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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021579
Receipt No. 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

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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
Email 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
Email kumahara-h@umin.ac.jp

Sponsor
Institute Nakamura Gakuen University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024878

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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