UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033303 |
|---|---|
| Receipt number | R000037966 |
| Scientific Title | 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 | 2025/01/15 11:25:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Influence of standing back extension exercise on lumbar hemodynamic changes for prevention and improvement of low back pain.
Acronym
Muscle physiological change of the lumbar region due to exercise for prevention and improvement of low back pain.
Scientific Title
Influence of standing back extension exercise on lumbar hemodynamic changes for prevention and improvement of low back pain.
Scientific Title:Acronym
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
| 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
Partially published
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
Suspended
Date of protocol fixation
| 2017 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | 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 | 07 | Month | 06 | Day |
Last modified on
| 2025 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037966
