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IRCT20101228005486N6 IRCT 2019-05-20 Iran University of Medical Sciences Therapeutic exercise in knee osteoarthritis Comparison of the short-term effects of two exercise programmes on pain, thigh ‎muscles atrophy, function and the thickness of Vastos Medialis and Lateralis in ‎patients with knee osteoarthritis‏.‏ 2019-02-20 anticipated 82 Complete https://irct.ir/trial/36494 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation of the subjects was done by using a block random sampling; A: Proposed Exercise Therapy Group ‎( PET )‎ B: Conventional Exercise Therapy Group( CET) ‎ ‎-‎ Block ‎‏1‏‎: AABB‎ ‎-‎ Block ‎‏2‏‎: ABAB‎ ‎-‎ Block ‎‏3‏‎: BBAA‎ ‎-‎ Block ‎‏4‏‎: BABA‎ ‎-‎ Block ‎‏5‏‎: ABBA‎ ‎-‎ Block ‎‏6‏‎: BAAB‎, Blinding description: In this study, the assessor will be blinded to the study groups. The outcomes will be evaluated pre and post intervention by a sports medicine assistant who will be blind to the presence of patients in the groups.about the presence of patients in the groups. Furthermore, the sonography of thigh muscles is done by a sports medicine specialist who will not be aware of the patient groups. Similarly, the data obtained from the study will be analyzed by a statistician who is not aware of the patient groups. N/A Primary knee osteoarthritis. Intervention 1: Intervention or Proposed Exercise Therapy Group‎ (PETG): The exercises protocol proposed for the patients with knee osteoarthritis (KOA) is designed based on the studies that all seek to find the best way to strengthen the quadriceps femoris by employing positions in which there is a selective Vastus Medialis Oblique (VMO) activity. It's worth noting that the researchers have not yet had a consensus on this condition, and this is why the study will try to examine the impact of these positions on KOA patients. 1. Straight legs raising (SLR) in a sitting position (while leaning against the wall) with ankle dorsiflexion - for each leg in the first two weeks, which will be done in two sets of 10 repetitions in each session with five second-hold. In the second two weeks, it will be done in three sets. 2. Straight legs raising (SLR) in a sitting position with the external rotation of the thigh and a five second hold - for each leg in the first two weeks will be done in two sets of 10 in each session. In the second two weeks, it will be done in three sets ten repetition. In the first week of this exercise will be done without any resistance, and after the second week a suitable weight cuff will be added. 3. Straight legs raising (SLR)with ankle dorsiflexion - The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks, with a five-second hold. In the second two weeks, it will increase to three sets. To do this exercise, the patient is asked to lie supine while one of the knees is bent, then do SLR. In the first week of this will be done without any resistance in three sets of ten, and after the second week a suitable weight cuff will be added. 4. Static contraction of the quadriceps femoris in a standing position - The patient is asked to stand in the front of a wall, with a flexible ball behind his knee, the patient is asked to statically contract the thigh muscles and push the ball to the wall. It will be done for each leg in the first two weeks in two sets of 10 repetitions and in the last two weeks in three .the duration of static contraction is 5 seconds. 5. Static contraction of the quadriceps femoris with ankle dorsiflexion – It will be performed in two sets of 10 repetitions for each leg in the first two weeks with a five-second hold. In the second two weeks, the exercise sets will be increased to three. The patient is asked to statically contract the thigh muscles with ankle dorsiflexion while a small pillow is under the patient's knee. 6. Straight legs raising (SLR) along with the hip adduction- The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. To do this exercise, the patient is asked to lie supine, and then do SLR with hip adduction. In the first week of the exercise will be done without any resistance and after the second 2-week a suitable weight cuff will be added. 7. Straight legs raising (SLR) along with the hip external rotation-The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold.In the second two weeks, the exercise sets will be increased to three.To do this exercise, the patient is asked to lie supine, and then do SLR with hip external rotation.In the first week of the exercise will be done without any resistance and after the second 2-week a suitable weight cuff will be added. 