UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057442 |
|---|---|
| Receipt number | R000065632 |
| Scientific Title | Grip strength as a simple method for sarcopenia screening to predict postoperative delirium after lower extremity surgery in elderly: a prospective diagnostic evaluation |
| Date of disclosure of the study information | 2025/03/28 |
| Last modified on | 2025/03/28 20:15:32 |
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Basic information
Public title
Grip strength as a simple method for sarcopenia screening to predict postoperative delirium after lower extremity surgery in elderly: a prospective diagnostic evaluation
Acronym
Grip strength for postoperative delirium prediction
Scientific Title
Grip strength as a simple method for sarcopenia screening to predict postoperative delirium after lower extremity surgery in elderly: a prospective diagnostic evaluation
Scientific Title:Acronym
Grip strength for postoperative delirium prediction
Region
| Asia(except Japan) |
Condition
Condition
Elderly patients underwent lower extremity surgery
Classification by specialty
| Geriatrics | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
this study aims to investigate whether grip strength (GS) by itself can serve as a useful predictor of postoperative delirium (POD) in this patient population.
Basic objectives2
Others
Basic objectives -Others
diagnostic evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of Post-anesthetic care unit Delirium assessed by CAM-ICU, and its association with low grip strength
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged over 65 years who were scheduled for lower extremity surgery under general anesthesia and had no preoperative cognitive dysfunction were eligible
Key exclusion criteria
hemodynamic instability, intellectual disability, or refusal to participate
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Seok Kyeong |
| Middle name | |
| Last name | Oh |
Organization
Korea University Guro Hospital
Division name
Seoul
Zip code
08308
Address
148, Gurodong-ro
TEL
82-2-2626-3234
nanprayboy@korea.ac.kr
Public contact
Name of contact person
| 1st name | Seok Kyeong |
| Middle name | |
| Last name | Oh |
Organization
Korea University Guro Hospital
Division name
Seoul
Zip code
08308
Address
148, Gurodong-ro
TEL
82-2-2626-3234
Homepage URL
nanprayboy@korea.ac.kr
Sponsor or person
Institute
Korean Society of Geriatric Anesthesia and Pain
Institute
Department
Personal name
Funding Source
Organization
Korean Society of Geriatric Anesthesia and Pain
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
Korea University Guro Hospital
Address
148, Gurodong-ro
Tel
82-2-2626-1635
nanprayboy@korea.ac.kr
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 | 03 | Month | 28 | Day |
Related information
URL releasing protocol
https://kiris.kumc.or.kr/
Publication of results
Unpublished
Result
URL related to results and publications
https://kiris.kumc.or.kr/
Number of participants that the trial has enrolled
150
Results
GS of 150 patients median aged 73 years was evaluated. POD was diagnosed in 17 patients, 13 of whom had low GS. Among the four sarcopenia criteria, the AWGS showed the highest area under ROC curve 0.796. Of the variables analyzed, including age, ASA class, body weight, intraoperative opioid, and postoperative pain, only low GS was identified as an independent predictor of POD.
Results date posted
| 2025 | Year | 03 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
GS of 150 patients median aged 73 years was evaluated. POD was diagnosed in 17 patients, 13 of whom had low GS. Among the four sarcopenia criteria, the AWGS showed the highest area under ROC curve 0.796. Of the variables analyzed, including age, ASA class, body weight, intraoperative opioid, and postoperative pain, only low GS was identified as an independent predictor of POD.
Participant flow
This prospective study included patients aged >65 years undergoing lower extremity surgery. Preoperative GS was measured, and sarcopenia was diagnosed using the Asian Working Group for Sarcopenia (AWGS) criteria and three others. POD was assessed with the Confusion Assessment Method for the ICU (CAM-ICU). Receiver operating characteristic (ROC) curves were used evaluate the sensitivity and specificity of low GS in predicting POD. Logistic regression analysis was performed to identify variables independently associated with POD incidence.
Adverse events
None
Outcome measures
This prospective study included patients aged >65 years undergoing lower extremity surgery. Preoperative GS was measured, and sarcopenia was diagnosed using the Asian Working Group for Sarcopenia (AWGS) criteria and three others. POD was assessed with the Confusion Assessment Method for the ICU (CAM-ICU). Receiver operating characteristic (ROC) curves were used evaluate the sensitivity and specificity of low GS in predicting POD. Logistic regression analysis was performed to identify variables independently associated with POD incidence.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 21 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 21 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 22 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 16 | Day |
Other
Other related information
GS is a simple and reliable tool for diagnosing sarcopenia and may serve as an independent predictor of POD in elderly undergoing lower extremity surgery.
Management information
Registered date
| 2025 | Year | 03 | Month | 28 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065632
