UMIN-CTR Clinical Trial

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
Email	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
Email	t-kato@alice.asahi-u.ac.jp

Sponsor
Institute	Suzuka University of Medical Science
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054635