UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050742 |
|---|---|
| Receipt number | R000057817 |
| Scientific Title | Research on effective exercise therapy for musculoskeletal dysfunction |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/04/01 00:31:21 |
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Basic information
Public title
Research on effective exercise therapy for musculoskeletal dysfunction
Acronym
Research on effective exercise therapy for musculoskeletal dysfunction
Scientific Title
Research on effective exercise therapy for musculoskeletal dysfunction
Scientific Title:Acronym
Research on effective exercise therapy for musculoskeletal dysfunction
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To provide primary prevention of locomotory injuries in the general public and athletes who possess a risk of low back pain and to test the effectiveness of the program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SF-36 (before intervention, 3 and 6 months after intervention)
Key secondary outcomes
Presenteeism and Labor Productivity (University of Tokyo one-item version), Pain (NRS), Locomotor Assessment (Locomo 25),
Koji Awareness, Motor Control Evaluation, Straight Leg Raise (SLR), Finger Floor Distance (FFD) , Heel Buttock Distance (HBD)
All will be measured before the intervention, 3 months after the intervention, and 6 months after the intervention.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Teaching motor control exercises based on yoga, Pilates, and functional training that may be effective in preventing back pain. 45 minutes of group exercises once a week for 3 months.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who have publicized and applied for the implementation of an exercise intervention program for the prevention of low back pain.
Key exclusion criteria
Those who have an outpatient disease and cannot obtain consent from their attending physician to participate in this study.
Women of childbearing potential.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kaneoka |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
202-0021
Address
3-4-1, Higashifushimi, Nishitokyo, Tokyo
TEL
042-452-7156
kaneoka@waseda.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Morito |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
202-0021
Address
3-4-1, Higashifushimi, Nishitokyo, Tokyo
TEL
042-452-7156
Homepage URL
mori_tsuyo88@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Japan Sports Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Management Division, Research Promotion Department, Waseda University
Address
1-104 Totsukacho, Shinjuku-ku, Tokyo
Tel
03-5272-4652
rps-management@list.waseda.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
| 2023 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 04 | Month | 01 | Day |
Last modified on
| 2023 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057817
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
