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
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
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
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
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