8. Static contraction of hip adductors-The exercise will be done in two sets of 10 repetitions for the legs in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 9. The resisted exercise of the quadriceps femoris with ankle dorsiflexion- After determining the proper weight, the exercise will be done in a set with 10 repetitions and the duration of holding it will be 5 seconds, which will be accompanied by the ankle dorsiflexion. In the second week , it will be done in two sets of 10 repetition, and in the last two weeks, it will increase to three sets. 10. Terminal knee extension with theraband- The patient is asked to stand while theraband is around his knee; when the theraband pulls the knee forward, the patient should try to extend the knee at the terminal range. In the first two weeks, it will be done in two sets of 10 repetitions and in the last two weeks, it will be increased to three sets. 11. Leg press-The patient is asked to sit on leg press machine while pushing a pillow which is between the thighs and press leg at the terminal 30 degrees of the extension. In the first week, it will be done in one set of 10 repetitions, in the second week it will be done in two sets of 10 repetitions and in the last two weeks, it will be increased to three sets. 12. Heel drop - The patient is asked to stand in front of a step to a height of 30 cm and step up and down for each leg in three direction; front, lateral and back.In the first week, it will be done in one set of 10 repetitions, in the second week it will be done in two sets of 10 repetitions and in the last two weeks, it will be increased to three sets. 13. Mini squat with isometric hip adduction -The patient is asked to do mini squat while pushing a ball between the thighs.In the first two weeks,it will be done in two sets of 10 repetitions and in the last two weeks, it will be increased to three sets. 14. Mini squat on a wedge - The patient is asked to do mini squat while standing on a ramp (30 degrees slope). In the first two weeks,it will be done in two sets of 10 repetitions and in the last two weeks, it will be increased to three sets. 15. Forward lunge - The patient is asked to do forward lunge.In the first week, it will be done in one sets of 10 repetitions,in the second week it will be done in two set of 10 repetitions and in the last two weeks, it will be increased to three sets. Intervention 2: Control group: Exercise protocol for patients with knee osteoarthritis for patients in the control group - 1. Straight legs raising (SLR) in a supine position - It will be done for each leg in two sets of 10 repetitions in each session in the first two weeks and keeping SLR with a five- second hold. In the second two weeks, it will be done in three sets. 2. Straight legs raising (SLR) with weight cuff - It will be done for each leg in two sets of 10 in each session in the first two weeks with a five-second hold, In the second two weeks, it will be done in three sets of 10 repetitions. In the first week, this exercise will be done without any resistance, and after the second week, a suitable weight cuff will be added. 3. Static contraction of the quadriceps femoris in a supine position - The patient is asked to lie in the supine position and statically contract the thigh muscles. It will be done for each leg in the first two weeks in two sets of 10 repetitions and in the last two weeks in three sets of 10 repetitions. The duration of static contraction is 5 seconds. 4. Static contraction of hip adductors- The exercise will be done in two sets of 10 repetitions for the legs in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 5.Heel raising - The exercise will be done in two sets of 10 repetitions for the legs in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 6. Standing on one leg-The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 7. Step up-The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 8. Leg cross-The patient is asked to sit on the chair and put one leg on the other, then extend the back leg; the exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 9.Sit to stand- The patient is asked to sit on the chair and get up while the hands on the chest and sit back on the chair. The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 10. The resisted exercise of the quadriceps femoris- After determining the proper weight, the exercise will be done in a set with 10 repetitions and the duration of holding it will be 5 seconds. In the second week, it will be done in two sets of 10 repetitions, and in the last two weeks, it will increase to three sets. 11. Reverse Straight legs raising (SLR)-The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. To do this exercise, the patient is asked to lie prone and then do SLR. 12. Sit to stand with the hip abduction-The patient is asked to sit on the chair and get up while the hands on the chest and the hips are abducted as wide as shoulder and sit back on the chair. The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 13. Standing Hip Abduction- The patient is asked to stand next to a chair while taking a chair with one of the hands, lifting one of the legs, and doing the hip abduction. The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 14. Standing Hip Adduction- The patient is asked to stand next to a chair while taking a chair with one of the hands, lifting one of the legs, and doing the hip adduction. The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 15. Standing Leg Curl- The patient is asked to stand next to a chair while taking a chair with one of the hands, lifting one of the legs, and doing the knee flexion. The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to ethical standards, The participants have been promised that the information of this research will remain confidential in their written consent form.
public Sahar Kavand
Sports Medicine Department, Hazrat Rasool Akram Hospital, Niayesh St, Sattarkhan .
Tehran Iran (Islamic Republic of) 14455613131 +98 21 6435 2446 sahar_kawand@yahoo.com Iran University of Medical Sciences scientific Dr Azar Moezy
Sports Medicine Department, Hazrat Rasool Akram Hospital, Niayesh St, Sattarkhan Ave.
