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IRCT20250519065806N1 IRCT 2025-05-27 Deputy for research affairs, faculty of health University of Tehran Effect of 6-week TRX exercises for ACLR Effectiveness of six weeks TRX exercises on functional movement screen test, landing and dynamic balance in athletes with a history of anterior cruciate ligament reconstruction: a randomized control trial 2025-05-21 anticipated 26 Complete https://irct.ir/trial/83680 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After baseline measurements, participants will receive unique individual codes (numerical identifiers). Intervention group (INT): Participants with even-numbered codes. Control group (CON): Participants with odd-numbered codes. Codes are placed in sealed, opaque envelopes to ensure allocation concealment. Neither participants nor researchers involved in outcome assessments or data analysis will know group assignments (double-blind design). A research assistant will generate the randomization sequence using a computerized program. Allocation results will be securely stored in sealed envelopes and distributed to participants, Blinding description: Outcome assessor and data and statistical analyzer will be blinded from knowing intervention groups. This individual, a physiotherapist, is blinded to group allocation and is unaware of which participants belong to the intervention group and which belong to the control group. 3 Anterior cruciate ligament reconstruction. Intervention 1: Intervention Group: TRX Exercises. After obtaining the ethical approval code, athletes with a history of anterior cruciate ligament reconstruction who underwent surgery under the supervision of Dr. Mohammadreza Sobhan, and at least 9 months have passed since their reconstruction surgery, will be invited to participate in this study. To invite participants, the researcher will visit the physician’s office and, after reviewing the medical records of individuals who have undergone ACL reconstruction, will select samples for this study based on the inclusion and exclusion criteria. These criteria will be evaluated through contact with the individuals. Based on the sample size assessment and their initial willingness to participate, the study’s objectives and the potential positive and negative outcomes of participation will be explained to them. They will also be assured that they can withdraw from the study at any stage if they no longer wish to continue. Then, the informed consent form will be provided to those who confirm their willingness to participate, and they will be asked to sign it. Following this, demographic information including age, weight, height, history of sports activity, type of sport, duration of sports participation before injury (number of sessions per week), and injury history will be collected through face-to-face interviews. In this study, the Functional Movement Screen (FMS) test will be used to assess motor performance. Landing mechanics and dynamic balance will be measured using the Landing Error Scoring System (LESS) and the Y-Balance Test, respectively. Before starting the exercises, a pre-test will be conducted for all participants in the intervention group, with the order of the pre-test standardized for all individuals. Participants in the intervention group will perform TRX exercises for 6 weeks, with 3 sessions per week. The exercise program for this study was adapted from the study by You et al. At the beginning of each training session, participants will perform a 10-minute warm-up. Additionally, a 5-minute cool-down will be conducted after the exercises. After completing the training program, a post-test identical to the pre-test will be administered to all participants, and the results will be recorded, reviewed, and evaluated. Intervention 2: Control group: no intervention. After obtaining the ethical approval code, athletes with a history of anterior cruciate ligament reconstruction who underwent surgery under the supervision of Dr. Mohammadreza Sobhan, and at least 9 months have passed since their reconstruction surgery, will be invited to participate in this study. To invite participants, the researcher will visit the physician’s office and, after reviewing the medical records of individuals who have undergone ACL reconstruction, will select samples for this study based on the inclusion and exclusion criteria. These criteria will be evaluated through contact with the individuals. Based on the sample size assessment and their initial willingness to participate, the study’s objectives and the potential positive and negative outcomes of participation will be explained to them. They will also be assured that they can withdraw from the study at any stage if they no longer wish to continue. Then, the informed consent form will be provided to those who confirm their willingness to participate, and they will be asked to sign it. Following this, demographic information including age, weight, height, history of sports activity, type of sport, duration of sports participation before injury (number of sessions per week), and injury history will be collected through face-to-face interviews. In this study, the Functional Movement Screen (FMS) test will be used to assess motor performance. Landing mechanics and dynamic balance will be measured using the Landing Error Scoring System (LESS) and the Y-Balance Test, respectively. Before starting the exercises, a pre-test will be conducted for all participants in the control group, with the order of the pre-test standardized for all individuals. In the control group, no intervention will be performed for 6 weeks, and individuals will continue their normal daily activities. Yes - There is a plan to make this available What will be shared: There is no further information When: 3 month after publication To whom: everyone Conditions: For research and rehabilitation Where to obtain: Email How to obtain: One week time to gather the needed data Comments:
