UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000033302 |
|---|---|
| Receipt number | 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 | 2021/07/09 10:46:40 |
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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
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
t-kumamoto@chitose-reha.ac.jp
Sponsor or person
Institute
Hokkaido Chitose College of Rehabilitation
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
33
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
| 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
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 08 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 08 | Day |
Date analysis concluded
| 2021 | Year | 07 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 06 | Day |
Last modified on
| 2021 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037964
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
