UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048735 |
|---|---|
| Receipt number | R000055399 |
| Scientific Title | Registry Research on Locomotive Syndrome, Frailty, and Sarcopenia |
| Date of disclosure of the study information | 2022/08/25 |
| Last modified on | 2025/03/07 09:13:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Registry Research on Locomotive Syndrome, Frailty, and Sarcopenia
Acronym
Locomo/Frailty/Sarcopenia Registry
Scientific Title
Registry Research on Locomotive Syndrome, Frailty, and Sarcopenia
Scientific Title:Acronym
Locomo/Frailty/Sarcopenia Registry
Region
| Japan |
Condition
Condition
Locomotive syndrome
Frailty
Sarcopenia
Classification by specialty
| Geriatrics | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The accumulation of evidence based on clinical studies regarding the concepts of locomotive syndrome (Locomo), frailty, and sarcopenia are insufficient in Japan. These three conditions have different backgrounds that led to their advocacy, and it is not easy to organize and properly show the positional relationship between them. In this study, we will establish a disease registry from the viewpoint of frailty in order to conduct clinical research on Locomo, frailty, and sarcopenia for the first time in Japan. Based on the database constructed in this study, we first clarify how often locomotive syndrome and sarcopenia coexist in frail patients, and longitudinal evaluations, hospitalization, institutional admission, certification for long-term care, death, etc. are used as endpoints. By conducting a follow-up survey, the risk of coexistence of frailty, Locomo, and sarcopenia will be clarified, compared to cases where they are present individually. Simultaneously, undernutrition and sensory dysfunction related to these will be evaluated, and the relationship with the above three pathological conditions of frailty, Locomo, and sarcopenia will be clarified.
Basic objectives2
Others
Basic objectives -Others
As longitudinal evaluations, the following items are used as endpoints: hospitalization, institutional admission, certification for long-term care, death, etc.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Death
2. Emergency hospitalization
3. Institutional admission
4. New certification for long-term care and the changes in certification status
5. Fall
6. Fracture caused by a fall
7. Changes in Kihon Checklist
8. Changes in Frailty Screening Index
Key secondary outcomes
State of frailty
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a.
1. Those who can go to the hospital by walking on their own (canes can be used)
2. Those who are frail applicable (based on the following judgment criteria)
3. Those who have consented to participate in the study.
b.
Those who are willing to be examined at the Locomo-Frail Outpatient Clinic and do not fall into the Frail category (control group)
Frail applicable criteria
1. Five or more of the 6 items (meal, urination/defecation control, transferring, going to the toilet, changing clothes, bathing) in the Katz Index, and
2. Those who meet 8 or more points out of the 25 items in the basic checklist
Key exclusion criteria
1. Those who have visual or hearing impairments that interfere with daily life.
2. Those who have obvious paralysis at the time of registration.
3. Those who have already been diagnosed with dementia (including patients taking dementia treatment drugs).
4. Those who have neurological disorders that cause progressive limb dysfunction (Parkinson's disease, for example).
5. Those who are thought to be at the end-of-life stage.
6. Others who are judged to be unsuitable for study registration by a doctor.
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Akatsu |
Organization
National Center for Geriatrics and Gerontology(NCGG)
Division name
Center for Frailty and Locomotive syndrome
Zip code
474-8511
Address
7-430, Morioka-cho, Obu City, Aichi Prefecture, Japan
TEL
0562-46-2311
akatu@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Akatsu |
Organization
National Center for Geriatrics and Gerontology(NCGG)
Division name
Center for Frailty and Locomotive syndrome
Zip code
474-8511
Address
7-430, Morioka-cho, Obu City, Aichi Prefecture, Japan
TEL
0562-46-2311
Homepage URL
akatu@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology(NCGG)
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology(NCGG)
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
Institutional Review Board, National Center for Geriatrics and Gerontology (NCGG).
Address
7-430, Morioka-cho, Obu City, Aichi Prefecture, Japan
Tel
0562-46-2311
yaday@ncgg.go.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
| 2022 | Year | 08 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2036 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Follow-up rate
As of February 14, 2025
1 year later:93%
2 year later:85%
3 year later:77%
Management information
Registered date
| 2022 | Year | 08 | Month | 24 | Day |
Last modified on
| 2025 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055399
