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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027162
Receipt No. R000030851
Scientific Title Examination of the exercise instruction by the medical examination for the stress reduction
Date of disclosure of the study information 2017/06/02
Last modified on 2017/04/26

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Basic information
Public title Examination of the exercise instruction by the medical examination for the stress reduction
Acronym Examination of the exercise instruction by the medical examination for the stress reduction
Scientific Title Examination of the exercise instruction by the medical examination for the stress reduction
Scientific Title:Acronym Examination of the exercise instruction by the medical examination for the stress reduction
Region
Japan

Condition
Condition Obese patients
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we examine it whether the 6-month exercise instruction to patients with metabolic chic syndrome improves stress and insomnia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes GHQ(general health questionnaire)-12
Key secondary outcomes Pittsburgh Sleep Quality Index

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 6-month exercise instruction
Interventions/Control_2 Non-exercise instruction
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
40 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria The subject corresponds to the metabolic syndrome diagnostic criteria or the spare group in selected medical examination testee.
Key exclusion criteria They receive medication medical treatment for diabetes, hypertension, dyslipidemia, mental disorder, insomnia.
Pregnancy or the pregnancy is possible.
They are complicated with a malignant tumor.
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Sohachi Fujimoto
Organization kawasaki medical school
Division name health care medicine
Zip code
Address 577, Matsushima, Kurashiki, Okayama
TEL 086-462-1111
Email fujiso@med.kawasaki-m.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Sohachi Fujimoto
Organization kawasaki medical school
Division name health care medicine
Zip code
Address 577, Matsushima, Kurashiki, Okayama
TEL 086-462-1111
Homepage URL
Email fujiso@med.kawasaki-m.ac.jp

Sponsor
Institute kawasaki medical school department of health care medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization japan

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
2017 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
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 Preinitiation
Date of protocol fixation
2017 Year 04 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 02 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
2017 Year 04 Month 27 Day
Last modified on
2017 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030851

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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