Background Blood flow restriction training (BFRT) uses a specialized tourniquet system to restrict arterial inflow and venous outflow to the limb during low-load resistance exercise. BFRT has the potential to augment strength gains for rehabilitation patients who are unable to tolerate high intensity resistance training. Objective To determine if BFRT will accelerate the recovery of thigh muscle function and strength in post-operative TKA compared to a standard post-operative rehabilitation protocol. Primary Outcome Measures: Quadriceps Strength: dynamometry (hand held) Secondary Outcomes Measures: Patient Reported Outcomes Knee Injury and Osteoarthritis Outcome Score, Jr Veterans Rand -12 Functional Measures Timed stair ascent Four square Test 5x Sit to Stand Test Study Design Open label randomized clinical trial with a 1:1 allocation in random sized blocks Sample Size Based on a Pre-TKA Quadriceps Maximal Voluntary Isometric Contraction mean of 18 with a standard deviation of 8, expecting a 20% improvement of MVIC with BFRT compared to standard Physical Therapy, with an α of 0.05 and β of 0.20 (80% power), the sample size is 63 in each arm. To account for a 20% drop-out rate, a total of 75 subjects will be enrolled in each arm Study Arms Control arm: Subjects will receive American College of Sports Medicine guided-strength training Experimental: Subjects will receive BFRT strength training as part of their post-operative physical therapy program for two months during normal post-op rehab.
Background Blood flow restriction training (BFRT) uses a specialized tourniquet system to restrict arterial inflow and venous outflow to the limb during low-load resistance exercise. BFRT has the potential to augment strength gains for rehabilitation patients who are unable to tolerate high intensity resistance training. Objective To determine if BFRT will accelerate the recovery of thigh muscle function and strength in post-operative TKA compared to a standard post-operative rehabilitation protocol. Primary Outcome Measures: Quadriceps Strength: dynamometry (hand held) Secondary Outcomes Measures: Patient Reported Outcomes Knee Injury and Osteoarthritis Outcome Score, Jr Veterans Rand -12 Functional Measures Timed stair ascent Four square Test 5x Sit to Stand Test Study Design Open label randomized clinical trial with a 1:1 allocation in random sized blocks Sample Size Based on a Pre-TKA Quadriceps Maximal Voluntary Isometric Contraction mean of 18 with a standard deviation of 8, expecting a 20% improvement of MVIC with BFRT compared to standard Physical Therapy, with an α of 0.05 and β of 0.20 (80% power), the sample size is 63 in each arm. To account for a 20% drop-out rate, a total of 75 subjects will be enrolled in each arm Study Arms Control arm: Subjects will receive American College of Sports Medicine guided-strength training Experimental: Subjects will receive BFRT strength training as part of their post-operative physical therapy program for two months during normal post-op rehab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Same as Standard PT with the exception that BFRT involves placing the pressure cuff before the start of therapeutic exercises
Therapeutic exercise, including but not limited to: movement re-education, balance, and functional strength training; and Manual Physical Therapy including but not limited to passive range of motion (therapist will move your knee without your help), joint mobilization, soft-tissue mobilization and static stretching
Norton Healthcare
Louisville, Kentucky, United States
Quadriceps Strength
Quadriceps Strength measured using a handheld dynamoneter
Time frame: 12 weeks post-op
Knee Injury and Osteoarthritis Outcome Score, Jr,
Knee Injury and Osteoarthritis Outcome Score, Jr,
Time frame: Pre-Op, 6 and 12 weeks and 12 months post-op
Veterans Rand -12
Veterans Rand -12
Time frame: Pre-Op, 6 and 12 weeks and 12 months post-op
Four square Test
Subject will be asked to walk forward, sideways, backward and sideways over four squares.
Time frame: Pre-Op, 6 and 12 weeks post-op
5x Sit to Stand Test
Subject will be asked to sit in a chair with back straight and feet on a flat surface positioned about shoulder width apart, arms crossed at chest and asked to stand up and sit down five times.
Time frame: Pre-Op, 6 and 12 weeks and 12 months post-op
Quadriceps Strength
Quadriceps Strength measured using a handheld dynamoneter
Time frame: 6 weeks post-op
Quadriceps Strength
Quadriceps Strength measured using a handheld dynamoneter
Time frame: 12 months post-op
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