology
Zip code
4240055
Address
1231 Miyakami, Shimizu-Ku, Shizuoka, Shizuoka, Japan
TEL
+81543361111
Homepage URL
18mr08@g.seirei.ac.jp
Sponsor or person
Institute
Shizuoka City Shimizu Hospital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka City Shimizu Hospital
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
Shizuoka City Shimizu Hospital Research Ethics Committee
Address
1231 Miyakami, Shimizu-Ku, Shizuoka, Shizuoka, Japan
Tel
+81543361111
smz-hsp-soumu@city.shizuoka.lg.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
| 2022 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will review progress on a yearly basis and make any necessary revisions.
Management information
Registered date
| 2021 | Year | 10 | Month | 07 | Day |
Last modified on
| 2021 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052145
