Blood Flow Restriction Training Vs Standard Physical Therapy Following Total Knee Arthroplasty Prospective Intervention Study (Blood Flow Restriction Training: BFRT)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Quadriceps Strength
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Quadriceps Strength
时间窗: 12 weeks post-op
Quadriceps Strength measured using a handheld dynamoneter
次要结局
- Knee Injury and Osteoarthritis Outcome Score, Jr,(Pre-Op, 6 and 12 weeks and 12 months post-op)
- 5x Sit to Stand Test(Pre-Op, 6 and 12 weeks and 12 months post-op)
- Four square Test(Pre-Op, 6 and 12 weeks post-op)
- Veterans Rand -12(Pre-Op, 6 and 12 weeks and 12 months post-op)
- Quadriceps Strength(12 months post-op)