UMIN-CTR Clinical Trial

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
Email	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
Email	reha@koto.kpu-m.ac.jp

Sponsor
Institute	Department of Rehabilitation Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044978