UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050173 |
|---|---|
| Receipt number | R000057149 |
| Scientific Title | Quantitative and qualitative changes in the submandibular muscles in elderly patients after hip fracture surgery: an ultrasound imaging study. |
| Date of disclosure of the study information | 2023/01/30 |
| Last modified on | 2024/03/03 20:27:08 |
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Basic information
Public title
Quantitative and qualitative changes in the submandibular muscles in elderly patients after hip fracture surgery: an ultrasound imaging study.
Acronym
Ultrasound imaging study of swallowing muscle changes after hip fracture surgery
Scientific Title
Quantitative and qualitative changes in the submandibular muscles in elderly patients after hip fracture surgery: an ultrasound imaging study.
Scientific Title:Acronym
Ultrasound imaging study of swallowing muscle changes after hip fracture surgery
Region
| Japan |
Condition
Condition
Hip fracture
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observe changes in swallowing muscles and systemic skeletal muscles after hip fracture surgery to identify differences in change.
Basic objectives2
Others
Basic objectives -Others
The relationship between swallowing function and muscle changes will be clarified.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area and quality of swallowing and skeletal muscle (immediately after surgery and 2 weeks later)
Locomotion of swallowing muscles (immediately after surgery and 2 weeks later)
Key secondary outcomes
Age, nutritional status, inflammatory response level, skeletal muscle mass, grip strength, physical function (Barthel Index), tongue pressure, presence of complications, surgical technique, delirium
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
Postoperative patients over 65 years of age with hip fracture
Persons with research consent
Key exclusion criteria
1. Patients who could not give consent for the study
2. Patients who had difficulty performing the measurement items.
3. Patients with preexisting conditions involving organic changes in the swallowing muscles (postoperative tongue cancer, postoperative cancer in the head and neck region)
Patients who meet at least one of the exclusion criteria will be excluded.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Yuto |
| Middle name | |
| Last name | Kiyomiya |
Organization
Seireisakura Citizen hospital
Division name
Rehabilitation Department
Zip code
285-0825
Address
2-36-2 Eharadai, Sakura-shi, Chiba
TEL
043-486-1151
to.yu.yamiyoki.2525@gmail.com
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Kiyomiya |
Organization
Seireisakura Citizen hospital
Division name
Rehabilitation Department
Zip code
285-0825
Address
2-36-2 Eharadai, Sakura-shi, Chiba
TEL
043-486-1151
Homepage URL
to.yu.yamiyoki.2525@gmail.com
Sponsor or person
Institute
Seireisakura citizen hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Seireisakura citizen hospital
Address
2-36-2 Eharadai, Sakura-shi, Chiba
Tel
0434861151
to.yu.yamiyoki.2525@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
| 2023 | Year | 01 | Month | 30 | 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
52
Results
52(mean age 85.8)
Postoperative changes were observed in the cross sectional area and muscle brightness of the geniohyoid and digastric muscles, and the degree of change varied depending on the muscle. In patients with a large decrease in the cross sectional area of the geniohyoid muscle, muscle contraction worsened 2 weeks after surgery. Patients with dysphagia were in a state of sarcopenia, and the cross sectional area of the digastric muscle was decreased.
Results date posted
| 2024 | Year | 03 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients were admitted to the Orthopedic Department of Seirei Sakura City Hospital from January to October 2023 and underwent surgery for proximal femoral fractures. Exclusion criteria were patients with a history of organic changes in the geniohyoid muscle, patients who could not be evaluated within 48 hours of admission, and patients who underwent feeding and swallowing rehabilitation over time.
Participant flow
Ultrasound evaluation was performed at two time points: within 3 days and 2 weeks after surgery. Three measurement sites were measured: the cross-sectional area of the geniohyoid muscle, the anterior belly of the digastric muscle, and the anterior upper arm.
To evaluate swallowing function, patients drank 3 ml, 10 ml, and 100 ml of water 2 weeks after surgery. Based on the results, they were classified into a ``dysphagia group'' and a ``healthy group.''
Adverse events
Nothing in particular.
Outcome measures
Study I: Geniohyoid muscle cross-sectional area, digastric muscle anterior belly, anterior humerus
Study II: Shortening rate of geniohyoid muscle
Study III: Age, BMI (body mass index), lower leg circumference, grip strength, tongue pressure, prealbumin level, C-reactive protein (CRP), BI (Barthel Index), FILS (Food Intake LEVEL Scale), geniohyoid bone Muscle cross-sectional area, muscle brightness, shortening rate, anterior brachial muscle thickness, digastric muscle cross-sectional area, muscle brightness
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Swallowing muscles, skeletal muscles, age and nutritional indices, inflammatory response values, grip strength, physical function (Barthel Index), tongue pressure, presence of complications, surgical technique, delirium
Management information
Registered date
| 2023 | Year | 01 | Month | 29 | Day |
Last modified on
| 2024 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057149
