Blood Flow Restriction to Improve Muscle Strength After ACL Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Blood Flow Restriction Training to Improve Muscle Strength and Function Following Anterior Cruciate Ligament Injury

Conditions
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Anterior Cruciate Ligament Injury

Intervention / Treatment
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* Device: DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training
* Other: Eccentric Exercise with BLAST Leg Press System
* Other: Concentric Exercise with BLAST Leg Press System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 6) English-speaking Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eccentric Exercise with Delfi Blood Flow Restriction Training<br>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%. | Device: DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training<br>* cuff is inflated to 80% of an individuals limb occlusion pressure<br>* Other names: Kaatsu Training;Other: Eccentric Exercise with BLAST Leg Press System<br>* 4 sets of 10 repetitions of an eccentric leg press exercise performed at 70% of the 1 repetition maximum<br>|
| Experimental: Concentric Exercise with Delfi Blood Flow Restriction Training<br>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. | Device: DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training<br>* cuff is inflated to 80% of an individuals limb occlusion pressure<br>* Other names: Kaatsu Training;Other: Concentric Exercise with BLAST Leg Press System<br>* 4 sets of 10 repetitions of an concentric leg press exercise performed at 70% of the 1 repetition maximum<br>|
| Active Comparator: Eccentric Exercise<br>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. | Other: Eccentric Exercise with BLAST Leg Press System<br>* 4 sets of 10 repetitions of an eccentric leg press exercise performed at 70% of the 1 repetition maximum<br>|
| Active Comparator: Concentric Exercise<br>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%. | Other: Concentric Exercise with BLAST Leg Press System<br>* 4 sets of 10 repetitions of an concentric leg press exercise performed at 70% of the 1 repetition maximum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to return to activity in quadriceps muscle strength | concentric isokinetic muscle strength at 60 degrees per second | Pre-surgery (baseline), Return to Activity ( 9 months post-surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Flexion Angle | Peak knee flexion angle recorded during a single-legged hop (units: degrees) | Return to Activity ( 9 months post-surgery) | 
| Knee Flexion Moment | Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg) | Return to Activity ( 9 months post-surgery) | 
| Change from baseline to pre-intervention in PROMIS Global Health Scale | Patient-reported outcome measured to assess health related quality of life. Physical Function Average: t score = 50±10 Min: 10 Max: 90 | Pre-surgery (baseline), Pre-intervention ( 10 weeks post-surgery) | 
| Change from baseline to post-intervention in PROMIS Global Health Scale | Patient-reported outcome measured to assess health related quality of life. Physical Function Average: t score = 50±10 Min: 10 Max: 90 | Pre-surgery (baseline), Post-intervention ( 18 weeks post-surgery) | 
| Change from baseline to return to activity in PROMIS Global Health Scale | Patient-reported outcome measured to assess health related quality of life. Physical Function Average: t score = 50±10 Min: 10 Max: 90 | Pre-surgery (baseline),Return to Activity ( 9 months post-surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL, Knee, Muscle