Protocol summary

Study aim
To determine the effects of comprehensive and local corrective exercises on knee valgus and gluteal muscle strength and endurance in women with gluteal muscle dysfunction
Design
A randomized controlled trial with three parallel groups (local corrective exercise, comprehensive corrective exercise, and control), double-blind in outcome assessment, simple randomization with 45 women; random sequence generated using the Random function in Excel and group allocation after screening for inclusion criteria.
Settings and conduct
The study will be conducted on women with gluteal muscle dysfunction at “Zarban” gym in Gorgan. Participants will be assigned to three parallel groups (local corrective exercise, comprehensive corrective exercise, and control). Exercises will be performed for 12 weeks under the researcher’s supervision. Assessors and the data analyst will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: gluteal muscle dysfunction; age 18–50; female; physically inactive and no regular exercise in the past 6 months; no medical contraindication for exercise Exclusion criteria: history of injury or surgery in the lumbopelvic or lower limb region; progressive neuromuscular disease; severe joint disorder; disc herniation or spondylolisthesis; use of assistive walking devices
Intervention groups
Local corrective exercise group: 12-week program focused on gluteal muscles; Comprehensive corrective exercise group: 12-week program targeting lower limbs and gluteal muscles; Control group: continue usual daily activities without specific exercise program.
Main outcome variables
Gluteal muscle strength (abduction, external rotation, hip extension); gluteal muscle endurance (single-leg bridge hold time); static and dynamic knee valgus (Q-angle and femur–tibia angle during standing and single-leg squat)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180521039762N5
Registration date: 2026-02-05, 1404/11/16
Registration timing: prospective

Last update: 2026-02-05, 1404/11/16
Update count: 0
Registration date
2026-02-05, 1404/11/16
Registrant information
Name
Afshin Moghadasi
Name of organization / entity
University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3793 4208
Email address
afshin.moghadasi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-02-06, 1404/11/17
Expected recruitment end date
2026-02-18, 1404/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Comprehensive and Localized Corrective Exercises on Knee Valgus and Gluteal Muscle Strength and Endurance in Women with Gluteal Muscle Dysfunction
Public title
Effect of Corrective Exercises on Knee Valgus and Gluteal Muscle Function in Women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of gluteal muscle dysfunction Age range between 18 and 50 years Female gender Physical inactivity and no regular exercise participation during the past 6 months No medical contraindication for participation in exercise programs
Exclusion criteria:
History of serious injury or surgery in the lumbopelvic region or lower limbs Presence of progressive neuromuscular diseases Presence of severe joint disorders such as hip or knee osteoarthritis Intervertebral disc herniation or spondylolisthesis Use of assistive walking devices such as a cane
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
After the initial assessment and screening for inclusion and exclusion criteria, eligible participants will enter the randomization phase. Randomization in this study will be performed as simple randomization with an individual randomization unit. The random sequence will be generated using the Random function in Microsoft Excel. Based on this sequence, participants will be randomly assigned to three equal groups: the local corrective exercise group, the comprehensive corrective exercise group, and the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be aware of their group assignment because the study objectives and interventions are explained to them, and blinding participants is not ethically possible. However, individuals involved in data collection and outcome assessment, including measurement assessors and the data analyst, will be blinded to group assignments. The principal investigator and healthcare personnel (physicians, physiotherapists, or trainers) who interact directly with participants will be aware of the group allocation. The Data Safety and Monitoring Committee and personnel preparing the manuscript will also remain blinded to group assignments. This design minimizes potential bias during data collection and analysis.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Payame Noor University
Street address
Payame Noor University, Nakhl St., Artesh Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
193954697
Approval date
2024-12-20, 1403/09/30
Ethics committee reference number
IR.PNU.REC.1403.539

Health conditions studied

1

Description of health condition studied
Gluteal muscle dysfunction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
- Gluteal muscle strength (abduction, external rotation, hip extension) will be measured using a dynamometer.
Timepoint
Before the intervention and after the 12-week exercise program
Method of measurement
Dynamometer

2

Description
Gluteal muscle endurance will be measured as the single-leg bridge hold time.
Timepoint
Before the intervention and after the 12-week exercise program
Method of measurement
Timer to measure the duration of the single-leg bridge hold

3

Description
Static and dynamic knee valgus will be assessed by measuring Q-angle and femur–tibia angle during standing and single-leg squat
Timepoint
Before the intervention and after the 12-week exercise program
Method of measurement
Goniometer or video analysis software to measure angles

