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IRCT20180627040251N6 IRCT 2023-08-01 Kharazmi University Comparison the Effect of lower limb resistance exercises with and without blood flow restriction on muscle strength, balance, and knee proprioception, in people with patellofemoral pain syndrome Effect of lower limb resistance exercises with and without blood flow restriction on muscle strength, balance, and knee proprioception, in people with patellofemoral pain syndrome 2023-08-16 anticipated 45 Complete https://irct.ir/trial/70989 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomized into one of three groups (Two interventions and one control) using an online randomization system (randomizer.org). A member of the research team who is not involved in the selection of samples will determine the randomization sequence using a computer program. Participants will be notified of their group allocation with a sealed envelope, Blinding description: In this study, the outcome assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, they do not make mistakes in their judgments in favor of a specific therapeutic intervention. N/A Condition 1: Knee pain. Condition 2: Patellofemoral disorders. Intervention 1: The first intervention group: This group includes patients with anterior knee pain (patellofemoral pain syndrome) who are found to be treatable with physical therapy after initial examination. This group of patients has the ability to perform movements as determined by their doctor. The exercises of these people include strength exercises (front leg machine, machine leg press) with 30% of the maximum strength, which are performed with 60% arterial occlusion pressure, by closing a pneumatic cuff around the thigh for 8 weeks and 3 times a week. The exercises of this group are one set of 30 repetitions (or voluntary exhaustion), then three sets of 15 repetitions. Also, rest between sets is 30 seconds and between exercises is 2 minutes. Intervention 2: The second intervention group: This group includes patients with anterior knee pain (patellofemoral pain syndrome) who, after the initial examination, have been determined to be treatable with physiotherapy. This group of patients has the ability to perform movements as determined by their doctor. Exercises in this group include strength training (front leg press, machine leg press) with three sets of 7 to 10 repetitions (approximately 70% of 1RM) with BFR placebo. The placebo is a 5 cm elastic cuff that is placed tightly (with enough space for two fingers between the skin and the cuff) around the proximal thigh. This does not affect the number of repetitions performed during strength training in the initial test. Rest between sets is 30 seconds and between exercises is 2 minutes. Intervention 3: Control group: In the control group, there is no intervention and only pre-test and post-test are taken. They are asked not to exercise during this time. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not necessary to publish this information
public Hassan Sadeghi
Mirdamad - Shahid Hesari St. - Shahid Keshvari Complex - Faculty of Physical Education and Sports Sciences
Tehran Iran (Islamic Republic of) 33111-15447 +98 21 2222 8001 hassan.sadeghi81@yahoo.com Kharazmi University scientific Hassan Sadeghi
Mirdamad - Shahid Hesari St. - Shahid Keshvari Complex - Faculty of Physical Education and Sports Sciences
Tehran Iran (Islamic Republic of) 33111-15447 +98 21 2222 8001 hassan.sadeghi81@yahoo.com Kharazmi University Iran (Islamic Republic of) Men and women between the ages of 18 and 40 with femoral patellofemoral pain syndrome pain with any activity, including (running, jumping, squatting, kneeling, climbing/descending stairs, or long sitting) pain with patellar pressure; Touching the area around the patella Pain in sitting position with resistance to isometric knee extension Positive Patellar grinding test 18 years 40 years Both Having an injury around the knee, including a laxity or dislocation of the patella Knee ligament and meniscus injuries Other knee injuries such as osteoarthritis of the knee, Osgoodschlatter syndrome or Sinding-Larsen-Johnson or tendinopathy of the muscles around the knee M22.2 M22.2 Patellofemoral disorders Rehabilitation Rehabilitation Placebo The first intervention group: This group includes patients with anterior knee pain (patellofemoral pain syndrome) who are found to be treatable with physical therapy after initial examination. This group of patients has the ability to perform movements as determined by their doctor. The exercises of these people include strength exercises (front leg machine, machine leg press) with 30% of the maximum strength, which are performed with 60% arterial occlusion pressure, by closing a pneumatic cuff around the thigh for 8 weeks and 3 times a week. The exercises of this group are one set of 30 repetitions (or voluntary exhaustion), then three sets of 15 repetitions. Also, rest between sets is 30 seconds and between exercises is 2 minutes. The second intervention group: This group includes patients with anterior knee pain (patellofemoral pain syndrome) who, after the initial examination, have been determined to be treatable with physiotherapy. This group of patients has the ability to perform movements as determined by their doctor. Exercises in this group include strength training (front leg press, machine leg press) with three sets of 7 to 10 repetitions (approximately 70% of 1RM) with BFR placebo. The placebo is a 5 cm elastic cuff that is placed tightly (with enough space for two fingers between the skin and the cuff) around the proximal thigh. This does not affect the number of repetitions performed during strength training in the initial test. Rest between sets is 30 seconds and between exercises is 2 minutes. Control group: In the control group, there is no intervention and only pre-test and post-test are taken. They are asked not to exercise during this time. Muscle strength. Timepoint: immediately before intervention; immediately after intervention. Method of measurement: Dynamometer. Balance. Timepoint: before intervention; immediately after intervention. Method of measurement: Biodex Balance System. Knee proprioception. Timepoint: before intervention; immediately after intervention. Method of measurement: Goniometer. Visual Analogue Scale. Timepoint: before intervention; immediately after intervention. Method of measurement: Score of 100 mm visual analog scale to assess pain intensity. Kharazmi University Approved 2023-06-21 Sport Sciences Research Institute (SSRI) No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)