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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033303
Receipt No. R000037966
Official scientific title of the study Influence of standing back extension exercise on lumbar hemodynamic changes for prevention and improvement of low back pain.
Date of disclosure of the study information 2018/07/06
Last modified on 2018/07/06

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Basic information
Official scientific title of the study Influence of standing back extension exercise on lumbar hemodynamic changes for prevention and improvement of low back pain.
Title of the study (Brief title) Muscle physiological change of the lumbar region due to exercise for prevention and improvement of low back pain.
Region
Japan

Condition
Condition Healthy individuals and nursing care workers.
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate muscle physiological changes due to repeated standing back extension exercises for healthy volunteers and nursing care staff, to obtain a finding for back pain prevention.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Muscle physiological change by standing back extension exercise
Key secondary outcomes Change in muscle activity, circulatory dynamics and elastic modulus by exercise intervention.
Questionnaire on lumbar fatigue degree, low back pain.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Standing back extension exercise.
Interventions/Control_2
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 Healthy individuals and nursing care workers who have no back pain enough to treat in the past 3 months.
Key exclusion criteria Those who received treatment with low back pain in the past 3 months.
Target sample size 50

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

Public contact
Name of contact person Tsuneo Kumamoto
Organization Hokkaido Chitose College of Rehabilitation
Division name Department of Rehabilitation
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)

Secondary IDs
Secondary IDs YES
Study ID_1 18001
Org. issuing International ID_1 Hokkaido chitose college of rehabilitation ethics committee
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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 06 Month 12 Day
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 06 Day
Last modified on
2018 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037966

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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