Use of Blood Flow Restriction + Progressive Resistance Functional Training to Improve Functional Outcomes After Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Maximal Voluntary Contraction
研究概览
简要总结
This will be a randomized pilot study to determine the effectiveness of Personalized Blood Flow Restriction (PBFR) technique in conjunction with prescribed physical therapy (PT) in a cohort of anterior cruciate ligament (ACL) reconstruction subjects
详细描述
This will be a randomized pilot study to determine the effectiveness of Personalized Blood Flow Restriction (PBFR) technique in conjunction with prescribed physical therapy (PT) in a cohort of anterior cruciate ligament (ACL) reconstruction subjects. Both groups of subjects will undergo unilateral ACL reconstruction at University of Arkansas for Medical Sciences (UAMS), followed by prescribed PT at the UAMS Orthopedic Clinic at Colonel Glenn.
Up to 25 subjects will be enrolled. Half are randomized to the BFR group with the other will perform PT without BFR.
Data collection will occur at four approximate occasions: pre-surgery, 8-weeks postop, 12-weeks postop, and 16-weeks postop.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, ages 18-34 years.
- •Scheduled to undergo elective ACL surgery at UAMS.
- •Capable of providing informed consent.
- •Willing to exercise with BFR.
- •COVID-19 negative or asymptomatic.
排除标准
- •Any surgical indication other than ACL repair.
- •Body mass index >
- •Pregnant female.
- •Neurological, musculoskeletal, or other disorder that would preclude them from completing the exercise training intervention and all performance tests.
- •Hypertension as evidenced by systolic BP >150 at rest OR diastolic BP >85 at rest.
- •Heart failure as evidenced by use of prescription diuretics.
- •History of atrial fibrillation.
- •Oxygen saturation <95% on room air at rest.
- •Any other medical condition that would interfere with testing or increase one's risk of complications during exercise.
- •Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
- •Compromised vascular circulation in the legs (e.g. peripheral vascular disease).
- •History of deep vein thrombosis.
- •Varicose veins in the legs.
- •Known Sickle cell disease or trait.
- •Unwilling to avoid using protein or amino-acid supplements during participation.
- •Unwilling to avoid using BFR during prescribed post-operative physical therapy.
研究组 & 干预措施
physical therapy with blood flow restriction
干预措施: blood flow restriction (Other)
physical therapy without blood flow restriction
Standard of care.
干预措施: physical therapy standard of care (Other)
结局指标
主要结局
Maximal Voluntary Contraction
时间窗: 16-weeks post-surgery
Max torque produced in newton meter per second during an isometric contraction
ACL Repair Range of Motion
时间窗: from enrollment to the end of treatment at 16 weeks
Measured at the knee, therefore, the degree to which the lower limb can move around knee joint in relation to the upper limb.
次要结局
未报告次要终点