Blood Flow Restriction to Improve Muscle Strength After ACL Injury

NCT ID: NCT03141801

Last Updated: 2019-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-25
• Study Completion Date: 2018-11-21

Brief Summary

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

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)

Conditions

Anterior Cruciate Ligament Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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%.

Group Type: EXPERIMENTAL

DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training

Intervention Type: DEVICE

cuff is inflated to 80% of an individuals limb occlusion pressure

Eccentric Exercise with BLAST Leg Press System

Intervention Type: OTHER

4 sets of 10 repetitions of an eccentric leg press exercise performed at 70% of the 1 repetition maximum

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.

Group Type: EXPERIMENTAL

DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training

Intervention Type: DEVICE

cuff is inflated to 80% of an individuals limb occlusion pressure

Concentric Exercise with BLAST Leg Press System

Intervention Type: OTHER

4 sets of 10 repetitions of an concentric leg press exercise performed at 70% of the 1 repetition maximum

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.

Group Type: ACTIVE_COMPARATOR

Eccentric Exercise with BLAST Leg Press System

Intervention Type: OTHER

4 sets of 10 repetitions of an eccentric leg press exercise performed at 70% of the 1 repetition maximum

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%.

Group Type: ACTIVE_COMPARATOR

Concentric Exercise with BLAST Leg Press System

Intervention Type: OTHER

4 sets of 10 repetitions of an concentric leg press exercise performed at 70% of the 1 repetition maximum

Interventions

DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training

cuff is inflated to 80% of an individuals limb occlusion pressure

Intervention Type: DEVICE

Eccentric Exercise with BLAST Leg Press System

4 sets of 10 repetitions of an eccentric leg press exercise performed at 70% of the 1 repetition maximum

Intervention Type: OTHER

Concentric Exercise with BLAST Leg Press System

4 sets of 10 repetitions of an concentric leg press exercise performed at 70% of the 1 repetition maximum

Intervention Type: OTHER

Other Intervention Names

Kaatsu Training

Eligibility Criteria

Inclusion Criteria

1. suffered an acute, complete ACL rupture as confirmed by MRI

2. scheduled to undergo ACL reconstruction

3. scheduled to undergo ACL reconstruction with a surgeon affiliated with MedSport (University of Michigan Orthopaedic Clinic)

4. 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

1. inability to provide written informed consent (or assent)

2. female subjects who are pregnant or are planning to become pregnant during the study timeframe

3. previous ACL injury

4. previous surgery to either knee

5. bony fracture accompanying ACL injury

6. chronic ACL injuries (for our study, this is defined as patient reporting to a physician greater than 2 weeks after initial injury)

7. patients who experienced a knee dislocation

8. History of blood clots

9. Previous deep vein thrombosis

10. Use of estrogen or progestin contraceptive

11. History of cerebrovascular disease

12. History of peripheral vascular disease

13. History of Sickle Cell Anemia

14. History of chronic muscular disorder (e.g. fibromyalgia)

15. History of severe hypertension

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Riann Palmieri-Smith

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

Curran MT, Bedi A, Mendias CL, Wojtys EM, Kujawa MV, Palmieri-Smith RM. Blood Flow Restriction Training Applied With High-Intensity Exercise Does Not Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Am J Sports Med. 2020 Mar;48(4):825-837. doi: 10.1177/0363546520904008.

Reference Type: DERIVED

PMID: 32167837 (View on PubMed)

Other Identifiers

HUM00110455

Identifier Type: -

Identifier Source: org_study_id