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
Evaluating the effectiveness of 6 weeks of TRX training on the functional movement screening test, landing mechanics, and dynamic balance in athletes with a history of anterior cruciate ligament reconstruction.
Design
A controlled clinical trial with parallel groups, single-blind, randomized, phase 3, conducted on 26 patients. Computer software was used for randomization
Settings and conduct
Athletes with a history of anterior cruciate ligament reconstruction who underwent surgery under the supervision of Dr. Mohammadreza Sobhan and had at least 9 months elapsed since their reconstruction surgery were invited to participate in this study
Participants/Inclusion and exclusion criteria
Being male, completion of the rehabilitation program, more than 9 months elapsed since ACLR
Intervention groups
Intervention group: TRX exercises
Control group: Did not receive any training
Main outcome variables
Scores of the Functional Movement Screen (FMS) test; landing mechanics; dynamic balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250519065806N1
Registration date:2025-05-27, 1404/03/06
Registration timing:registered_while_recruiting
Last update:2025-05-27, 1404/03/06
Update count:0
Registration date
2025-05-27, 1404/03/06
Registrant information
Name
Mostafa Jalili Bafrouei
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8837 2580
Email address
m.jalili.b@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-21, 1404/02/31
Expected recruitment end date
2025-06-20, 1404/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of 6-week TRX exercises for ACLR
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 14 years old to 40 years old
Gender
Male
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
26
More than 1 sample in each individual
Number of samples in each individual:
1
ACLR data of knee function
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of faculty of sport science and health, university of Tehran
Street address
North kargar street, faculty of sport science and health, university of Tehran
City
Tehran
Province
Tehran
Postal code
1664918948
Approval date
2023-07-11, 1402/04/20
Ethics committee reference number
IR.UT.SPORT.REC.1402.051
Health conditions studied
1
Description of health condition studied
Anterior cruciate ligament reconstruction
ICD-10 code
S83.5
ICD-10 code description
Sprain of cruciate ligament of knee
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Rehabilitation
2
Description
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
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
َArvand physiotherapy
Full name of responsible person
Mostafa Jalili Bafrouei
Street address
No 64, Darya Ave, Sa'adat abad Blvd
City
Tehran
Province
Tehran
Postal code
1466983465
Phone
+98 21 8837 2580
Email
jalilimostafa3@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy for research affairs, faculty of health University of Tehran
Full name of responsible person
Seyed Hamed Mousavi
Street address
17th Kargar
City
Tehran
Province
Tehran
Postal code
1664918948
Phone
+98 21 6111 8807
Email
Hamedmusavi@ut.ac.ir
Grant name
Seyed Hamed Mousavi
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for research affairs, faculty of health University of Tehran
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
University of Tehran
Full name of responsible person
Seyed Hamed Musavi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
17 north kargar
City
Tehran
Province
Tehran
Postal code
1664918948
Phone
+98 21 6111 8807
Email
musavihamed@ut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Mostafa Jalili Bafrouei
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
17th north kargar
City
Tehran
Province
Tehran
Postal code
1664918948
Phone
+98 21 9109 9511
Email
m.jalili.b@ut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Mostafa Jalili Bafrouei
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
17th north kargar
City
Tehran
Province
Tehran
Postal code
1466983465
Phone
+98 21 9109 9511
Email
m.jalili.b@ut.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
There is no further information
When the data will become available and for how long
3 month after publication
To whom data/document is available
everyone
Under which criteria data/document could be used
For research and rehabilitation
From where data/document is obtainable
Email
What processes are involved for a request to access data/document