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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033302
Receipt No. R000037964
Scientific Title Verification of the change of multifidus muscle shear modulus by standing back extension exercise on the muscle fatigue model of the lower back muscle
Date of disclosure of the study information 2018/07/06
Last modified on 2020/07/07

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Basic information
Public title Verification of the change of multifidus muscle shear modulus by standing back extension exercise on the muscle fatigue model of the lower back muscle
Acronym Influence of standing back extension exercise on lumbar hemodynamics change.
Scientific Title Verification of the change of multifidus muscle shear modulus by standing back extension exercise on the muscle fatigue model of the lower back muscle
Scientific Title:Acronym Influence of standing back extension exercise on lumbar hemodynamics change.
Region
Japan

Condition
Condition Healthy individuals
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the muscle physiological change by repeated standing back extension exercise for healthy volunteers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Muscle physiological change by five sets of standing back extension exercise
Key secondary outcomes Change in muscle activity, circulatory dynamics and elastic modulus by exercise intervention.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
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 Prevention
Type of intervention
Maneuver
Interventions/Control_1 After performing Sorensen fatigue test for 60 seconds, 5 sets of standing back extension exercise.
Interventions/Control_2 After performing Sorensen fatigue test for 60 seconds,keeping at rest standing.
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
18 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Those subjects have no back pain in the past 3 months.
Key exclusion criteria Subjects excluded those with a history of Musculoskeletal disorders or central nervous system disease.
Target sample size 44

Research contact person
Name of lead principal investigator
1st name Tsuneo
Middle name
Last name Kumamoto
Organization Hokkaido Chitose College of Rehabilitation
Division name Department of Rehabilitation
Zip code 0660055
Address Satomi 2-10, Chitose, Hokkaido
TEL 0123-28-5331
Email t-kumamoto@chitose-reha.ac.jp

Public contact
Name of contact person
1st name Tsuneo
Middle name
Last name Kumamoto
Organization Hokkaido Chitose College of Rehabilitation
Division name Department of Rehabilitation
Zip code 0660055
Address Satomi 2-10, Chitose, Hokkaido
TEL 0123-28-5331
Homepage URL
Email t-kumamoto@chitose-reha.ac.jp

Sponsor
Institute Hokkaido Chitose College of Rehabilitation
Institute
Department

Funding Source
Organization JSPS KAKENHI
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Research Ethics Committee Hokkaido Chitose College of Rehabilitation
Address Satomi 2-10, Chitose, Hokkaido
Tel 0123-28-5331
Email rinrishinsa@chitose-reha.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
2018 Year 07 Month 06 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 07 Month 06 Day
Date of IRB
2018 Year 09 Month 04 Day
Anticipated trial start date
2018 Year 08 Month 20 Day
Last follow-up date
2020 Year 09 Month 04 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 07 Month 06 Day
Last modified on
2020 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037964

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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