UMIN-CTR Clinical Trial

Basic information
Public title	Effects of regular Nordic walking on body
Acronym	Effects of Nordic walking on body
Scientific Title	Effects of regular Nordic walking on body
Scientific Title:Acronym	Effects of Nordic walking on body
Region	Japan

Condition
Condition	healthy young women
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to investigate the effects of a 23-week NW program on the bone mineral content and density of the distal radius, and cross-sectional muscle area at the mid-humerus and mid-femur, measured using dual-energy X-ray absorptiometry (DXA) and magnetic resonance imaging (MRI), respectively.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	baseline and after-intervention(23 weeks), height,weight, BMI Bone mineral content, density at distal radius muscle cross-sectional area at mid-humeri, mid-femur, calcium intake,
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	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	at least 30 min with NW poles three times weekly for 23 weeks
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	21 years-old <=
Age-upper limit	26 years-old >=
Gender	Female
Key inclusion criteria	eumenorrheic, non-pregnant, no oral medications, non-smoker, no regular high-impact training, no medical or surgical conditions likely to affect bone metabolism,
Key exclusion criteria	irregular menstruation, pregnant, oral medications likely to affect bone metabolism, regular high-impact training, smoker,
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kato Takeru
Organization	Asahi University
Division name	Department of Health Science and Sport Sciences, School of Health Sciences,
Zip code
Address	1851 Hozumi, Mizuho
TEL	0583291177
Email	t-kato@alice.asahi-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kato Takeru
Organization	Asahi University
Division name	Department of Health Science and Sport Sciences, School of Health Sciences,
Zip code
Address	1851 Hozumi, Mizuho
TEL	0583291177
Homepage URL
Email	t-kato@alice.asahi-u.ac.jp

Sponsor
Institute	Asahi University
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)

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	2018 Year 01 Month 24 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2011 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2012 Year 06 Month 01 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	2018 Year 01 Month 24 Day
Last modified on	2018 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035351

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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