UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039364 |
|---|---|
| Receipt number | R000044889 |
| Scientific Title | Preventive effects of low back pain by trunk flexibility exercise in high school rugby players |
| Date of disclosure of the study information | 2020/02/02 |
| Last modified on | 2023/02/14 18:39:39 |
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Basic information
Public title
Preventive effects of low back pain by trunk flexibility exercise in high school rugby players
Acronym
Preventive effects of low back pain by trunk flexibility exercise in high school rugby players
Scientific Title
Preventive effects of low back pain by trunk flexibility exercise in high school rugby players
Scientific Title:Acronym
Preventive effects of low back pain by trunk flexibility exercise in high school rugby players
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of back pain prevention training by trunk exercises on rugby players.To investigate the relationship between physical factors and back pain in high school rugby players.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Low back pain incidence
Six months after the start of the intervention
Key secondary outcomes
ROM flex ext rotation lateral flex
Back range of motion
FFD
SLR
Thomas test
Core Stability test
Standing long jump
30m dash
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Trunk flexibility gymnastics.
Intervention: Trunk exercise is performed by applying a strap on the waist. A strap is attached to the Jacoby line and bend the trunk forward while pulling it vertically. At this time, the knee joint is bent while performing. The intervention period is six months, and it is performed for each club activity as part of club activities such as preparing exercise and cool down. The number of this exercise is 10 times x 3 sets. There will be 1 minute between interventions and a total of 5 minutes of this flexible exercise.
Interventions/Control_2
control
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
| 16 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male
Key inclusion criteria
2019 national high school rugby football tournament Saitama prefecture qualifying best 16 or more teams
Key exclusion criteria
Those who cannot obtain written consent for participation in this study
Those who cannot start at the start of measurement
Patients who have undergone orthopedic surgery within one month due to trunk (including lumbar) symptoms
Those who have difficulty continuing self-exercise
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kiyokazu |
| Middle name | |
| Last name | Akasaka |
Organization
Saitama Medical University
Division name
School of Physical Therapy
Zip code
350-0496
Address
981 Kawakado. Moroyama.Iruma.Saitama
TEL
049-295-1001
akasaka-smc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Kikuchi |
Organization
Saitama Medical University Graduate School of Medicine
Division name
Master and Doctoral Program in Physical Therapy
Zip code
350-0496
Address
981 Kawakado. Moroyama.Iruma.Saitama
TEL
049-295-1001
Homepage URL
y.kikuike1009@gmail.com
Sponsor or person
Institute
Saitama Medical University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Graduate School of Medicine
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
Saitama Medical University Ethics Review Committee
Address
38.Morohongou.Moroyama.Iruma.Saitama
Tel
049-276-2143
ethics@saitama-med.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
埼玉医科大学大学院(埼玉県)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 14 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 02 | Day |
Last modified on
| 2023 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044889
