UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047928 |
|---|---|
| Receipt number | R000054635 |
| Scientific Title | Bone mineral density changes from view points of exercise and diet |
| Date of disclosure of the study information | 2022/06/02 |
| Last modified on | 2022/06/02 15:20:03 |
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Basic information
Public title
Bone mineral density changes from view points of exercise and diet
Acronym
Bone mineral density changes from view points of exercise and diet
Scientific Title
Bone mineral density changes from view points of exercise and diet
Scientific Title:Acronym
Bone mineral density changes from view points of exercise and diet
Region
| Japan |
Condition
Condition
adult femalere
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clairfy the effects of home-based resistance training with relatively low repetitions on lumbar spine bone mineral density.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bone mineral density (BMD)
bone mineral contents (BMC)
befor and after 6 months of training period
dietary survey (calcium intake)
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
leg-raise training
3 times per week, 10 times per day
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
| 20 | years-old | < |
Age-upper limit
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
smorking habit
menstrual cycles
medeications use
exercise habits
disorders with pain in back and hip joints
Key exclusion criteria
smorker
irregular menstrual cycles
taking medicine may afect bone metabolismes
regular exercise habits
disorders involving the back and jip joints
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeru |
| Middle name | |
| Last name | Kato |
Organization
Asahi University
Division name
School of Health Sciences
Zip code
501-0296
Address
Mizuho, Hozumi 1851-1
TEL
058-329-1177
t-kato@alice.asahi-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeru |
| Middle name | |
| Last name | Kato |
Organization
Asahi University
Division name
School of Health Sciences
Zip code
501-0296
Address
Mizuho, Hozumi 1851-1
TEL
058-329-1177
Homepage URL
t-kato@alice.asahi-u.ac.jp
Sponsor or person
Institute
Suzuka University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Suzuka University of Medical Science
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
Asahi University
Address
Mizuho, Hozumi 1851-1
Tel
058-329-1177
t-kato@alice.asahi-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
| 2022 | Year | 06 | Month | 02 | 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
18
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
| 2003 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2003 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2004 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 02 | Day |
Last modified on
| 2022 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054635
