Blood Flow Restriction Training to Improve Muscle Strength and Function Following Anterior Cruciate Ligament Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change from baseline to return to activity in quadriceps muscle strength
研究概览
简要总结
Quadriceps muscle weakness is a common consequence following anterior cruciate ligament (ACL) injury and reconstruction. Maximizing quadriceps strength following ACL injury is significant as diminished quadriceps strength has been linked to the osteoarthritis that affects over 50% of surgically reconstructed limbs. Given that knee joint health following ACL injury is predicated on restoring quadriceps strength, identifying treatment approaches capable of improving strength is paramount. Blood flow restriction training (BFRT) is a method where oxygen to the muscle is intentionally reduced during exercise/rehabilitation and may lead to more timely and substantial strength gains. In the proposed project, we will examine the efficacy of BFRT in patients who have undergone ACL reconstruction and suffer from substantial quadriceps weakness.
详细描述
Quadriceps muscle weakness is a common consequence following anterior cruciate ligament (ACL) injury and reconstruction. Maximizing quadriceps strength following ACL injury is significant as diminished quadriceps strength has been linked to the osteoarthritis that affects over 50% of surgically reconstructed limbs. Given that knee joint health following ACL injury is predicated on restoring quadriceps strength, identifying treatment approaches capable of improving strength is paramount. Blood flow restriction training (BFRT) is a method whereby oxygen to the muscle is intentionally reduced during exercise/rehabilitation and may lead to more timely and substantial strength gains. In the proposed project, we will examine the efficacy of BFRT in patients who have undergone ACL reconstruction and suffer from quadriceps weakness. This project will have a randomized clinical trial design. Sixty patients that have torn their ACL and plan to undergo surgical reconstruction will be randomized into one of four groups: 1) eccentric exercise; 2) concentric exercise; 3) eccentric exercise with blood flow restriction; or 4) concentric exercise with blood flow restriction. All patients regardless of randomization assignment will also receive standard of care ACL rehabilitation. Approximately 6 weeks after ACL reconstruction surgery, patients will begin to receive the study interventions which will last for 8 weeks. The concentric exercise will be a leg press exercise done on a conventional leg press machine, while the eccentric exercise will be a leg press exercise done on a device designed to elicit eccentric muscle contractions. Patients will train at 70% of their 1 repetition maximum and will complete 4 sets of 10 contractions at each session (2 sessions/week). For patients randomized to the BFRT groups they will complete the leg press exercise while blood flow the the quadriceps muscle is restricted with a BFRT device (Delfi Personalized Tourniquet System for Blood Flow Restriction). We will quantify our dependent variables prior to surgical reconstruction, 6 weeks post-operatively (before study intervention starts), 14 weeks post-operatively (immediately after study intervention ends), and time of physician discharge from rehabilitation (e.g. time medical clearance for return to activity). The primary outcome is isokinetic quadriceps strength. We hypothesize that patients who complete eccentric exercise along with blood flow restriction training will realize the greatest gains in muscle strength.
The DELFI PTS Personalized Tourniquet system is exempt from premarket notification and is therefore not subject to 510(k)
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
- 14 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suffered an acute, complete ACL rupture as confirmed by MRI
- •scheduled to undergo ACL reconstruction
- •scheduled to undergo ACL reconstruction with a surgeon affiliated with MedSport (University of Michigan Orthopaedic Clinic)
- •willing to undergo rehabilitation through MedSport (University of Michigan Orthopaedic Clinic) 5)) Willingness to participate in testing and follow-up as outlined in the protocol
- •English-speaking
排除标准
- •inability to provide written informed consent (or assent)
- •female subjects who are pregnant or are planning to become pregnant during the study timeframe
- •previous ACL injury
- •previous surgery to either knee
- •bony fracture accompanying ACL injury
- •chronic ACL injuries (for our study, this is defined as patient reporting to a physician greater than 2 weeks after initial injury)
- •patients who experienced a knee dislocation
- •History of blood clots
- •Previous deep vein thrombosis
- •Use of estrogen or progestin contraceptive
- •History of cerebrovascular disease
- •History of peripheral vascular disease
- •History of Sickle Cell Anemia
- •History of chronic muscular disorder (e.g. fibromyalgia)
- •History of severe hypertension
研究组 & 干预措施
Eccentric Exercise with Delfi Blood Flow Restriction Training
Patients randomized to the eccentric exercise + blood flow restriction training group will receive eccentric exercise two times per week for 8 weeks, beginning 8-12 weeks after anterior cruciate ligament reconstruction. Patients will completed the exercise with knee range of motion limited to 20-60 degrees of knee flexion and will train at an intensity equal to 70% of their eccentric 1-repetition maximum for 4 sets of 10 repetitions. During exercise, patients will have the DELFI personalized tourniquet system applied over the quadriceps to restrict blood flow. The tourniquet will be set to a limb occlusion pressure of 80%.
