Blood Flow Restriction Training Versus Traditional Rehab in Patients With Lower Extremity Fractures: Effect on Fracture Healing, Muscle Strength and Girth, and Return to Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Fracture healing
研究概览
简要总结
This study will look at the effect of using a blood flow restriction device during low load strengthening exercises on patients with tibial shaft fractures, compared to patients performing exercise without the device. The study will compare muscle strength, muscle size, fracture healing, and return to normal function between the two groups.
详细描述
This study will examine the effect of blood flow restriction (BFR) training in patients with lower extremity fractures. Patients with tibial shaft fractures will be assigned to either the BFR group or control group. The BFR group will perform exercises with a blood flow restriction device, which occludes venous blood flow in the limb, while performing strengthening exercises as directed by a Doctor of Physical Therapy. The control group will perform the exercises without the device, as is current standard practice in physical therapy. Blood flow restriction training has been shown to prevent strength loss and muscle atrophy after surgery or injury, and studies suggest that it increases biomarkers of bone metabolism and tissue healing. The goal of this study is to examine the use of BFR in trauma patients using a defined protocol, and compare fracture healing, muscle strength, muscle girth, and subjective physical function between groups.
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
盲法说明
Masking is not possible due to evident use or nonuse of device, and documentation in patient's chart.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult with closed tibial shaft fracture
- •Ability to begin physical therapy treatment within 2 weeks post-operatively
排除标准
- •History of osteoporosis or osteopenia
- •Impaired circulation in the limb
- •Active deep vein thrombosis
- •Clotting disorders or other elevated risk of embolism
- •Sickle cell anemia
- •Infection in extremity
- •Renal compromise
- •Severe uncontrolled hypertension (SBP>180)
- •Lymphedema
- •Under age 18
- •Pregnancy
结局指标
主要结局
Fracture healing
时间窗: 6 weeks, 12 weeks, 6 months
Tibial shaft fracture healing as measured by Radiographic Union Score for Tibial (RUST) fractures
次要结局
- Muscle strength(2 weeks, 4 weeks, 6 weeks, 12 weeks, and 6 months)
- Muscle girth(2, 4, 6, 12 weeks and 6 months)
- Physical function(2, 6,12 weeks and 6 months)