UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000056199
Receipt number R000063636
Scientific Title Development of an exercise program for low back pain in baseball players
Date of disclosure of the study information 2024/11/22
Last modified on 2025/05/21 14:16:11

* 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

Development of an exercise program for low back pain in baseball players

Acronym

Development of an exercise program for low back pain in baseball players

Scientific Title

Development of an exercise program for low back pain in baseball players

Scientific Title:Acronym

Development of an exercise program for low back pain in baseball players

Region

Japan


Condition

Condition

Low Back Pain

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To test the effectiveness of core exercises or aerobic exercises on college baseball players with low back pain.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pain intensity evaluation
Tampa scale for kinesiophobia
Muscle hardness of the multifidus by ultrasound elastography

Key secondary outcomes

Body composition
Posture Alignment
Trunk muscle strength
Flexibility test
Balance test
Endurance test
Questionnaire related to baseball


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Aerobic exersice

Interventions/Control_2

Core stability exersice

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

30 years-old >=

Gender

Male

Key inclusion criteria

Players enroll in Josai International University Baseball Team.
Those who have low back pain but can participate in baseball practice

Key exclusion criteria

Someone who is prohibited from exercising
A neurological disorder that affects measurements

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Hidetoshi
Middle name
Last name Nakao

Organization

Josai International University

Division name

Faculty of Social Work Studies. Department of Physical Therapy.

Zip code

283-8555

Address

1Gumyo, Togane City, Chiba Pref.

TEL

0475-55-8800

Email

h_nakao@jiu.ac.jp


Public contact

Name of contact person

1st name Hidetoshi
Middle name
Last name Nakao

Organization

Josai International University

Division name

Faculty of Social Work Studies. Department of Physical Therapy.

Zip code

283-8555

Address

1Gumyo, Togane City, Chiba Pref.

TEL

0475-55-8800

Homepage URL


Email

h_nakao@jiu.ac.jp


Sponsor or person

Institute

Josai International University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

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

Josai International University

Address

1Gumyo, Togane City, Chiba Pref.

Tel

0475-55-7832

Email

research-c@jiu.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

2024 Year 11 Month 22 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

26

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

No longer recruiting

Date of protocol fixation

2024 Year 10 Month 20 Day

Date of IRB

2024 Year 08 Month 07 Day

Anticipated trial start date

2024 Year 11 Month 28 Day

Last follow-up date

2026 Year 11 Month 28 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 11 Month 19 Day

Last modified on

2025 Year 05 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063636