UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000053568
Receipt number R000061126
Scientific Title The Effectiveness of Eight Weeks of Core Stability Exercises in Suspended and Stable Levels on the Selected muscle activation and Functional Disability of Amateur Soccer Players with Non-specific Chronic Low back pain
Date of disclosure of the study information 2024/09/04
Last modified on 2024/02/07 17:25:18

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Basic information

Public title

The Effectiveness of Eight Weeks of Core Stability Exercises in Suspended and Stable Levels on the Selected muscle activation and Functional Disability of Amateur Soccer Players with Non-specific Chronic Low back pain

Acronym

The Effectiveness of Eight Weeks of Core Stability Exercises in Suspended and Stable Levels on the Selected muscle activation and Functional Disability of Amateur Soccer Players with Non-specific Chronic Low back pain

Scientific Title

The Effectiveness of Eight Weeks of Core Stability Exercises in Suspended and Stable Levels on the Selected muscle activation and Functional Disability of Amateur Soccer Players with Non-specific Chronic Low back pain

Scientific Title:Acronym

The Effectiveness of Eight Weeks of Core Stability Exercises in Suspended and Stable Levels on the Selected muscle activation and Functional Disability of Amateur Soccer Players with Non-specific Chronic Low back pain

Region

Asia(except Japan)


Condition

Condition

experimental study

Classification by specialty

Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

examine the effect of unstable surface conditions (TRX) during core stability exercises on the pattern of trunk muscle activity and functional disability of athletes with non-specific chronic low back pain

Basic objectives2

Others

Basic objectives -Others

examine the effect of unstable surface conditions (TRX) during core stability exercises on the pattern of trunk muscle activity and functional disability of athletes with non-specific chronic low back pain

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Muscle electrical activity

Key secondary outcomes

Athlete disability scale


Base

Study type

Interventional


Study design

Basic design

n-of-1

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Core Stability Exercises in Suspended and Stable Levels

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

20 years-old <=

Age-upper limit

35 years-old >=

Gender

Male

Key inclusion criteria

age range of 20-35 years, reporting pain in the lower back between the pelvic crease and the chest (so that the pain in the VAS index is between 3-7) for at least the last 6 months
confirmation of low back pain by a specialist doctor
being an amateur (recreational soccer activity 2-3 sessions per week in the past year)

Key exclusion criteria

visible height abnormalities
vertebral slippage
disc herniation
regular use of painkillers
non-participation in the post-test at most one week after the end of the training program
absence in three consecutive sessions during training.

Target sample size

45


Research contact person

Name of lead principal investigator

1st name Esmaeil
Middle name
Last name Mozafaripour

Organization

Tehran University

Division name

Faculty of sport science

Zip code

1439813117

Address

North Karegar St, P.O.B:1439813117, Tehran, Iran

TEL

+989192787818

Email

E.mozafaripour@yahoo.com


Public contact

Name of contact person

1st name Esmaeil
Middle name
Last name Mozafaripour

Organization

Tehran University

Division name

Faculty of sport science

Zip code

1439813117

Address

North Karegar St, P.O.B:1439813117, Tehran, Iran

TEL

+989192787818

Homepage URL


Email

E.mozafaripour@yahoo.com


Sponsor or person

Institute

Tehran University

Institute

Department

Personal name



Funding Source

Organization

Tehran University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tehran University

Address

North Karegar St, P.O.B:1439813117, Tehran, Iran

Tel

+989192787818

Email

E.mozafaripour@yahoo.com


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 09 Month 04 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

45

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results

2024 Year 03 Month 01 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2023 Year 03 Month 01 Day

Date of IRB

2023 Year 08 Month 01 Day

Anticipated trial start date

2023 Year 06 Month 01 Day

Last follow-up date

2023 Year 08 Month 10 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 02 Month 07 Day

Last modified on

2024 Year 02 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061126