Protocol summary

Study aim
A comparative study of the effects of two combined Pilates protocols on pain, balance, range of motion, and proprioception in young people aged 20 to 30 years with chronic non-specific low back pain
Design
Dividing 30 people into 3 groups of 10 people, semi-experimental, applied and comparative study
Settings and conduct
Intervention in Hamedan city, using VAS questionnaire to assess pain, Stork test for static balance, Y test for dynamic balance, meter to assess lumbar range of motion and goniometer to measure lumbar proprioception
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) No respiratory problems 2) Age between 20 and 30 years 3) Normal body mass index (19 to 25) 4) No pathological problems, spinal stenosis, and disc herniation 5) Pain due to muscle weakness 6) History of back pain for more than three months 7) No abnormalities in the spine and lower limbs 8) No history of surgery in the spine and lower limbs 9) Self-reported pain 4 to 6 VAS index Inclusion criteria: 1) Feeling pain and disability during the training period 2) Absence in more than 2 sessions of the entire training program 3) Unwillingness of the subject to continue the research 4) Not participating in training sessions regularly
Intervention groups
Pilates exercises with walking group Pilates exercises with stretching exercises group Control group
Main outcome variables
Pain, static and dynamic balance, lumbar range of motion, lumbar proprioception

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250920067295N1
Registration date: 2026-02-14, 1404/11/25
Registration timing: prospective

Last update: 2026-02-14, 1404/11/25
Update count: 0
Registration date
2026-02-14, 1404/11/25
Registrant information
Name
Fateme Azimi behmand
Name of organization / entity
The university of Shahid beheshti
Country
Iran (Islamic Republic of)
Phone
+98 81 3251 5205
Email address
fatemeazimibehmand5193@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-02-18, 1404/11/29
Expected recruitment end date
2026-03-19, 1404/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two combined Pilates protocols on the level of pain, balance, range of motion and proprioception in young people with non-specific chronic low back pain
Public title
combined Pilates exercises
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
No respiratory problems Age between 20 and 30 years Normal body mass index (19 to 25) No pathological problems, spinal stenosis, or herniated discs Pain due to muscle weakness History of back pain for more than three months No abnormalities in the spine and lower extremities No history of surgery in the spine and lower extremities Self-reported pain 4 to 6 VAS index
Exclusion criteria:
Feeling pain and disability during the training period Absence from more than 2 sessions of the entire training program Unwillingness of the subject to continue the research Not participating in training sessions regularly
Age
From 20 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Selecting 30 people by simple randomization using dice numbered from 1 to 30 for one of three groups of 10 people.
Blinding (investigator's opinion)
Single blinded
Blinding description
Informing participants about the general process of conducting the study and not being aware of things that could distort the test results.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University
Street address
No. 33, Roshan Alley, Takhti Street
City
Hamedan
Province
Hamadan
Postal code
6514697358
Approval date
2024-10-14, 1403/07/23
Ethics committee reference number
IR.SBU.REC.1403.099

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
Plyometric Combination Protocol
Timepoint
Before the intervention, 8 weeks after the intervention
Method of measurement
VAS index questionnaire for pain assessment, stork test for static balance, Y test for dynamic balance, tape measure for lumbar range of motion, goniometer for pelvic proprioception

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: pilates with walking
Category
Rehabilitation

2

Description
Intervention group: Pilates with stretching exercises
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid gym
Full name of responsible person
Fateme azimi behmand
Street address
No. 33, Roshan Alley, Takhti Street
City
Hamedan
Province
Hamadan
Postal code
6514697358
Phone
+98 901 623 5193
Email
fatemeazimibehmand5193@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
the university of shahid beheshti
Full name of responsible person
Deputy Director of Research and Technology
Street address
No. 33, Roshan Alley, Takhti Street
City
Hamedan
Province
Hamadan
Postal code
6514697358
Phone
+98 901 623 5193
Email
fatemeazimibehmand5193@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
the university of shahid beheshti
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
The university of Shahid beheshti
Full name of responsible person
Fateme azimi behmand
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No. 33, Roshan Alley, Takhti Street
City
Hamedan
Province
Hamadan
Postal code
6414697358
Phone
+98 81 3251 5205
Email
fatemeazimibehmand5193@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The university of Shahid beheshti
Full name of responsible person
Fariborz hovanloo
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Tehran, Student Boulevard, Shahid Beheshti University
City
Tehran
Province
Tehran
Postal code
6514697358
Phone
+98 912 793 4486
Email
fhovanloo@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Fateme azimi behmand
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No. 33, Roshan Alley, Takhti Street
City
Hamedan
Province
Hamadan
Postal code
6514697358
Phone
+98 81 3251 5205
Email
fatemeazimibehmand5193@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because the data is not in a form that can be used by others.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the information that includes the result is published
When the data will become available and for how long
Access period starts 6 months after results are published
To whom data/document is available
Nobody
Under which criteria data/document could be used
Not applicable and not accessible
From where data/document is obtainable
Not accessible.
What processes are involved for a request to access data/document
Not accessible.
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