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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034079
Receipt No. R000038851
Scientific Title The assessment of the stress reduction effect using shoulder muscle hardness meter
Date of disclosure of the study information 2018/11/01
Last modified on 2019/03/12

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Basic information
Public title The assessment of the stress reduction effect using shoulder muscle hardness meter
Acronym The assessment of the stress reduction effect using shoulder muscle hardness meter
Scientific Title The assessment of the stress reduction effect using shoulder muscle hardness meter
Scientific Title:Acronym The assessment of the stress reduction effect using shoulder muscle hardness meter
Region
Japan

Condition
Condition Healthy men and women
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the effectiveness of evaluating the stress reduction effect using shoulder muscle hardness meter
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Heart rate
HF component
LF/HF component
Pulse wave
Hardness of shoulder muscle
Thermography
Healing scale
Japanese perceived stress score
Stiffness questionnaire
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Maneuver Other
Interventions/Control_1 Exercise
for one hour
Interventions/Control_2 Massage
for one hour
Interventions/Control_3 Okada Purifying Therapy
for one hour
Interventions/Control_4 rest on a bed
for one hour
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
74 years-old >=
Gender Male and Female
Key inclusion criteria Healthy men and women
Key exclusion criteria Persons with disease
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Seiya
Middle name
Last name Uchida
Organization MOA Health Science Foundation
Division name Research Department
Zip code 413-0038
Address 1-1-60 Nishiatami, Atami-shi, Shizuoka
TEL +81-557-86-0663
Email seiya-u@mhs.or.jp

Public contact
Name of contact person
1st name Seiya
Middle name
Last name Uchida
Organization MOA Health Science Foundation
Division name Research Department
Zip code 413-0038
Address 1-1-60 Nishiatami, Atami-shi, Shizuoka
TEL +81-557-86-0663
Homepage URL
Email seiya-u@mhs.or.jp

Sponsor
Institute MOA Health Science Foundation
Institute
Department

Funding Source
Organization MOA Health Science Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization MOA Health Science Foundation
Address 1-1-60, Nishiatamicho, Atami, Sizuoka
Tel 0557-86-0663
Email seiya-u@mhs.or.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
2018 Year 11 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 01 Day
Date of IRB
2018 Year 04 Month 13 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2021 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 10 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038851

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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