干预措施: DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training (Device)
Eccentric Exercise with Delfi Blood Flow Restriction Training
Patients randomized to the eccentric exercise + blood flow restriction training group will receive eccentric exercise two times per week for 8 weeks, beginning 8-12 weeks after anterior cruciate ligament reconstruction. Patients will completed the exercise with knee range of motion limited to 20-60 degrees of knee flexion and will train at an intensity equal to 70% of their eccentric 1-repetition maximum for 4 sets of 10 repetitions. During exercise, patients will have the DELFI personalized tourniquet system applied over the quadriceps to restrict blood flow. The tourniquet will be set to a limb occlusion pressure of 80%.
干预措施: Eccentric Exercise with BLAST Leg Press System (Other)
Concentric Exercise with Delfi Blood Flow Restriction Training
Patients randomized to the concentric exercise group will receive concentric exercise two times per week for 8 weeks, beginning 8-12 weeks after anterior cruciate ligament reconstruction. Patients will completed the exercise with knee range of motion limited to 20-60 degrees of knee flexion and will train at an intensity equal to 70% of their concentric 1-repetition maximum for 4 sets of 10 repetitions.
干预措施: DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training (Device)
Concentric Exercise with Delfi Blood Flow Restriction Training
Patients randomized to the concentric exercise group will receive concentric exercise two times per week for 8 weeks, beginning 8-12 weeks after anterior cruciate ligament reconstruction. Patients will completed the exercise with knee range of motion limited to 20-60 degrees of knee flexion and will train at an intensity equal to 70% of their concentric 1-repetition maximum for 4 sets of 10 repetitions.
干预措施: Concentric Exercise with BLAST Leg Press System (Other)
Eccentric Exercise
Patients randomized to the eccentric exercise group will receive eccentric exercise two times per week for 8 weeks, beginning 8-12 weeks after anterior cruciate ligament reconstruction. Patients will completed the exercise with knee range of motion limited to 20-60 degrees of knee flexion and will train at an intensity equal to 70% of their eccentric 1-repetition maximum for 4 sets of 10 repetitions.
干预措施: Eccentric Exercise with BLAST Leg Press System (Other)
Concentric Exercise
Patients randomized to the concentric exercise group will receive concentric exercise two times per week for 8 weeks, beginning 8-12 weeks after anterior cruciate ligament reconstruction. Patients will completed the exercise with knee range of motion limited to 20-60 degrees of knee flexion and will train at an intensity equal to 70% of their concentric 1-repetition maximum for 4 sets of 10 repetitions. During exercise, patients will have the DELFI personalized tourniquet system applied over the quadriceps to restrict blood flow. The tourniquet will be set to a limb occlusion pressure of 80%.
干预措施: Concentric Exercise with BLAST Leg Press System (Other)
结局指标
主要结局
Change from baseline to return to activity in quadriceps muscle strength
时间窗: Pre-surgery (baseline), Return to Activity (~9 months post-surgery)
concentric isokinetic muscle strength at 60 degrees per second
次要结局
- Knee Flexion Angle(Return to Activity (~9 months post-surgery))
- Knee Flexion Moment(Return to Activity (~9 months post-surgery))
- Change from baseline to pre-intervention in PROMIS Global Health Scale(Pre-surgery (baseline), Pre-intervention (~10 weeks post-surgery))
- Change from baseline to post-intervention in PROMIS Global Health Scale(Pre-surgery (baseline), Post-intervention (~18 weeks post-surgery))
- Change from baseline to return to activity in PROMIS Global Health Scale(Pre-surgery (baseline),Return to Activity (~9 months post-surgery))
研究者
Riann Palmieri-Smith
Associate Professor
University of Michigan