Protocol summary

Study aim
The effect of six weeks of Pilates training on non-specific chronic low back pain
Design
Thirty patients with non-specific chronic low back pain(30 to 35 year) were randomly selected and randomly divided into experimental and control groups(n:15) the experimental group received pilates exercises for 6 weeks and the control group received physiotherapy modalities. The pain questionnaire, hand dynamometer, digital goniometer were used to assessthe variables. independent and dependent t were used to analyze the data.
Settings and conduct
The clinical study of sport clubs and blind blindness on the control group of 15 people who received physical therapy modalities from clinics in Tehran.
Participants/Inclusion and exclusion criteria
Not having any fractures in the lower extremities and spine, not having a history of knee surgery, having no history of inflammatory diseases, lacking physical activity limiting diseases, lacking systemic or pulmonary systemic lung disease, or having a history of back pain for more than 3 months
Intervention groups
The experimental group performed 15 Pilates exercises for 6 weeks. The 15-person experimental group received physiotherapy modalities for 6 weeks
Main outcome variables
Independent variable: Pilates exercises for 6 weeks Dependent variable: pain, lower extremity limb movement, muscle strength, 4 female and female hamstrings

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181011041309N1
Registration date: 2019-12-22, 1398/10/01
Registration timing: prospective

Last update: 2019-12-22, 1398/10/01
Update count: 0
Registration date
2019-12-22, 1398/10/01
Registrant information
Name
Mahsa Jalilian
Name of organization / entity
University raja gazvin
Country
Iran (Islamic Republic of)
Phone
+98 21 3386 7246
Email address
mahsa.jaliliyan1371@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-23, 1398/10/02
Expected recruitment end date
2020-08-02, 1399/05/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of six weeks Pilates training on range of motion of lower extremity and muscle strength of quadriceps and hamstring in the women with nonspecific chronic LBP
Public title
The effect of six weeks Pilates training on range of motion of lower extremity and muscle strength of quadriceps and hamstring in the women with nonspecific chronic LBP
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Not having any abdominal fractures in the lower extremities and the spine Not having a history of knee surgery Has no history of inflammatory diseases Not having illnesses limiting physical activity Not having systemic diseases of the kidneys, lungs, gastrointestinal tract or blood History of back pain for more than 3 months
Exclusion criteria:
having any abdominal fractures in the lower extremities and the spine having a history of knee surgery history of inflammatory diseases having illnesses limiting physical activity having systemic diseases of the kidneys, lungs, gastrointestinal tract or blood not History of back pain for more than 3 months
Age
From 30 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The control group was kept blind and received physiotherapy modalities from physiotherapy clinics.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Committee on Ethics in Biomedical Research
Street address
Motehari street
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-10-12, 1398/07/20
Ethics committee reference number
IR.SSRC.REC.1398.078

Health conditions studied

1

Description of health condition studied
Non-specific chronic low back pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Non-specific chronic low back pain
Timepoint
Six weeks
Method of measurement
Physician Examination Sheet

Secondary outcomes

1

Description
The Pain
Timepoint
Six weeks
Method of measurement
Pain Questionnaire

2

Description
Motion Range
Timepoint
Six weeks
Method of measurement
Gonia Meter

3

Description
Muscle Strength
Timepoint
Six weeks
Method of measurement
Dynamometer

Intervention groups

1

Description
Intervention group: Experimental group receiving Pilates exercises
Category
Diagnosis

2

Description
Control group: Practices receive physiotherapy modalities
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Ladies Campus Garden
Full name of responsible person
Mahsa Jaliliyan
Street address
Across The Street From Azadegan Water Park
City
Tehran
Province
Tehran
Postal code
17185/1158
Phone
+98 21 3386 7246
Email
mahsa.jaliliyan1371@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Raja University Of Qazvin
Full name of responsible person
Dr. Bahaghighat
Street address
Raja University of Motahari Boulevard of Norouzian Street Intersection Qazvin
City
Gazvin
Province
Qazvin
Postal code
34148-95834
Phone
+98 28 3367 7101
Email
mahsa.jaliliyan1371@gmail.com
Grant name
10000000
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
University Of Raja - Qazvin
Full name of responsible person
Mahsa Jaliliyan
Position
University Student
Latest degree
Master
Other areas of specialty/work
University Student
Street address
Shahid Rajaie 2 Dana Street, Razavi Ave.
City
Tehran
Province
Tehran
Postal code
1855976673
Phone
+98 21 3386 7246
Email
mahsa.jaliliyan1371@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Hosein Barati
Position
Associate Professor of Sports Medicine
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Heritage Square Shams Abad Bridge Hemmat Corner Alley No.8 Floor3 Unit 5
City
Tehran
Province
Tehran
Postal code
1667753316
Phone
+98 21 2631 3380
Email
ahbarati20@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of Raja Ghazvin
Full name of responsible person
Mahsa Jalilian
Position
Student
Latest degree
Master
Other areas of specialty/work
Student
Street address
No101 , Shahid Rajaei Avenue , Baradarane Maroof Street , Razaviyeh Township , Afsariyeh
City
Tehran
Province
Tehran
Postal code
1855976673
Phone
+98 21 3386 7246
Fax
Email
mahsa.jaliliyan1371@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Anyone's personal information is kept with us only when the results are published in general to both groups
When the data will become available and for how long
1399
To whom data/document is available
mahsa jaliliyan amir hosein barati
Under which criteria data/document could be used
Just evaluate the variables and draw conclusions
From where data/document is obtainable
mahsa jailiyan 09229332856
What processes are involved for a request to access data/document
Variables are evaluated first, then 6 weeks Pilates exercises are performed, and after six weeks the variables are re-evaluated and the results are communicated.
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