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Blood Flow Restriction to Improve Muscle Strength After ACL Injury

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ClinicalTrials.gov Identifier: NCT03141801
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Riann Palmieri-Smith, University of Michigan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injury 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 Not Applicable

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)

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Blood Flow Restriction Training to Improve Muscle Strength and Function Following Anterior Cruciate Ligament Injury
Actual Study Start Date : August 25, 2016
Actual Primary Completion Date : November 21, 2018
Actual Study Completion Date : November 21, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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%.
 Device: DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training
cuff is inflated to 80% of an individuals limb occlusion pressure
Other Name: Kaatsu Training

Other: 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
Experimental: 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.
 Device: DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training
cuff is inflated to 80% of an individuals limb occlusion pressure
Other Name: Kaatsu Training

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
Active Comparator: 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.
 Other: 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
Active Comparator: 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%.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline to return to activity in quadriceps muscle strength [ Time Frame: Pre-surgery (baseline), Return to Activity (~9 months post-surgery) ]
    concentric isokinetic muscle strength at 60 degrees per second


Secondary Outcome Measures :
  1. Knee Flexion Angle [ Time Frame: Return to Activity (~9 months post-surgery) ]
    Peak knee flexion angle recorded during a single-legged hop (units: degrees)

  2. Knee Flexion Moment [ Time Frame: Return to Activity (~9 months post-surgery) ]
    Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg)

  3. Change from baseline to pre-intervention in PROMIS Global Health Scale [ Time Frame: Pre-surgery (baseline), Pre-intervention (~10 weeks post-surgery) ]
    Patient-reported outcome measured to assess health related quality of life. Physical Function Average: t score = 50±10 Min: 10 Max: 90

  4. Change from baseline to post-intervention in PROMIS Global Health Scale [ Time Frame: Pre-surgery (baseline), Post-intervention (~18 weeks post-surgery) ]
    Patient-reported outcome measured to assess health related quality of life. Physical Function Average: t score = 50±10 Min: 10 Max: 90

  5. Change from baseline to return to activity in PROMIS Global Health Scale [ Time Frame: Pre-surgery (baseline),Return to Activity (~9 months post-surgery) ]
    Patient-reported outcome measured to assess health related quality of life. Physical Function Average: t score = 50±10 Min: 10 Max: 90


Other Outcome Measures:
  1. Change from baseline to pre-intervention in quadriceps cross-sectional area [ Time Frame: Pre-surgery (baseline), Pre-intervention (~10 weeks post-surgery) ]
    cross-sectional area of the quadriceps muscle

  2. Change from baseline to post-intervention in quadriceps cross-sectional area [ Time Frame: Pre-surgery (baseline), Post-intervention (~18 weeks post-surgery) ]
    cross-sectional area of the quadriceps muscle

  3. Change from baseline to return to activity in quadriceps cross-sectional area [ Time Frame: Pre-surgery (baseline), Return to Activity (~9 months post-surgery) ]
    cross-sectional area of the quadriceps muscle


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141801


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Riann Palmieri-Smith, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03141801    
Other Study ID Numbers: HUM00110455
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riann Palmieri-Smith, University of Michigan:
ACL
Knee
Muscle
Additional relevant MeSH terms:
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Wounds and Injuries
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries