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IRCT20190717044238N13 IRCT 2024-05-12 Riphah International University Lahore Effects of resistance training in patients after total knee replacement surgery Effects of High-Intensity Versus Low-Intensity Resistance Training Along With Blood Flow Restriction in Patients with Total Knee Arthroplasty 2024-05-06 anticipated 34 Complete https://irct.ir/trial/76055 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization will be done by using computer generated randomizer. Allocation will be concealed by sealed envelope method, Blinding description: This study will be a single blinded study. Assessor will be kept blind about the group allocation and previous readings. N/A Total knee arthroplasty. Intervention 1: Intervention group:1BFR with Low Intensity Resistance training ( For the first two weeks participants will follow home plan of standard physical therapy. Resistance training will be started if patient weight bears on unilateral leg for 5 s without support, have knee ROM of 0-90° able to perform repeated straight leg raise without knee extensor muscle lag. Patients 10 Repetition maximum (RM) will be used to predict 1 RM value according to formula 10 RM/ 0.75. BFR will be achieved using a tourniquet, and limb occlusion pressure (LOP) will be calculated, defined as the minimum pressure required for full arterial occlusion. Its will be calculated as baseline Systolic blood pressure (SBP) and formula for safety margins will be applied: add 40-50 mm Hg for SBP<130, Add 60-75 mm Hg for SBP 131-190, Add 80 mm Hg for SBP > 190. 60% of the calculated pressure will be used. Prior to exercise the cuff will be placed on the most proximal portion of the limb. -Standard Physical Therapy:1) Ankle Pumps2) AAROM/ AROM3) Quadriceps, Hamstrings and adductor setting Exercises 4) Patellar Mobilization (grade I, II) 5) Hamstrings, Calf & IT Band Stretching -Resistance Training:5 min light cycling• Start with 10 repetitions of unliteral leg press at light weights• Calf raises • Knee flexion• Knee extension. Progress to 20-30% of predicted 1RM. Intervention 2: Intervention group: 2 BFR with High Intensity Resistance training (Resistance training will be started if patient weight bears on unilateral leg for 5 s without support, have knee ROM of 0-90° able to perform repeated straight leg raise without knee extensor muscle lag. Patients 10 Repetition maximum (RM) will be used to predict 1 RM value according to formula 10 RM/ 0.75. BFR will be achieved using a tourniquet, and limb occlusion pressure (LOP) will be calculated, defined as the minimum pressure required for full arterial occlusion. Its will be calculated as baseline Systolic blood pressure (SBP) and formula for safety margins will be applied: add 40-50 mm Hg for SBP<130, Add 60-75 mm Hg for SBP 131-190, Add 80 mm Hg for SBP > 190. 60% of the calculated pressure will be used. Prior to exercise the cuff will be placed on the most proximal portion of the limb. -Standard Physical Therapy:1) Ankle Pumps2) AAROM/ AROM3) Quadriceps, Hamstrings and adductor setting Exercises4) Patellar Mobilization (grade I, II)5) Hamstrings, Calf & IT Band Stretching -Resistance Training:5 min light cycling• Start with 10 repetitions of unliteral leg press at light weights• Calf raises • Knee flexion• Knee extension. Progress to 65-70% of predicted 1RM. No - There is not a plan to make this available Justification or reason for not sharing IPD is confidentiality of participants
public Maira Shahzad
Riphah International University Gulberg campus lahore
Lahore Pakistan 54000 +92 312 6635635 maairashahzad@gmail.com Riphah International University Lahore scientific Fareeha Amjad
Riphah International University Gulberg campus lahore
