UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of different exercise prescription on bone metabolism
Title of the study (Brief title)	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	Hideaki Kumahara
Organization	Nakamura Gakuen University
Division name	Faculty of Nutritional Sciences
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	Hideaki Kumahara
Organization	Nakamura Gakuen University
Division name	Faculty of Nutritional Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000024878