UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047409 |
|---|---|
| Receipt number | R000053951 |
| Scientific Title | Relationship between muscle quality indices by bioelectrical impedance analysis and physical function, and skeletal muscle oxygenation |
| Date of disclosure of the study information | 2022/04/06 |
| Last modified on | 2023/10/07 11:17:26 |
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Basic information
Public title
Relationship between muscle quality indices by bioelectrical impedance analysis and physical function, and skeletal muscle oxygenation
Acronym
Relationship between muscle quality indices by bioelectrical impedance analysis and physical function, and skeletal muscle oxygenation
Scientific Title
Relationship between muscle quality indices by bioelectrical impedance analysis and physical function, and skeletal muscle oxygenation
Scientific Title:Acronym
Relationship between muscle quality indices by bioelectrical impedance analysis and physical function, and skeletal muscle oxygenation
Region
| Japan |
Condition
Condition
Healthy young adults, Hospitalized Patients, Outpatients, Community-dwelling older adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To clarify the relationship between muscle quality indices and skeletal muscle oxygenation, physical function, and exercise performance.
2. The effects of rehabilitation intervention will be clarified from a physiological perspective using indices of muscle quality, physical function, exercise performance, and skeletal muscle oxygenation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Body composition (skeletal muscle mass index, muscle quality score, etc.)
2. Physical function (grip strength, short physical performance battery, 30-second chair stand test, etc.)
3. Exercise performance (6-minute walk test, etc.)
4. Skeletal muscle oxygenation (tissue oxygen saturation, oxyhemoglobin, etc.)
Key secondary outcomes
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Students, patients, and users of educational and medical care institutions participating in the study
Key exclusion criteria
1. Difficulty in holding a standing position for more than 30 seconds
2. Difficulty standing without upper extremity support
3. Difficulty walking
4. Cognitive impairment
5. After pacemaker implantation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiromichi |
| Middle name | |
| Last name | Takeda |
Organization
Kio University Graduate School
Division name
Graduate school of health sciences
Zip code
635-0832
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL
0745-54-1601
hiromichi.takeda0608@gmail.com
Public contact
Name of contact person
| 1st name | Hiromichi |
| Middle name | |
| Last name | Takeda |
Organization
Kio University Graduate School
Division name
Graduate school of health sciences
Zip code
635-0832
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL
0745-54-1601
Homepage URL
hiromichi.takeda0608@gmail.com
Sponsor or person
Institute
Kio University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Kio University Graduate School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University Graduate School
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, Japan
Tel
0745-54-1601
hiromichi.takeda0608@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
| 2022 | Year | 04 | Month | 06 | 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
| 2022 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Cohort study
Methods of recruitment of subjects:.
Patients and users who received rehabilitation at participating facilities in this study from April 2022 to March 2024. Students at participating facilities in this study.
Outcomes are measured at the beginning and end of rehabilitation.
Management information
Registered date
| 2022 | Year | 04 | Month | 06 | Day |
Last modified on
| 2023 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053951
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
