UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055886 |
|---|---|
| Receipt number | R000063497 |
| Scientific Title | Exploratory Study on the Evaluation of Sarcopenia Using Electrical Impedance Tomography |
| Date of disclosure of the study information | 2024/10/20 |
| Last modified on | 2024/10/20 03:21:31 |
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Basic information
Public title
Exploratory Study on the Evaluation of Sarcopenia Using Electrical Impedance Tomography
Acronym
Exploratory Study on the Evaluation of Sarcopenia Using Electrical Impedance Tomography
Scientific Title
Exploratory Study on the Evaluation of Sarcopenia Using Electrical Impedance Tomography
Scientific Title:Acronym
Exploratory Study on the Evaluation of Sarcopenia Using Electrical Impedance Tomography
Region
| Japan |
Condition
Condition
The event is open to anyone, regardless of the type of disease
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(i) to assess whether the EIT method is an alternative method for the diagnosis of sarcopenia
(ii) to clarify whether the EIT method can assess sarcopenia longitudinally.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences between sarcopenia classification and muscle mass assessment using the EIT method.
Key secondary outcomes
Relationship between muscle activity and motor function via EIT method, measurement of upper and lower limb morphology, and daily living activities
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients visiting the Department of Plastic and Aesthetic Surgery and the Outpatient Department of the Geriatric Medical Centre at Chiba University Hospital
2) Patients aged 18 years or older at the time of consent.
3) Patients who are able to walk 15 m.
4) Patients who have been fully informed about their participation in the study and have given their free written consent with full understanding.
Key exclusion criteria
1) Pregnant women, lactating women and women who wish to become pregnant during the treatment period.
2) Other patients deemed by the principal investigator to be unsuitable to participate in the study.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Mitsukawa |
Organization
Graduate school of Medicine, Chiba University
Division name
Department of Plastic Surgeon
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
nmitsu@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yukie |
| Middle name | |
| Last name | Tahara |
Organization
Graduate school of nursing, Chiba University
Division name
Department of Health Promotion in Nursing and Midwifery
Zip code
260-8672
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-226-2781
Homepage URL
taharayk@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital, Clinical Research Center
Address
1-8-1 Inohoana, Chuo-ku, Chiba, Chiba
Tel
043-226-2734
prc-jim@chiba-u.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
| 2024 | Year | 10 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study utilizes Electrical Impedance Tomography (EIT) method, consisting of wearable sensors, a compact measurement unit, and cloud computing, to explore its correlation with sarcopenia diagnosis, which involves assessments of grip strength and physical function. Measurements using the developed EIT device are conducted on patients visiting research facilities, and the results are analyzed. Additionally, the study evaluates the utility of longitudinal EIT assessments in patients with Werner syndrome, a condition characterized by accelerated aging. The objectives of this research are: 1) To evaluate whether the EIT method can serve as an alternative approach for diagnosing sarcopenia, and 2) To determine whether the EIT method can longitudinally assess sarcopenia. The study design includes a cross-sectional study for objective 1 and a prospective cohort study for objective 2. Objective 1 includes participants without specifying the type of disease, whereas objective 2 specifically targets patients with Werner syndrome. Recruitment is conducted from December 2023 to March 2028 among those visiting the research facilities. The data collected includes basic demographic information such as age and gender, body composition through impedance measurements, physical function assessments such as the Short Physical Performance Battery, degree of limb edema through ultrasound, and daily living evaluations using questionnaires like the Barthel index and wearable devices.
Management information
Registered date
| 2024 | Year | 10 | Month | 20 | Day |
Last modified on
| 2024 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063497