Tehran Iran (Islamic Republic of) 14455613131 +98 21 6435 2446 moezy.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Primary OA of the knee joint grade 2, 3 according Kellgren and Lawrence scale; ّFemale gender; Age between 50-75; Suffering from knee pain for at least six months and with intensity 3 on the VAS scale in activities such as getting up and down stairs, sitting and squat; No history of knee intra-articular injection in the past six months; Referral from a specialist; No history of acute traumatic injuries approved by the referral physician; No history of previous surgery or injury in the knee joints and lower extremities; BMI equal or less than 30; Patient's consent to participate in the research; Normal mental state; 50 years 75 years Female History of neuromuscular disease; Bone implants, History of new fractures in lower limbs; Participating in exercise therapy and physical therapy programs in the recent three months. History of chronic disease and generally any disease or conditions that known to affect the investigation; Malignant tumors; M17.0 - M1 Gonarthrosis [arthrosis of the knee] Rehabilitation Rehabilitation Intervention or Proposed Exercise Therapy Group‎ (PETG): The exercises protocol proposed for the patients with knee osteoarthritis (KOA) is designed based on the studies that all seek to find the best way to strengthen the quadriceps femoris by employing positions in which there is a selective Vastus Medialis Oblique (VMO) activity. It's worth noting that the researchers have not yet had a consensus on this condition, and this is why the study will try to examine the impact of these positions on KOA patients. 1. Straight legs raising (SLR) in a sitting position (while leaning against the wall) with ankle dorsiflexion - for each leg in the first two weeks, which will be done in two sets of 10 repetitions in each session with five second-hold. In the second two weeks, it will be done in three sets. 2. Straight legs raising (SLR) in a sitting position with the external rotation of the thigh and a five second hold - for each leg in the first two weeks will be done in two sets of 10 in each session. In the second two weeks, it will be done in three sets ten repetition. In the first week of this exercise will be done without any resistance, and after the second week a suitable weight cuff will be added. 3. Straight legs raising (SLR)with ankle dorsiflexion - The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks, with a five-second hold. In the second two weeks, it will increase to three sets. To do this exercise, the patient is asked to lie supine while one of the knees is bent, then do SLR. In the first week of this will be done without any resistance in three sets of ten, and after the second week a suitable weight cuff will be added. 4. Static contraction of the quadriceps femoris in a standing position - The patient is asked to stand in the front of a wall, with a flexible ball behind his knee, the patient is asked to statically contract the thigh muscles and push the ball to the wall. It will be done for each leg in the first two weeks in two sets of 10 repetitions and in the last two weeks in three .the duration of static contraction is 5 seconds. 5. Static contraction of the quadriceps femoris with ankle dorsiflexion – It will be performed in two sets of 10 repetitions for each leg in the first two weeks with a five-second hold. In the second two weeks, the exercise sets will be increased to three. The patient is asked to statically contract the thigh muscles with ankle dorsiflexion while a small pillow is under the patient's knee. 6. Straight legs raising (SLR) along with the hip adduction- The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. To do this exercise, the patient is asked to lie supine, and then do SLR with hip adduction. In the first week of the exercise will be done without any resistance and after the second 2-week a suitable weight cuff will be added. 7. Straight legs raising (SLR) along with the hip external rotation-The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold.In the second two weeks, the exercise sets will be increased to three.To do this exercise, the patient is asked to lie supine, and then do SLR with hip external rotation.In the first week of the exercise will be done without any resistance and after the second 2-week a suitable weight cuff will be added. 8. Static contraction of hip adductors-The exercise will be done in two sets of 10 repetitions for the legs in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 9. The resisted exercise of the quadriceps femoris with ankle dorsiflexion- After determining the proper weight, the exercise will be done in a set with 10 repetitions and the duration of holding it will be 5 seconds, which will be accompanied by the ankle dorsiflexion. In the second week , it will be done in two sets of 10 repetition, and in the last two weeks, it will increase to three sets. 10. Terminal knee extension with theraband- The patient is asked to stand while theraband is around his knee; when the theraband pulls the knee forward, the patient should try to extend the knee at the terminal range. In the first two weeks, it will be done in two sets of 10 repetitions and in the last two weeks, it will be increased to three sets. 11. Leg press-The patient is asked to sit on leg press machine while pushing a pillow which is between the thighs and press leg at the terminal 30 degrees of the extension. In the first week, it will be done in one