Lahore Pakistan 54000 +92 334 3372779 fari_fairy22@yahoo.com Riphah International University Lahore Pakistan Both male and female patients 50 to 65 years of age (27) Post-total knee arthroplasty for osteoarthritis Unilateral joint replacement surgery 50 years 65 years Both Impaired cognitive function and mental disease (e.g., diagnosis of Alzheimer's disease) Paraplegia/extremity amputation End-stage renal disease requiring dialysis Uncontrolled cardiovascular disease or Severe pulmonary disease Active neoplasm Body mass index greater than 40 kg/m² Peripheral vascular disease or deep vein thrombosis Opioid use and Chronic oral steroid use and anticoagulation use Ipsilateral joint disease involving hip, ankle, or spine Neurologic or other etiology of quadriceps wasting Z96.65 Presence of artificial knee joint Rehabilitation Rehabilitation Intervention group:1BFR with Low Intensity Resistance training ( For the first two weeks participants will follow home plan of standard physical therapy. Resistance training will be started if patient weight bears on unilateral leg for 5 s without support, have knee ROM of 0-90° able to perform repeated straight leg raise without knee extensor muscle lag. Patients 10 Repetition maximum (RM) will be used to predict 1 RM value according to formula 10 RM/ 0.75. BFR will be achieved using a tourniquet, and limb occlusion pressure (LOP) will be calculated, defined as the minimum pressure required for full arterial occlusion. Its will be calculated as baseline Systolic blood pressure (SBP) and formula for safety margins will be applied: add 40-50 mm Hg for SBP<130, Add 60-75 mm Hg for SBP 131-190, Add 80 mm Hg for SBP > 190. 60% of the calculated pressure will be used. Prior to exercise the cuff will be placed on the most proximal portion of the limb. -Standard Physical Therapy:1) Ankle Pumps2) AAROM/ AROM3) Quadriceps, Hamstrings and adductor setting Exercises 4) Patellar Mobilization (grade I, II) 5) Hamstrings, Calf & IT Band Stretching -Resistance Training:5 min light cycling• Start with 10 repetitions of unliteral leg press at light weights• Calf raises • Knee flexion• Knee extension. Progress to 20-30% of predicted 1RM Intervention group: 2 BFR with High Intensity Resistance training (Resistance training will be started if patient weight bears on unilateral leg for 5 s without support, have knee ROM of 0-90° able to perform repeated straight leg raise without knee extensor muscle lag. Patients 10 Repetition maximum (RM) will be used to predict 1 RM value according to formula 10 RM/ 0.75. BFR will be achieved using a tourniquet, and limb occlusion pressure (LOP) will be calculated, defined as the minimum pressure required for full arterial occlusion. Its will be calculated as baseline Systolic blood pressure (SBP) and formula for safety margins will be applied: add 40-50 mm Hg for SBP<130, Add 60-75 mm Hg for SBP 131-190, Add 80 mm Hg for SBP > 190. 60% of the calculated pressure will be used. Prior to exercise the cuff will be placed on the most proximal portion of the limb. -Standard Physical Therapy:1) Ankle Pumps2) AAROM/ AROM3) Quadriceps, Hamstrings and adductor setting Exercises4) Patellar Mobilization (grade I, II)5) Hamstrings, Calf & IT Band Stretching -Resistance Training:5 min light cycling• Start with 10 repetitions of unliteral leg press at light weights• Calf raises • Knee flexion• Knee extension. Progress to 65-70% of predicted 1RM Pain. Timepoint: baseline , at 4th week and post training at 8th week. Method of measurement: Numeric Pain Rating Scale (NPRS). Knee range of motion ROM. Timepoint: baseline , at 4th week and post training at 8th week. Method of measurement: Universal Goniometer. Strength. Timepoint: baseline , at 4th week and post training at 8th week. Method of measurement: Hand-Held Dynamometer. Quadriceps muscle thickness. Timepoint: baseline & at the end of 8th week. Method of measurement: Ultrasound Imaging. Functional Performance. Timepoint: baseline , at 4th week and post training at 8th week. Method of measurement: a) Lower Extremity Function Scale b) 6-Minute Walk Test. Riphah International University Lahore Approved 2024-04-03 Research and ethics Commitee Riphah College of Rehabilitation and Allied Health Sciences Riphah International University Gulberg campus lahore Lahore Punjab Pakistan