UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039447 |
|---|---|
| Receipt number | R000044978 |
| Scientific Title | Study on the depiction of skeletal muscle function of sarcopenia using diffusion tensor imaging |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2020/02/10 18:27:24 |
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Basic information
Public title
Evaluation of the skeletal muscle function using diffusion tensor imaging
Acronym
Evaluation of the skeletal muscle using diffusion tensor imaging
Scientific Title
Study on the depiction of skeletal muscle function of sarcopenia using diffusion tensor imaging
Scientific Title:Acronym
Evaluation of the skeletal muscle using diffusion tensor imaging
Region
| Japan |
Condition
Condition
sarcopenia
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish morphological and functional evaluation of skeletal muscle using diffusion tensor imaging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The diffusion tensor imaging parameter of skeletal muscle
Key secondary outcomes
SARC-F (Questionnaire)
Lower leg circumference
Grip power
Lower limb muscle strength
Physical ability (walking speed,timed-up-and-go test (TUG) , Chair rise test)
Balance ability (Functional reach test, Standing on single leg)
Body composition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Evaluation of physical function and body composition, and MRI imaging are performed for the sarcopenia group.
Interventions/Control_2
Evaluation of physical function and body composition, and MRI imaging are performed for the non-sarcopenia group.
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
1.Patients in hospital or outpatient of hospital of Kyoto Prefectural University of Medicine, or a person who participated in the Uzumasa physical fitness measurement at Kyoto University of Advanced Science
2.Patients who consent to study participation with the document by free will
3.Patients aged 65 and over at the time of consent acquisition
4.Gender does not matter
[Sarcopenia group:10 people]
1) The lower leg circumference is below the sarcopenia screening standard value by AWGS (Asian Working Group for Sarcopenia) 2019
cut-off value: male<34cm, female<33cm
2)Those who meet the sarcopenia diagnostic criteria by AWGS 2019 (sarcopenia, severe sarcopenia; A+B, A+C, or A+B+C)
A. Low skeletal muscle mass evaluated by Bioelectrical Impedance Analysis
cut-off value:male<7.0kg/m2, female<5.7kg/m2
B. Low muscle strength evaluated by grip power
cut-off value:male<28kg, female<18kg
C. Low physical function evaluated by walking speed
cut-off value<1.0m/s
[Non-sarcopenia group:10 people]
Those who do not meet the above criteria
Key exclusion criteria
1. Pregnant woman
2. Inappropriate MRI imaging
for the following reasons
Pacemaker user
History of cerebral artery clipping
Use non-MRI compatiblemetal implants in the body
Use of metal implant in lower leg
Tattoo and art makeup
Claustrophobia
3. Those who have difficulty assessing motor function for the following reasons
History of myocardial infarction,
symptomatic angina or arrhythmias.
Uncontrolled tachycardia
Uncontrolled hypertension
Symptomatic lung disease
High risk of fracture
Infectious disese
4. Others. The person whom the doctor judged inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Suzuyo |
| Middle name | |
| Last name | Ohashi |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
602-8566
Address
465, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
075-251-5324
reha@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Suzuyo |
| Middle name | |
| Last name | 0hashi |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
602-8566
Address
465, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
075-251-5324
Homepage URL
reha@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Kyoto Prefectural University of Medicine, Clinical Research Review Board
Address
465, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan
Tel
075-251-5111
rinri@koto.kpu-m.ac.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
| 2020 | Year | 03 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 10 | Day |
Last modified on
| 2020 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044978
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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