- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03141801
Blood Flow Restriction to Improve Muscle Strength After ACL Injury
Blood Flow Restriction Training to Improve Muscle Strength and Function Following Anterior Cruciate Ligament Injury
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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%.
|
cuff is inflated to 80% of an individuals limb occlusion pressure
Other Names:
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.
|
cuff is inflated to 80% of an individuals limb occlusion pressure
Other Names:
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.
|
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%.
|
4 sets of 10 repetitions of an concentric leg press exercise performed at 70% of the 1 repetition maximum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline to return to activity in quadriceps muscle strength
Time Frame: Pre-surgery (baseline), Return to Activity (~9 months post-surgery)
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concentric isokinetic muscle strength at 60 degrees per second
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Pre-surgery (baseline), Return to Activity (~9 months post-surgery)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee Flexion Angle
Time Frame: Return to Activity (~9 months post-surgery)
|
Peak knee flexion angle recorded during a single-legged hop (units: degrees)
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Return to Activity (~9 months post-surgery)
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Knee Flexion Moment
Time Frame: Return to Activity (~9 months post-surgery)
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Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg)
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Return to Activity (~9 months post-surgery)
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Change from baseline to pre-intervention in PROMIS Global Health Scale
Time Frame: Pre-surgery (baseline), Pre-intervention (~10 weeks post-surgery)
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Patient-reported outcome measured to assess health related quality of life.
Physical Function Average: t score = 50±10 Min: 10 Max: 90
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Pre-surgery (baseline), Pre-intervention (~10 weeks post-surgery)
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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
|
Pre-surgery (baseline), Post-intervention (~18 weeks post-surgery)
|
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
|
Pre-surgery (baseline),Return to Activity (~9 months post-surgery)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline to pre-intervention in quadriceps cross-sectional area
Time Frame: Pre-surgery (baseline), Pre-intervention (~10 weeks post-surgery)
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cross-sectional area of the quadriceps muscle
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Pre-surgery (baseline), Pre-intervention (~10 weeks post-surgery)
|
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
|
Pre-surgery (baseline), Post-intervention (~18 weeks post-surgery)
|
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
|
Pre-surgery (baseline), Return to Activity (~9 months post-surgery)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00110455
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anterior Cruciate Ligament Injury
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Lynn Snyder-MacklerCompletedAcute Injury of Anterior Cruciate LigamentUnited States
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Universidad de GranadaCompletedAcute Injury of Anterior Cruciate LigamentSpain
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