UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021579 |
|---|---|
| Receipt number | R000024878 |
| Scientific Title | Effect of different exercise prescription on bone metabolism |
| Date of disclosure of the study information | 2016/03/23 |
| Last modified on | 2017/04/29 16:43:07 |
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Basic information
Public title
Effect of different exercise prescription on bone metabolism
Acronym
Effect of different exercise prescription on bone metabolism
Scientific Title
Effect of different exercise prescription on bone metabolism
Scientific Title:Acronym
Effect of different exercise prescription on bone metabolism
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to assess the acute effects of different exercise prescription schemes (intensity/duration) on bone metabolism in young adult women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
serum markers of bone metabolism
Key secondary outcomes
exercise intensity
exercise duration
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
No exercise
Interventions/Control_2
Continuous exercise at moderate intensity
Interventions/Control_3
Continuous exercise below moderate intensity
Interventions/Control_4
Intermittent exercise at moderate intensity (for some subjects but not all of the subjects who participated)
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
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy adult women who are between 20 and 45 years of age and reported regular (normal) menstrual cycles without exercise habits
Key exclusion criteria
People who have concomitant diseases/injuries affecting enforcement of safety physical exercise, including 1) abnormalities on the resting electrocardiogram, 2) with a history of cardiovascular disease including recent myocardial infarction, 3) severe lever or kidney diseases, 4) hypertension or diabetes mellitus, 5) a person who is scheduled to have an operation (surgery),and 6) a patient who is recovering/treatment from/in other serious diseases.
7) Gynopathy related to abnormalities on the bone metabolism
8) During pregnancy and within 1 year postpartum
9) person who has a fracture within one year
10) Person who uses oral contraceptives and other steroid drugs
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Kumahara |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
Address
5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan
TEL
092-851-2531
kumahara-h@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Kumahara |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
Address
5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan
TEL
092-851-2531
Homepage URL
kumahara-h@umin.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 23 | 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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 23 | Day |
Last modified on
| 2017 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024878
| 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 |
