UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030567 |
|---|---|
| Receipt number | R000034899 |
| Scientific Title | Research on influence of Locomotive Syndrome relating indicator effected by daily living |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2024/01/22 14:32:55 |
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Basic information
Public title
Research on influence of Locomotive Syndrome relating indicator effected by daily living
Acronym
Research on influence of Locomotive Syndrome relating indicator effected by daily living
Scientific Title
Research on influence of Locomotive Syndrome relating indicator effected by daily living
Scientific Title:Acronym
Research on influence of Locomotive Syndrome relating indicator effected by daily living
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The senior citizens who have difficulties of exercise are examined in this study, we exploratory study about the effect how the combination use of direction of exercise and taking high protein food containing lactic acid bacteria protein
help them to increase the chance of exercise and to decrease the ratio of locomotive syndrome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of indicators related locomotive-syndrome by comparing with 'only exercise' and 'exercise and foods containing lactic acid bacteria protein'.
Key secondary outcomes
Construct evidence of intervention effect on LOCOMO
Collection of basic data in LOCOMO research
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
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Exercise instruction and high-protein food containing lactic acid bacteria Group
Interventions/Control_2
Exercise Instruction Group
Interventions/Control_3
Control Group
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<Subject>
Volunteers who wish to participate in LOCOMO enlightenment activities tackled by facilities participating in this research
<Selection Criteria>
1. Volunteers are 20 years of age or older at the time of consent acquisition
2. Volunteers who were confirmed about exerciser disease and other past medical history and had no obstacle to motor function
3. Volunteers who obtain documents consent by free will after sufficient understandings as receiving the sufficient explanation upon participation in this research.
Key exclusion criteria
1. Volunteers who are not be able to obtain consent from the principal about using data in this research
2. Volunteers who are not able to walk independently
3. Volunteers who are not able to fill out questionnaire by themselves
4. Volunteers who are not able to fully understand the instruction and explanation of the examiner
5. Others.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Etsuo |
| Middle name | |
| Last name | Chosa |
Organization
University of Miyazaki
Division name
Department of Orthopaedic Surgery, faculty of medicine
Zip code
889-1692
Address
5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
TEL
0985-85-0986
seikei@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Etsuo |
| Middle name | |
| Last name | Chosa |
Organization
University of Miyazaki
Division name
Department of Orthopaedic Surgery, faculty of medicine
Zip code
889-1692
Address
5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
TEL
0985-85-0986
Homepage URL
seikei@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
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
Clinical Research Support Center
Address
5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
Tel
0985-85-9403
igakubu_kenkyu@med.miyazaki-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
| 2018 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
245
Results
To avoid locomotive syndrome in elderly people with decreased motor function, training improves the amount of exercise and locomotive related index, and intake of test food suppresses muscle mass loss.
Results date posted
| 2023 | Year | 10 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Those who wish to participate will be asked to complete the five items related to motor function from the "Basic Checklist" recommended by the Ministry of Health, Labor and Welfare. Screened subjects who are considered to have decreased motor function with a score of 3 or higher. Scores of less than 2 points were excluded.
Participant flow
1) Implementation of basic checklist
2) Participant allocation
3) First measurement (0M)
4) Research period (3 months)
5) Measurement after 3 months (3M)
6) Survey after 1 year of research participation
Adverse events
none
Outcome measures
Locomotive related indicators
1) Body composition (weight, muscle mass, body fat, water content)
2) Locomotive degree test (rise test, 2-step test, locomotive 25)
3) Loco check
4) Stand up from the chair
5) Standing on one leg with eyes open
6) Grip strength
7) SF-8 (Health-related QOL scale: physical function, social function, etc.)
8) Blood test items (25OH vitamin D, high sensitivity CRP)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
This if for Construct evidence of intervention effect on LOCOMO and collection of basic data in LOCOMO research
Management information
Registered date
| 2017 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034899
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