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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039448
Receipt No. R000044979
Scientific Title Effects of trunk flexibility exercise on back pain prevention in college rugby players
Date of disclosure of the study information 2020/02/10
Last modified on 2020/02/10

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Basic information
Public title Effects of trunk flexibility exercise on back pain prevention in college rugby players
Acronym Effects of trunk flexibility exercise on back pain prevention in college rugby players
Scientific Title Effects of trunk flexibility exercise on back pain prevention in college rugby players
Scientific Title:Acronym Effects of trunk flexibility exercise on back pain prevention in college 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 flexibility exercise on rugby players. To investigate the relationship between physical factors and back pain in college student 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 Jacobi line and bend the trunk forward while pulling it vertically. At that 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 organized gymnastics and cool down. The number of this exercise is 10 times x 3 sets. There will be 1 minute between interventions for a total of 5 minutes of flexibility 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
18 years-old <=
Age-upper limit
24 years-old >=
Gender Male
Key inclusion criteria Participate in the official Kanto College Rugby League match in 2019 and be a member of the Saitama Prefecture Association.
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 is difficult
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
Email 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
Email y.kikuike1009@gmail.com

Sponsor
Institute Saitama Medical University Graduate School of Medicine
Institute
Department

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
Email 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

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 10 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
2020 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 03 Month 01 Day
Last follow-up date
2021 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 02 Month 10 Day
Last modified on
2020 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044979

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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