Secondary outcomes

1

Description
Hip joint flexibility will be assessed by measuring range of motion in abduction and external rotation
Timepoint
Before the exercise program and after the 12-week intervention
Method of measurement
Goniometer to measure joint angles

2

Description
Static balance will be assessed using the single-leg stance test measuring the duration of balance
Timepoint
Before the exercise program and after the 12-week intervention
Method of measurement
Timer to record single-leg stance duration

Intervention groups

1

Description
Intervention group 1 – Local corrective exercise: Participants will follow a 12-week program of exercises focused on gluteal muscles. Sessions will be conducted three times per week under researcher supervision.
Category
Rehabilitation

2

Description
Intervention group 2 – Comprehensive corrective exercise: Participants will follow a 12-week program of exercises targeting the lower limbs and gluteal muscles. Sessions will be conducted three times per week under researcher supervision.
Category
Rehabilitation

3

Description
Control group: Participants will continue their usual daily activities without receiving any specific exercise program.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Zarban Fitness Club
Full name of responsible person
Fatemeh Eskandarian
Street address
No. 40, Sayad Street, Manzarieh Square
City
Gorgan
Province
Golestan
Postal code
۴۱۴۷۶۵۴۹۱۹
Phone
+98 911 644 5549
Email
zarabaan_gym@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Payame Noor University
Full name of responsible person
ِDr. Majid Zamahni
Street address
Payame Noor University, Nakhl St, Artesh Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
193954697
Phone
+98 21 2332 0000
Email
zamahani@pnu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Payame Noor 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
Payame Noor University
Full name of responsible person
Afshin Moghadasi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports Injury and Corrective Exercises
Street address
Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Tehran Province, Iran
City
Tehran
Province
Tehran
Postal code
193954697
Phone
+98 21 2332 0000
Email
moghadasi@pnu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
Afshin Moghadasi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports Injury and Corrective Exercises
Street address
Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Tehran Province, Iran
City
Tehran
Province
Tehran
Postal code
193954697
Phone
+98 21 2332 0000
Email
moghadasi@pnu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
Afshin Moghadasi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports Injury and Corrective Exercises
Street address
Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Tehran Province, Iran
City
Tehran
Province
Tehran
Postal code
193954697
Phone
+98 21 2332 0000
Email
moghadasi@pnu.ac.ir

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
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
Individual participant data (IPD) from the study, after de-identification to ensure participant privacy, will be shared upon reasonable request with researchers for secondary analyses related to gluteal muscle function and knee valgus. The data will include primary and secondary outcomes, demographic information, and relevant clinical measures.
When the data will become available and for how long
Access to the data and documents will begin after the completion of the study and the publication of the main results. Data preparation will include de-identification of participants’ information. Access is expected to be available to interested researchers six months after publication of the results and will continue indefinitely.
To whom data/document is available
Access to the data and documents will be granted to researchers interested in scientific and secondary analyses. Requests for access should include a description of the intended research purpose and type of analysis. The data will not be available for direct commercial use and will be shared only for legitimate scientific research purposes.
Under which criteria data/document could be used
The study data and documents may be used solely for scientific research and secondary analyses related to gluteal muscle function and knee valgus. Applicants must provide a written description of the research purpose and proposed analyses. Direct commercial use of the data is not permitted. Individual participant data will be de-identified to protect privacy. Applicants are required to use the data only for the approved purposes and must not publish results without permission.
From where data/document is obtainable
Applicants requesting access to study data and documents should contact the Principal Investigator: Name: Dr. Afshin Moghadasi Department: Department of Sports Injury and Corrective Exercises Institution: Payame Noor University (PNU) P.O. Box: 19395-4697, Tehran, Iran Email: moghadasi@pnu.ac.ir Phone: +98 918 943 2264 Please include in your email or correspondence a description of the research purpose and proposed analyses so that your request can be evaluated.
What processes are involved for a request to access data/document
1. The applicant should submit a written request via email to the Principal Investigator. 2. The request must clearly describe the research purpose, proposed analyses, and the specific data or documents needed. 3. The Principal Investigator will review the request and, if approved, a Data Use Agreement outlining the terms of use will be sent to the applicant. 4. After signing and returning the agreement, the de-identified data and documents will be prepared and provided to the applicant. 5. The entire process typically takes 2 to 4 weeks after a complete and valid request, depending on the volume of data and complexity of the request.
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