BFRT vs Standard PT After Total Knee Arthroplasty
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Total Knee Arthroplasty
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 70 years
- Gender
- Both males and females
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 intensit...
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 ? of 0.05 and ? 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.
Tracking Information
- NCT #
- NCT04366336
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jeffrey Stimac, MD Norton Healthcare