UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027162 |
|---|---|
| Receipt number | 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 | 2020/06/03 12:59:12 |
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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
Name of lead principal investigator
| 1st name | Sohachi |
| Middle name | |
| Last name | Fujimoto |
Organization
kawasaki medical school
Division name
health care medicine
Zip code
701-0192
Address
577, Matsushima, Kurashiki, Okayama
TEL
086-462-1111
fujiso@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Sohachi |
| Middle name | |
| Last name | Fujimoto |
Organization
kawasaki medical school
Division name
health care medicine
Zip code
701-0192
Address
577, Matsushima, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
fujiso@med.kawasaki-m.ac.jp
Sponsor or person
Institute
kawasaki medical school department of health care medicine
Institute
Department
Personal name
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
Research ethics committee of kawasaki medical school and hospital
Address
577, Matsushima, Kurashiki, Okayama
Tel
086-462-1111
kmsrec@med.kawasaki-m.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
| 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
22
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
| 2017 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030851
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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