UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036251 |
|---|---|
| Receipt number | R000041288 |
| Scientific Title | What is the physiological characteristic of extramyocellular lipid responsible for the muscle quality in older individuals? |
| Date of disclosure of the study information | 2019/04/15 |
| Last modified on | 2023/02/06 09:35:25 |
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Basic information
Public title
What is the physiological characteristic of extramyocellular lipid responsible for the muscle quality in older individuals?
Acronym
What is the physiological characteristic of extramyocellular lipid responsible for the muscle quality in older individuals?
Scientific Title
What is the physiological characteristic of extramyocellular lipid responsible for the muscle quality in older individuals?
Scientific Title:Acronym
What is the physiological characteristic of extramyocellular lipid responsible for the muscle quality in older individuals?
Region
| Japan |
Condition
Condition
Healthy persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of our study is to access physiological characteristics of extramyocellular lipid in human
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationships among extramyocellular lipid, cytokine, muscle functions, body compositions and daily physical activity
Key secondary outcomes
Change of extramyocellular lipid after muscle contraction induced by electrical stimulation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Muscle contraction induced by electrical stimulation
Interventions/Control_2
Control
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
Adults with necessary to nursing care, contraindication of MRI and restriction of exercise
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Teruhiko |
| Middle name | |
| Last name | Koike |
Organization
Nagoya University
Division name
Graduate School of Medicine/ Research Center of Health Physical Fitness and Sports
Zip code
4648601
Address
Furo-cho, Chikusa-ku, Nagoya, Aichi
TEL
0527893946
koike@htc.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | Ishiguro |
| Last name | Tanaka |
Organization
Nagoya University
Division name
Research Center of Health Physical Fitness and Sports
Zip code
4648601
Address
Furo-cho, Chikusa-ku, Nagoya, Aichi
TEL
0527893946
Homepage URL
tanaka-n@htc.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya 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
Chukyo University, Japan Institute of Sports Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of Nagoya University Graduate School of Medicine.
Address
65, Tsurumai-cho, syowa-ku, Nagoya, Aichi
Tel
0527442423
ethics@med.nagoya-u.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
| 2019 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000041288
Publication of results
Published
Result
URL related to results and publications
https://physoc.onlinelibrary.wiley.com/doi/10.14814/phy2.15236, https://cdnsciencepub.com/doi/10.113
Number of participants that the trial has enrolled
32
Results
We set two purposes; (1) to investigate the related parameter with extremyocellular lipid (EMCL) and 2) to investigate the effect of neuromusuclar electrical stimulation (NMES) on EMCL. We found that muscle quality and quantity was related with EMCL. Furthermore, EMCL did not change after NMES.
Results date posted
| 2022 | Year | 09 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Older individuals
Participant flow
Thirty-two older individuals were participated in this study. They assigned NMES group (n=24) and Control group (n=8) with non-randamized controlled trial.
Adverse events
None
Outcome measures
height, body mass, body composition, intramyocellular lipid, extramyocellular lipid, maximal knee extension torque, physical function tests, muscle thickness, muscle echo intensity, blood biochemistry
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 03 | Month | 19 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041288
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