Status
Conditions
Treatments
About
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.
Full description
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.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Status post primary TKA and cleared by surgeon for Physical Therapy.
Ages 50-79 years old
Able to participate fully in PT
Primary cruciate retaining or posterior stabilized TKA.
Knee Range of Motion of surgical extremity is a minimum of 5° on full extension to 90° on full flexion
• Exclusion Criteria:
Unable to consent for study participation
Unable to participate in preoperative testing
Any ligamentous or osseous reconstruction at time of surgery that limits weight bearing
History of Deep Vein Thrombosis
Injury or recent procedure to uninvolved extremity within 6 months
History of endothelial dysfunction
History of Peripheral Vascular Disease including varicose veins
Easy bruisability
TKA is revision
History of surgical wound complication on involved extremity
History of stroke
History of dementia
History of neuromuscular disorder
History of Chronic Obstructive Pulmonary Disease
History of diabetes mellitus with neuropathy
History of previous intra-articular fracture of involved extremity causing surgical fixation
History of sickle cell trait/disease
Previous participation in BFRT
Any surgical procedure affecting their ability to complete all PT sessions or testing.
History of functionally limiting arthritis in non-surgical Lower Extremity
Prior contralateral Total Knee Arthroplasty
Prior Total Hip Arthroplasty
Positive pregnancy test
Enrollment into another clinical research trial
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal