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IRCT20180521039762N5 IRCT 2026-02-05 Payame Noor University Effect of Corrective Exercises on Knee Valgus and Gluteal Muscle Function in Women The Effects of Comprehensive and Localized Corrective Exercises on Knee Valgus and Gluteal Muscle Strength and Endurance in Women with Gluteal Muscle Dysfunction 2026-02-06 anticipated 45 Complete https://irct.ir/trial/88664 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. N/A Gluteal muscle dysfunction. Intervention 1: 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. Intervention 2: 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. Intervention 3: Control group: Participants will continue their usual daily activities without receiving any specific exercise program. Yes - There is a plan to make this available What will be shared: 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: 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: 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. Conditions: 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. Where to obtain: 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. How to obtain: 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. Comments:
public Afshin Moghadasi
Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Tehran Province, Iran
Tehran Iran (Islamic Republic of) 193954697 +98 21 2332 0000 moghadasi@pnu.ac.ir Payame Noor University scientific Afshin Moghadasi
Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Tehran Province, Iran
Tehran Iran (Islamic Republic of) 193954697 +98 21 2332 0000 moghadasi@pnu.ac.ir Payame Noor University Iran (Islamic Republic of) 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 18 years 50 years Female 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 Rehabilitation Rehabilitation N/A 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. 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. Control group: Participants will continue their usual daily activities without receiving any specific exercise program. - 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. 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. 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. 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. 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. Payame Noor University Approved 2024-12-20 Research Ethics Committees of Payame Noor University Payame Noor University, Nakhl St., Artesh Blvd., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)