The aim of this study was to investigate the effect of eight weeks of Pilates exercise on the mat and in the water in female patients with chronic non-specific low back pain.
Design
Double-blind randomized clinical trial
Settings and conduct
The exercises were conducted in the pool and a gym at Bu Ali-Sina University.
Participants/Inclusion and exclusion criteria
Age between 20-30 years
Existence of chronic non-specific low back pain at least 3 month
No history of surgery or fracture in spine and lower limb
Intervention groups
Pilates exercise in the water
Pilates exercise on the mat
Effect of eight-week water and land Pilates on pain, disability and balance in female college student with chronic non-specific low back pain
Public title
Effect of eight-week water and land Pilates on female patients with chronic non-specific low back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of chronic non-specific low back pain for at least three months
Exclusion criteria:
Structural dysfunction in the spine
A history of surgery or fracture in spine and lower limb
any other illness that can affect the research variables
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
24
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects randomized divided in two steps. At first each subject selected a number between the interval of 1 to 24 using the draw, then 12 random numbers were selected using Random number generator software from 24 to 1 numbers and then according to the numbers produced and the numbers selected, the subjects were divided into two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in study and researcher that do laboratory tests were not aware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Science, in front of People's Garden, Shahid Fahmideh Street
City
Hamedan
Province
Hamadan
Postal code
6517838678
Approval date
2019-01-05, 1397/10/15
Ethics committee reference number
IR.UMSHA.REC.1397.762
Health conditions studied
1
Description of health condition studied
chronic non-specific low back pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain severity
Timepoint
Before intervention (pre-test) and 8 weeks after intervention (post-test)
Method of measurement
The Visual Analogue Scale
2
Description
Functional disability
Timepoint
Before intervention (pre-test) and 8 weeks after intervention (post-test)
Method of measurement
The Oswestry Disability Questionnaire
3
Description
Balance
Timepoint
Before intervention (pre-test) and 8 weeks after intervention (post-test)
Method of measurement
Biodex Balance System
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: perform the Pilates exercises in the water for eight weeks (three session per week)
Category
Rehabilitation
2
Description
Second intervention group: perform the Pilates exercises on the mat for eight weeks (three session per week)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-ali Sina university
Full name of responsible person
Ali Yalfani
Street address
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street
City
Hamedan
Province
Hamadan
Postal code
6517833131
Phone
+98 81 3838 1422
Email
Ali_yalfani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bu Ali-Sina University
Full name of responsible person
Gholamhossein Majzoubi
Street address
Vice Chancellery For Research Affairs, Bu Ali Sina University, Chahar Bagh Martyr Mustafa Ahmadi Roshan
City
Hamedan
Province
Hamadan
Postal code
6517833131
Phone
+98 81 3838 1601
Email
sakhai@basu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bu Ali-Sina University
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bu Ali-Sina University
Full name of responsible person
Ali Yalfani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Bu Ali Sina University, Chahar Bagh of martyr Mustafa Ahmadi Roshan
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1422
Email
ali_yalfani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu Ali-Sina University
Full name of responsible person
Ali Yalfani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Bu Ali Sina University, Chahar Bagh of martyr Mustafa Ahmadi Roshan
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1422
Email
ali_yalfani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak University, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcomes of the study will be shared.
When the data will become available and for how long
Access period starting from 1398
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Using information to help treat patients
From where data/document is obtainable
Ali Yalfani
Email: Ali_yalfani@yahoo.com
Tel: 00988138381422
What processes are involved for a request to access data/document
After receiving the e-mail if any possibility files to be shared.