UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042759 |
|---|---|
| Receipt number | R000048797 |
| Scientific Title | Development of the locomotive syndrome preventive exercise program for healthy subjects |
| Date of disclosure of the study information | 2021/01/01 |
| Last modified on | 2020/12/15 17:21:10 |
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Basic information
Public title
Development of the locomotive syndrome preventive exercise program for healthy subjects
Acronym
Development of the locomotive syndrome preventive exercise program
Scientific Title
Development of the locomotive syndrome preventive exercise program for healthy subjects
Scientific Title:Acronym
Development of the locomotive syndrome preventive exercise program
Region
| Japan |
Condition
Condition
Sarcopenia, Locomotive Syndrome, Frailty
Classification by specialty
| Geriatrics | Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of the exercise program aimed at increase of skeletal muscle mass
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle mass which evaluated 12 weeks after intervention start
Key secondary outcomes
Muscle strength, physical function, body composition, blood parameters, cognitive function which evaluated 12 weeks after intervention start
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Exercise program which was conducted twice a week for 12 weeks
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy
Key exclusion criteria
Exercise is forbidden by a doctor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Machida |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1 Hiraka-gakuendai, Inzai-shi, Chiba, JAPAN
TEL
0476-98-1001
machidas@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shuichi |
| Middle name | |
| Last name | Machida |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1 Hiraka-gakuendai, Inzai-shi, Chiba, JAPAN
TEL
0476-98-1001
Homepage URL
machidas@juntendo.ac.jp
Sponsor or person
Institute
Japan Science and Technology Agency
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Ethics committee in Juntendo University Graduate School of Health and Sports Science
Address
1-1 Hiraka-gakuendai, Inzai-shi, Chiba, JAPAN
Tel
0476-98-1001
sc-gradkyomu@juntendo.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
| 2021 | Year | 01 | Month | 01 | 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
| 2015 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 12 | Month | 15 | Day |
Last modified on
| 2020 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048797
