UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055315 |
|---|---|
| Receipt number | R000063151 |
| Scientific Title | Investigating the usefulness of sarcopenia assessed using ultrasound images in older orthopaedic patients |
| Date of disclosure of the study information | 2024/08/23 |
| Last modified on | 2025/06/23 19:15:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigating the usefulness of sarcopenia assessed using ultrasound images in older orthopaedic patients
Acronym
Investigating the usefulness of sarcopenia assessed using ultrasound images
Scientific Title
Investigating the usefulness of sarcopenia assessed using ultrasound images in older orthopaedic patients
Scientific Title:Acronym
Investigating the usefulness of sarcopenia assessed using ultrasound images
Region
| Japan |
Condition
Condition
Older orthopaedic patients
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the usefulness of sarcopenia assessed using ultrasound images
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sarcopenia using the ISarcoPRM algorithm on admission and within 3 days postoperatively
Key secondary outcomes
Baseline characteristics, Sarcopenia using the AWGS2019 algorithm, anterior thigh muscle thickness(Sonographic Thigh Adjustment Ratio), anterior thigh muscle intensity, Skeletal Muscle Mass Index, hand grip strength, Knee extension strength, Functional Ambulation Categories, Mini Nutritional Assessment-Short Form,, Mini-Mental State Examination, 5 chair test, gait speed, Timed Up and Go test
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
Older orthopaedic patients (hip fracture, vertebrae compression fracture, total knee arthroplasty)
Key exclusion criteria
Patients who have difficulty in being measured by body composition analyzer, difficulty gait pre-admission, neurological complications, hospitalization of one week or less.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Ikemoto |
Organization
Heisei Memorial Hospital
Division name
Department of Rehabilitation
Zip code
634-0813
Address
827 shijo-cho, kashihara-city, Nara prefecture.
TEL
0744-29-3300
taiki.ikemoto.1202@gmail.com
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Ikemoto |
Organization
Heisei Memorial Hospital
Division name
Department of Rehabilitation
Zip code
634-0813
Address
827 shijo-cho, kashihara-city, Nara prefecture.
TEL
0744-29-3300
Homepage URL
taiki.ikemoto.1202@gmail.com
Sponsor or person
Institute
Heisei Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Heisei Memorial 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
Heisei Memorial Hospital
Address
827 shijo-cho, kashihara-city, Nara prefecture.
Tel
0744-29-3300
taiki.ikemoto.1202@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
| 2024 | Year | 08 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2022 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | 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
Prospective cohort study
Study conducted on older orthopaedic patients admitted to Heisei Memorial Hospital.
Management information
Registered date
| 2024 | Year | 08 | Month | 23 | Day |
Last modified on
| 2025 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063151