public Seyed Hamed Musavi
17 north kargar
Tehran Iran (Islamic Republic of) 1664918948 +98 21 6111 8807 musavihamed@ut.ac.ir University of Tehran scientific Mostafa Jalili Bafrouei
17th north kargar
Tehran Iran (Islamic Republic of) 1664918948 +98 21 9109 9511 m.jalili.b@ut.ac.ir University of Tehran Iran (Islamic Republic of) Willingness to participate in the intervention Male gender Age between 14 and 40 years Having at least three years of sports activity experience Engaging in regular sports activity, with 3 sessions per week before the injury History of anterior cruciate ligament (ACL) reconstruction surgery, with at least 9 months elapsed since the operation Completion of rehabilitation stages Use of Arthrex graft 14 years 40 years Male History of previous ACL injury Bone fracture associated with ACL injury Significant injury other than ACL Uncontrolled diabetes or high blood pressure Failure to participate in more than 2 training sessions S83.5 Sprain of cruciate ligament of knee Rehabilitation Rehabilitation Intervention Group: TRX Exercises. After obtaining the ethical approval code, athletes with a history of anterior cruciate ligament reconstruction who underwent surgery under the supervision of Dr. Mohammadreza Sobhan, and at least 9 months have passed since their reconstruction surgery, will be invited to participate in this study. To invite participants, the researcher will visit the physician’s office and, after reviewing the medical records of individuals who have undergone ACL reconstruction, will select samples for this study based on the inclusion and exclusion criteria. These criteria will be evaluated through contact with the individuals. Based on the sample size assessment and their initial willingness to participate, the study’s objectives and the potential positive and negative outcomes of participation will be explained to them. They will also be assured that they can withdraw from the study at any stage if they no longer wish to continue. Then, the informed consent form will be provided to those who confirm their willingness to participate, and they will be asked to sign it. Following this, demographic information including age, weight, height, history of sports activity, type of sport, duration of sports participation before injury (number of sessions per week), and injury history will be collected through face-to-face interviews. In this study, the Functional Movement Screen (FMS) test will be used to assess motor performance. Landing mechanics and dynamic balance will be measured using the Landing Error Scoring System (LESS) and the Y-Balance Test, respectively. Before starting the exercises, a pre-test will be conducted for all participants in the intervention group, with the order of the pre-test standardized for all individuals. Participants in the intervention group will perform TRX exercises for 6 weeks, with 3 sessions per week. The exercise program for this study was adapted from the study by You et al. At the beginning of each training session, participants will perform a 10-minute warm-up. Additionally, a 5-minute cool-down will be conducted after the exercises. After completing the training program, a post-test identical to the pre-test will be administered to all participants, and the results will be recorded, reviewed, and evaluated Control group: no intervention. After obtaining the ethical approval code, athletes with a history of anterior cruciate ligament reconstruction who underwent surgery under the supervision of Dr. Mohammadreza Sobhan, and at least 9 months have passed since their reconstruction surgery, will be invited to participate in this study. To invite participants, the researcher will visit the physician’s office and, after reviewing the medical records of individuals who have undergone ACL reconstruction, will select samples for this study based on the inclusion and exclusion criteria. These criteria will be evaluated through contact with the individuals. Based on the sample size assessment and their initial willingness to participate, the study’s objectives and the potential positive and negative outcomes of participation will be explained to them. They will also be assured that they can withdraw from the study at any stage if they no longer wish to continue. Then, the informed consent form will be provided to those who confirm their willingness to participate, and they will be asked to sign it. Following this, demographic information including age, weight, height, history of sports activity, type of sport, duration of sports participation before injury (number of sessions per week), and injury history will be collected through face-to-face interviews. In this study, the Functional Movement Screen (FMS) test will be used to assess motor performance. Landing mechanics and dynamic balance will be measured using the Landing Error Scoring System (LESS) and the Y-Balance Test, respectively. Before starting the exercises, a pre-test will be conducted for all participants in the control group, with the order of the pre-test standardized for all individuals. In the control group, no intervention will be performed for 6 weeks, and individuals will continue their normal daily activities Dynamic balance, landing mechanism, functional movement screen. Timepoint: First week and after 6 weeks. Method of measurement: Y-balance test, Landing Error Screen System, Functional Movement Screen Test. Deputy for research affairs, faculty of health University of Tehran Approved 2023-07-11 Ethics committee of faculty of sport science and health, university of Tehran North kargar street, faculty of sport science and health, university of Tehran Tehran Tehran Iran (Islamic Republic of)