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IRCT20260613069777N1 IRCT 2026-08-17 Tehran University of Medical Sciences The effect of exercises with blood flow restriction on pain, muscle strength and function in people with osteoarthritis The effect of closed and open kinetic chain exercises combined with blood flow restriction therapy on pain, muscle strength, and function in patients with knee osteoarthritis 2026-09-11 anticipated 40 Recruiting https://irct.ir/trial/92255 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly allocated to two intervention groups in a 1:1 ratio using a computer-generated random sequence. Randomization will be performed using Random Allocation Software. Gender matching will be considered to ensure balanced distribution of male and female participants between the two groups. Allocation concealment will be maintained using sequentially numbered, sealed, opaque envelopes, Blinding description: The outcome assessor will be blinded to group allocation throughout the study. The assessor will perform the baseline and post-intervention outcome measurements without knowing whether each participant has been allocated to the closed kinetic chain exercise with blood flow restriction group or the open kinetic chain exercise with blood flow restriction group. The physiotherapist providing the intervention and the participants will not be blinded due to the nature of the exercise interventions. N/A Knee osteoarthritis. Intervention 1: Intervention group 1: Closed kinetic chain exercises combined with blood flow restriction (CKC+BFR). Participants will receive a supervised 4-week rehabilitation program consisting of 3 sessions per week (12 sessions in total). The closed kinetic chain exercise program will include squat-to-chair, step-up, and Swiss-ball leg press exercises. Blood flow restriction will be applied during exercise at 40–80% of the individually determined limb occlusion pressure (LOP). Exercises will be performed using a low load of 20–30% of one-repetition maximum (1RM), following a 30–15–15–15 repetition scheme with 30–40 seconds of rest between sets. Exercise load will be progressively increased according to participant tolerance while remaining within the prescribed low-load range. Each session will include a standardized warm-up consisting of 5 minutes of low-intensity stationary cycling or brisk walking followed by 2–3 minutes of gentle knee range-of-motion exercises. At the end of the session, participants will perform quadriceps and hamstring stretching, with each stretch held for 30 seconds and repeated twice. All sessions will be supervised by a licensed physiotherapist to ensure correct technique, safety, and adherence to the intervention protocol. Intervention 2: Intervention group 2: Open kinetic chain exercises combined with blood flow restriction (OKC+BFR). Participants will receive a supervised 4-week rehabilitation program consisting of 3 sessions per week (12 sessions in total). The open kinetic chain exercise program will include seated knee extension, straight leg raise, and hamstring curl exercises. Blood flow restriction will be applied during exercise at 40–80% of the individually determined limb occlusion pressure (LOP). Exercises will be performed using a low load of 20–30% of one-repetition maximum (1RM), following a 30–15–15–15 repetition scheme with 30–40 seconds of rest between sets. Exercise resistance will be progressively increased using external resistance such as ankle weights or elastic resistance bands according to participant tolerance while remaining within the prescribed low-load range. Each session will include a standardized warm-up consisting of 5 minutes of low-intensity stationary cycling or brisk walking followed by 2–3 minutes of gentle knee range-of-motion exercises. At the end of the session, participants will perform quadriceps and hamstring stretching, with each stretch held for 30 seconds and repeated twice. All sessions will be supervised by a licensed physiotherapist to ensure correct technique, safety, and adherence to the intervention protocol. Yes - There is a plan to make this available What will be shared: All data is potentially sharable after unidentified individuals. When: Access period starts 3 months after the article is published. To whom: For researchers working in academic, scientific and hospital institutions. Conditions: Researchers working in the field of knee osteoarthritis and exercise therapy. Where to obtain: Applicants for documentation can contact Dr. Attarbashi Moghadam via email: attarbashi@sina.tums.ac.ir How to obtain: Once they have the necessary criteria, the information will be provided to them within a month. Comments:
public Taqwa Salwan Alkhateeb
Alkharkh
Baghdad Iraq 10069 +964 781 294 2798 taqwa98.ts@gmail.com Tehran University of Medical Sciences scientific Behrouz Attarbashi Moghadam
