UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056311 |
|---|---|
| Receipt number | R000064340 |
| Scientific Title | Evaluation of the usefulness of skeletal muscle mass assessment using leg muscle thickness in elderly orthopedic outpatients |
| Date of disclosure of the study information | 2024/11/29 |
| Last modified on | 2025/10/04 11:56:40 |
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Basic information
Public title
Evaluation of the usefulness of skeletal muscle mass assessment using leg muscle thickness in elderly orthopedic outpatients
Acronym
Evaluation of the usefulness of skeletal muscle mass assessment using leg muscle thickness in elderly orthopedic outpatients
Scientific Title
Evaluation of the usefulness of skeletal muscle mass assessment using leg muscle thickness in elderly orthopedic outpatients
Scientific Title:Acronym
Evaluation of the usefulness of skeletal muscle mass assessment using leg muscle thickness in elderly orthopedic outpatients
Region
| Japan |
Condition
Condition
elderly orthopedic outpatients.
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate leg muscle thickness using ultrasound echocardiography in elderly orthopedic outpatients and to determine the usefulness of this technique.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. thigh muscle thickness, lower leg muscle thickness, lower leg circumference
2. Motor function: grip strength, knee extension muscle strength, time to stand up 5 times, 5m walking speed
3. locomotive syndrome: rise test, 2-step test, locomo 25
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are attending Michinoo-Miyata Orthopedic clinic and for whom motor rehabilitation is prescribed are eligible.
Key exclusion criteria
Patients who fall into any of the following categories will not be included in this study
(1) Patients with neurological complications or obvious neurological symptoms
(2) Patients with obvious cognitive impairment that makes it difficult to maintain the limb position for measuring skeletal muscle mass or to measure motor function
(3) Patients who require assistance in walking.
(4) Other patients deemed inappropriate as research subjects by the principal investigator.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Ishii |
Organization
Michinoo-Miyata Orthopaedic Clinic
Division name
Department of Rehabilitation
Zip code
8512127
Address
8-2, Koda-go, Nagayo-cho, Nishisonogi-gun, Nagasaki
TEL
0958560001
shunishii331@gmail.com
Public contact
Name of contact person
| 1st name | Shun |
| Middle name | |
| Last name | Ishii |
Organization
Michinoo-Miyata Orthopaedic Clinic
Division name
Department of Rehabilitation
Zip code
8512127
Address
8-2, Koda-go, Nagayo-cho, Nishisonogi-gun, Nagasaki
TEL
0958560001
Homepage URL
shunisii331@gmail.com
Sponsor or person
Institute
Michinoo-Miyata Orthopaedic Clinic
Institute
Department
Personal name
Funding Source
Organization
FRANCE BED HOME CARE FOUNDATION
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
Faculty of Rehabilitation, Kansai Medical University
Address
18-89 Uzanto-cho, Hirakata City, Osaka, Japan
Tel
0728562423
shunishii331@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 | 11 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
42
Results
Thigh quadriceps muscle thickness correlated with functional abilities including grip strength (r=0.53), knee extension strength (r=0.44),
The area under the ROC curve (AUC) for medial gastrocnemius thickness in predicting reduced quadriceps thickness was 0.704 (cutoff value 1.46 cm, sensitivity 0.762, specificity 0.643). Furthermore, the AUC for lower leg circumference was 0.692 (cutoff value 33.5 cm, sensitivity 0.524, specificity 0.714).
Results date posted
| 2025 | Year | 10 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study population comprised 42 participants: 35 women with a mean age of 75.5 years and a mean BMI of 23.2. The conditions for which rehabilitation was prescribed were: spinal disorders in 21 participants, upper limb disorders in 5 participants, and lower limb disorders in 16 participants. Thirty-three participants met the criteria for low skeletal muscle mass using the STAR assessment, and 17 met the criteria for sarcopenia.
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The correlation between thigh muscle thickness, lower leg muscle thickness, and lower leg circumference will be investigated. We will also investigate the relationship between thigh muscle thickness, lower leg muscle thickness, and lower leg circumference and exercise function and locomotive syndrome.
Management information
Registered date
| 2024 | Year | 11 | Month | 29 | Day |
Last modified on
| 2025 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064340
