UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051092 |
|---|---|
| Receipt number | R000058267 |
| Scientific Title | An observational study of locomotor system in Japanese middle-aged and older men and women |
| Date of disclosure of the study information | 2023/05/18 |
| Last modified on | 2023/11/17 09:37:10 |
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Basic information
Public title
An observational study of locomotor system in Japanese middle-aged and older men and women
Acronym
An observational study of locomotor system in Japanese middle-aged and older men and women
Scientific Title
An observational study of locomotor system in Japanese middle-aged and older men and women
Scientific Title:Acronym
An observational study of locomotor system in Japanese middle-aged and older men and women
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to conduct a cross-sectional observational study to explore the relationship between locomotor system and aging in middle-aged and older men and women who experience a decline in walking function and muscle strength.
Basic objectives2
Others
Basic objectives -Others
Collection of cohort data
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Body composition, CT of femur region, physical function tests, quality of life survey, dietary survey
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese men and women between 40 and under 80 years of age at the time of consent
2. Subjects who experience a decline in walking function and muscle strength
Key exclusion criteria
1. Subjects who are undergoing treatment for diseases related to the locomotor system, or subjects who have sequelae due to a history of such diseases
2. Subjects who have undergone joint replacement surgery or intra-articular injections of hyaluronic acid, steroids within 3 months of the date consent was obtained
3. Subjects who had a bone fracture within 1 year prior to obtaining consent to participate in this study
4. Subjects with bruises or sprains within 3 months prior to obtaining consent to participate in this study
5. Subjects who have been diagnosed with a cancer, subjects who are under treatment for or have a history of diseases such as brain, heart, renal, or psychiatric diseases, diabetes, thyroid dysfunction, or diseases that affect the secretion of adrenal cortical hormones, or subjects who have a history of serious diseases such as liver disease
6. Patients undergoing treatment for hypertension, unless the investigational doctor determines that there are no safety issues
7. who have been diagnosed with or are under treatment for cognitive dysfunction
8. Subjects who routinely use prescription drugs or over-the-counter drugs for more than 3 days per week.
9. Subjects who are engaged in strenuous physical activities that put stress on joints and muscles. 10. Subjects who are using a cane or supporter.
11. Subjects who regularly perform activities that may affect joints and muscles, such as massage, spa, bodywork, etc.
12. Subjects who have a cardiac pacemaker or other precision device implanted in their body.
13. Subjects who are heavy drinkers of alcohol
14. Subjects who have participated in other clinical studies within one month prior to obtaining consent to participate in this study, or who will participate in other clinical studies after obtaining consent to participate in this study
15. Subjects who intend to become pregnant or lactating
16. Subjects judged as unsuitable for the study by the investigational doctor for other reasons
Target sample size
324
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Matsuoka |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
244-0806
Address
12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa ,Japan
TEL
045-820-3755
matsuoka@fancl.co.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Ueda |
Organization
EP Mediate Co., Ltd.
Division name
Foods Department, Trial Planning Section 2
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8, Tsukudo-cho, Shinjuku-ku, Tokyo
TEL
080-8044-2432
Homepage URL
ueda.noriko730@eps.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.co.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
社会福祉法人新栄会 滝野川病院（東京都）、医療法人社団つむぎ会 守島医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 18 | 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
324
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
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Observational / cross-sectional studies
Management information
Registered date
| 2023 | Year | 05 | Month | 18 | Day |
Last modified on
| 2023 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058267
| 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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