School of Rehabilitation, Piche Shemiran, Enghelab Street
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 3939 attarbashi@sina.tums.ac.ir Tehran University of Medical Sciences Iraq Iraq Iraq Adults aged 45–60 years. Clinical and radiographic diagnosis of knee osteoarthritis, Kellgren–Lawrence grade II–III. Body mass index (BMI) between 25–35 kg/m². Knee pain intensity between 30–80 mm on a 100-mm Visual Analog Scale (VAS) during daily activities. Mild to moderate lower limb malalignment, defined as varus or valgus deformity ≤10°. Ability to walk independently with or without minimal assistive devices. Willingness to participate and provide written informed consent. 45 years 60 years Both History of total knee replacement surgery. Intra-articular corticosteroid or hyaluronic acid injection within the past 3 months. Uncontrolled hypertension, unstable angina, or recent myocardial infarction. Peripheral vascular disease, history of deep vein thrombosis (DVT), or clotting disorders. Neurological disorders affecting lower limb strength or mobility. Contraindications to blood flow restriction training, such as severe varicosities, vascular insufficiency, or severe edema. M17.9 Osteoarthritis of knee, unspecified Rehabilitation Rehabilitation Intervention group 1: Closed kinetic chain exercises combined with blood flow restriction (CKC+BFR). Participants will receive a supervised 4-week rehabilitation program consisting of 3 sessions per week (12 sessions in total). The closed kinetic chain exercise program will include squat-to-chair, step-up, and Swiss-ball leg press exercises. Blood flow restriction will be applied during exercise at 40–80% of the individually determined limb occlusion pressure (LOP). Exercises will be performed using a low load of 20–30% of one-repetition maximum (1RM), following a 30–15–15–15 repetition scheme with 30–40 seconds of rest between sets. Exercise load will be progressively increased according to participant tolerance while remaining within the prescribed low-load range. Each session will include a standardized warm-up consisting of 5 minutes of low-intensity stationary cycling or brisk walking followed by 2–3 minutes of gentle knee range-of-motion exercises. At the end of the session, participants will perform quadriceps and hamstring stretching, with each stretch held for 30 seconds and repeated twice. All sessions will be supervised by a licensed physiotherapist to ensure correct technique, safety, and adherence to the intervention protocol. Intervention group 2: Open kinetic chain exercises combined with blood flow restriction (OKC+BFR). Participants will receive a supervised 4-week rehabilitation program consisting of 3 sessions per week (12 sessions in total). The open kinetic chain exercise program will include seated knee extension, straight leg raise, and hamstring curl exercises. Blood flow restriction will be applied during exercise at 40–80% of the individually determined limb occlusion pressure (LOP). Exercises will be performed using a low load of 20–30% of one-repetition maximum (1RM), following a 30–15–15–15 repetition scheme with 30–40 seconds of rest between sets. Exercise resistance will be progressively increased using external resistance such as ankle weights or elastic resistance bands according to participant tolerance while remaining within the prescribed low-load range. Each session will include a standardized warm-up consisting of 5 minutes of low-intensity stationary cycling or brisk walking followed by 2–3 minutes of gentle knee range-of-motion exercises. At the end of the session, participants will perform quadriceps and hamstring stretching, with each stretch held for 30 seconds and repeated twice. All sessions will be supervised by a licensed physiotherapist to ensure correct technique, safety, and adherence to the intervention protocol. Pain intensity. Timepoint: Before the intervention and after completion of the 12-session intervention. Method of measurement: Pain intensity will be measured using a 100-mm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (worst imaginable pain). Quadriceps muscle strength. Timepoint: Before the intervention and after completion of the 12 treatment sessions. Method of measurement: Quadriceps muscle strength will be measured using a handheld dynamometer. Physical function and symptoms related to knee osteoarthritis. Timepoint: Before the intervention and after completion of the 12 treatment sessions. Method of measurement: Measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Tehran University of Medical Sciences Approved 2026-08-01 Ethics Committee of Tehran University of Medical Sciences Mirkhani Street (East Nosrat), Tohid Square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)