UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021042 |
|---|---|
| Receipt number | R000024279 |
| Scientific Title | Effect of exercise training on body mass and body composition |
| Date of disclosure of the study information | 2016/02/16 |
| Last modified on | 2017/08/18 18:10:15 |
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Basic information
Public title
Effect of exercise training on body mass and body composition
Acronym
Exercise and body composition
Scientific Title
Effect of exercise training on body mass and body composition
Scientific Title:Acronym
Exercise and body composition
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the changes of body mass, body water, fat mass, and lean body mass by exercise training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Body water after and before 3 month of exercise training
Key secondary outcomes
Body mass, fat mass, and lean body mass
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise training at aerobic threshold intensity
120 minutes per week
3 month
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy young and middle age men and women
Key exclusion criteria
Contraindication for exercise training
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tobina Takuro |
Organization
University of Nagasaki
Division name
Faculty of nursing and nutrition
Zip code
Address
1-1-1 Manabino, Nagayo-cho, Nishi-Sonogi-gun, Nagasaki
TEL
095-813-5200
tobitaku@sun.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tobina Takuro |
Organization
University of Nagasaki
Division name
Faculty of nursing and nutrition
Zip code
Address
1-1-1 Manabino, Nagayo-cho, Nishi-Sonogi-gun, Nagasaki
TEL
095-813-5200
Homepage URL
tobitaku@sun.ac.jp
Sponsor or person
Institute
University of Nagasaki
Institute
Department
Personal name
Funding Source
Organization
University of Nagasaki
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
長崎県立大学（長崎県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 16 | 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 | 29 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | 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
| 2016 | Year | 02 | Month | 16 | Day |
Last modified on
| 2017 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024279
| 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 |
