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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000006109
Receipt No. R000007228
Scientific Title Verification of effects of interval walking training (IWT) on microcirculation dynamics
Date of disclosure of the study information 2014/07/08
Last modified on 2014/07/08

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Basic information
Public title Verification of effects of interval walking training (IWT) on microcirculation dynamics
Acronym A change in microcirculation dynamics
after IWT
Scientific Title Verification of effects of interval walking training (IWT) on microcirculation dynamics
Scientific Title:Acronym A change in microcirculation dynamics
after IWT
Region
Japan

Condition
Condition lifestyle-related diseases
Classification by specialty
Cardiology Geriatrics Ophthalmology
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the present study is to examine effects of IWT on microcirculation dynamics in gingival area and fundus of the eye.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in gingival blood flow and a diameter of fundal blood vessels after 12-week IWT.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group: IWT, repeated walking at 70% VO2eak and 40% VO2peak, over 30 min per day and 4 days per week for 12 weeks.
Interventions/Control_2 Non-intervention group: no intervention
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

Not applicable
Gender Male and Female
Key inclusion criteria People
1) whose systolic blood pressure is less than 159 mmHg and diastolic blood pressure is less than 99 mmHg,
2) who have no previous medical histories interfering with IWT,
3) who want to participate in the present study voluntarily.
Key exclusion criteria People
1) whose age are less than 20 years old,
2) whose systolic blood pressure is over 159 mmHg and diastolic blood pressure is over 99 mmHg,
3) who have previous medical histories interfering with IWT.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Nose, MD, PhD
Organization Shinshu University Graduate School of Medicine
Division name Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention
Zip code
Address 3-1-1 Asahi, Matsumoto, Japan
TEL 0263-37-2681
Email nosehir@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshi-ichiro Kamijo, MD, PhD
Organization Shinshu University Graduate School of Medicine
Division name Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention
Zip code
Address 3-1-1 Asahi, Matsumoto, Japan
TEL 0263-37-2682
Homepage URL
Email yoshikmj@shinshu-u.ac.jp

Sponsor
Institute Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention, Shinshu University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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
2014 Year 07 Month 08 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 Suspended
Date of protocol fixation
2011 Year 08 Month 02 Day
Date of IRB
Anticipated trial start date
2011 Year 08 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
2011 Year 08 Month 03 Day
Last modified on
2014 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007228

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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