UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of low-repletion jump training on bone mineral density in postmenopausal women
Title of the study (Brief title)	Effects of jumping training on bone
Region	Japan

Condition
Condition	healthy postmenopausal middle-aged women
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to investigate whether low repletion jump training, twice per week are effective for postmenopausal women.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	base-line measurement and after 12 months, Bone mineral contents and density measured by dual energy x-ray absorptiometry. Muscle cross-sectional area at mid-femur, measured by MRI. Calcium intake, Maximum vertical jump height, peak ground reaction force at maximum vertical jump,
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	low-repetition two-footed jump, 20 jumps per day, twice per week, for 12 months,
Interventions/Control_2	control
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	50 years-old <=
Age-upper limit	85 years-old >
Gender	Female
Key inclusion criteria	non-smoker, non-pregnant, no medical or surgical problems likely to affect bone metabolism,
Key exclusion criteria	smoker, pregnant, medical or surgical problems likely to affect bone metabolism,
Target sample size	45

Research contact person
Name of lead principal investigator	Takeru Kato
Organization	Asahi University
Division name	Department of Health Science and Sport Sciences, School of Health Sciences,
Address	1851 Hozumi, Mizuho
TEL	0583291177
Email	t-kato@alice.asahi-u.ac.jp

Public contact
Name of contact person	Takeru Kato
Organization	Asahi University
Division name	Department of Health Science and Sport Sciences, School of Health Sciences,
Address	1851 Hozumi, Mizuho
TEL	0583291177
Homepage URL
Email	t-kato@alice.asahi-u.ac.jp

Sponsor
Institute	Suzuka University of Medical Sciences
Institute
Department

Funding Source
Organization	Ministry of Education, Culture,Sports,Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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	2018 Year 01 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 04 Month 01 Day
Anticipated trial start date	2006 Year 09 Month 01 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 30 Day
Last modified on	2018 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035457