UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055927 |
|---|---|
| Receipt number | R000063896 |
| Scientific Title | Development of exercise interventions for the prevention of lumbar spondylolysis |
| Date of disclosure of the study information | 2024/10/24 |
| Last modified on | 2025/04/25 09:18:09 |
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Basic information
Public title
Development of exercise interventions for the prevention of lumbar spondylolysis
Acronym
Development of exercise interventions for the prevention of lumbar spondylolysis.
Scientific Title
Development of exercise interventions for the prevention of lumbar spondylolysis
Scientific Title:Acronym
Development of exercise interventions for the prevention of lumbar spondylolysis
Region
| Japan |
Condition
Condition
lumbar spondylolysis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to identify effective exercises for the prevention of lumbar spondylolysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Quantitative evaluation of pelvic and spinal alignment using CT-like MRI
Key secondary outcomes
Body composition evaluation using DXA
Evaluation of muscle flexibility and joint range of motion
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervene in the exercise program to warm up before sports activities. The frequency of intervention will be 5 times a week. Intervention time per session is 10-15 minutes.
Interventions/Control_2
No specific exercise program is specified and treated as a non-intervention group.
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
| 12 | years-old | <= |
Age-upper limit
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Junior high school students with the consent of their parents or guardians will be included in the study. Participants in this experiment must have no previous history of cardiac or circulatory disease.
Key exclusion criteria
Patients will be excluded if, at the time of participation in this study, they have a serious illness or injury that interferes with their daily life. In addition, we will exclude patients with claustrophobia because MRI imaging will be performed. The presence or absence of metal objects (pacemakers, artificial joints, colored contacts, etc.) in the body will be checked beforehand, and patients will be excluded if applicable. The presence or absence of metal objects in the body (pacemakers, artificial joints, colored contacts, etc.) will be confirmed prior to the start of the experiment, and patients will be excluded if applicable.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshiharu |
| Middle name | |
| Last name | Tsutsui |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
3591192
Address
2-579-15, Mikajima, Tokorozawa, Saitama
TEL
0429476848
t-tsutsui@aoni.waseda.jp
Public contact
Name of contact person
| 1st name | Toshiharu |
| Middle name | |
| Last name | Tsutsui |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
3591192
Address
2-579-15, Mikajima, Tokorozawa, Saitama
TEL
0429476848
Homepage URL
t-tsutsui@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
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
Ethics Review Procedures concerning Research with Human Subjects in Waseda University
Address
1-104, Totsukacho, Shinjuku, Tokyo
Tel
0352721639
rinri@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
| 2024 | Year | 10 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063896