set of 10 repetitions, in the second week it will be done in two sets of 10 repetitions and in the last two weeks, it will be increased to three sets. 12. Heel drop - The patient is asked to stand in front of a step to a height of 30 cm and step up and down for each leg in three direction; front, lateral and back.In the first week, it will be done in one set of 10 repetitions, in the second week it will be done in two sets of 10 repetitions and in the last two weeks, it will be increased to three sets. 13. Mini squat with isometric hip adduction -The patient is asked to do mini squat while pushing a ball between the thighs.In the first two weeks,it will be done in two sets of 10 repetitions and in the last two weeks, it will be increased to three sets. 14. Mini squat on a wedge - The patient is asked to do mini squat while standing on a ramp (30 degrees slope). In the first two weeks,it will be done in two sets of 10 repetitions and in the last two weeks, it will be increased to three sets. 15. Forward lunge - The patient is asked to do forward lunge.In the first week, it will be done in one sets of 10 repetitions,in the second week it will be done in two set of 10 repetitions and in the last two weeks, it will be increased to three sets. Control group: Exercise protocol for patients with knee osteoarthritis for patients in the control group - 1. Straight legs raising (SLR) in a supine position - It will be done for each leg in two sets of 10 repetitions in each session in the first two weeks and keeping SLR with a five- second hold. In the second two weeks, it will be done in three sets. 2. Straight legs raising (SLR) with weight cuff - It will be done for each leg in two sets of 10 in each session in the first two weeks with a five-second hold, In the second two weeks, it will be done in three sets of 10 repetitions. In the first week, this exercise will be done without any resistance, and after the second week, a suitable weight cuff will be added. 3. Static contraction of the quadriceps femoris in a supine position - The patient is asked to lie in the supine position and statically contract the thigh muscles. It will be done for each leg in the first two weeks in two sets of 10 repetitions and in the last two weeks in three sets of 10 repetitions. The duration of static contraction is 5 seconds. 4. Static contraction of hip adductors- The exercise will be done in two sets of 10 repetitions for the legs in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 5.Heel raising - The exercise will be done in two sets of 10 repetitions for the legs in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 6. Standing on one leg-The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 7. Step up-The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 8. Leg cross-The patient is asked to sit on the chair and put one leg on the other, then extend the back leg; the exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 9.Sit to stand- The patient is asked to sit on the chair and get up while the hands on the chest and sit back on the chair. The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 10. The resisted exercise of the quadriceps femoris- After determining the proper weight, the exercise will be done in a set with 10 repetitions and the duration of holding it will be 5 seconds. In the second week, it will be done in two sets of 10 repetitions, and in the last two weeks, it will increase to three sets. 11. Reverse Straight legs raising (SLR)-The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. To do this exercise, the patient is asked to lie prone and then do SLR. 12. Sit to stand with the hip abduction-The patient is asked to sit on the chair and get up while the hands on the chest and the hips are abducted as wide as shoulder and sit back on the chair. The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 13. Standing Hip Abduction- The patient is asked to stand next to a chair while taking a chair with one of the hands, lifting one of the legs, and doing the hip abduction. The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 14. Standing Hip Adduction- The patient is asked to stand next to a chair while taking a chair with one of the hands, lifting one of the legs, and doing the hip adduction. The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. 15. Standing Leg Curl- The patient is asked to stand next to a chair while taking a chair with one of the hands, lifting one of the legs, and doing the knee flexion. The exercise will be done in two sets of 10 repetitions for each leg in the first two weeks with a 5-second hold. In the second two weeks, the exercise sets will be increased to three. Pain. Timepoint: pre-intervention and post-intervention. Method of measurement: VAS pain scale. Active knee range of flexion. Timepoint: pre-intervention and post-intervention. Method of measurement: Goniometery. The circumference of the thigh. Timepoint: pre-intervention and post-intervention. Method of measurement: With centimeter tape. Thickness of the muscles of Vastus Lateralis and Medialis. Timepoint: pre-intervention and post-intervention. Method of measurement: Sonography. Functional Activity. Timepoint: Pre -intervention and Post -intervention. Method of measurement: Timed Up & Go Test and Six-Minute Walk Test. Iran University of Medical Sciences Approved 2018-05-22 Ethics Committee of Iran University of Medical Sciences Iran University Of Medical Sciences, Hemat Highway next to Milad Tower Tehran Tehran Iran (Islamic Republic of)