Anterior Cruciate Ligament InjuryNCT03141801
Blood Flow Restriction to Improve Muscle Strength After ACL Injury
A study testing DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training, Eccentric Exercise with BLAST Leg Press System and Concentric Exercise with BLAST Leg Press System in people with Anterior Cruciate Ligament Injury, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 30 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training, Eccentric Exercise with BLAST Leg Press System and Concentric Exercise with BLAST Leg Press System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2016to 21 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Flow Restriction Training to Improve Muscle Strength and Function Following Anterior Cruciate Ligament Injury
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.
Read the 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
- Being tested
- DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training, Eccentric Exercise with BLAST Leg Press System, Concentric Exercise with BLAST Leg Press System
- Keywords
- ACL, Knee, Muscle
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DELFI PTS Personalized Tourniquet System for Blood Flow Restriction TrainingDevice
Also called Kaatsu Training
cuff is inflated to 80% of an individuals limb occlusion pressure
Eccentric Exercise with BLAST Leg Press SystemOther
4 sets of 10 repetitions of an eccentric leg press exercise performed at 70% of the 1 repetition maximum
Concentric Exercise with BLAST Leg Press SystemOther
4 sets of 10 repetitions of an concentric leg press exercise performed at 70% of the 1 repetition maximum
| Study group | Role | What they receive |
|---|---|---|
| Eccentric Exercise with Delfi Blood Flow Restriction Training | Experimental | 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%. Receives: Device: DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training; Other: Eccentric Exercise with BLAST Leg Press System |
| Concentric Exercise with Delfi Blood Flow Restriction Training | Experimental | 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. Receives: Device: DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training; Other: Concentric Exercise with BLAST Leg Press System |
| Eccentric Exercise | Active comparator | 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. Receives: Other: Eccentric Exercise with BLAST Leg Press System |
| Concentric Exercise | Active comparator | 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%. Receives: Other: Concentric Exercise with BLAST Leg Press System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to return to activity in quadriceps muscle strength
concentric isokinetic muscle strength at 60 degrees per second
Measured: Pre-surgery (baseline), Return to Activity (~9 months post-surgery)
Secondary outcomes (5)
Knee Flexion Angle
Peak knee flexion angle recorded during a single-legged hop (units: degrees)
Measured: Return to Activity (~9 months post-surgery)
Knee Flexion Moment
Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg)
Measured: 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
Measured: 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
Measured: 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
Measured: Pre-surgery (baseline),Return to Activity (~9 months post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start25 Aug 2016
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riann Palmieri-Smith, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141801
- Sponsor's protocol ID
- HUM00110455
- Status last verified
- Jan 2019
- First submitted
- 17 Apr 2017
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32167837
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Training to Improve Muscle Strength and Function Following Anterior Cruciate Ligament Injury
- ClinicalTrials.gov ID
- NCT03141801
- Acronym / sponsor ID
- HUM00110455
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- ACL, Knee, Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 25 Aug 2016 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eccentric Exercise with Delfi Blood Flow Restriction Training | Experimental | Device: DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training, Other: Eccentric Exercise with BLAST Leg Press SystemPatients 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%. |
| Concentric Exercise with Delfi Blood Flow Restriction Training | Experimental | Device: DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training, Other: Concentric Exercise with BLAST Leg Press SystemPatients 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. |
| Eccentric Exercise | Active comparator | Other: Eccentric Exercise with BLAST Leg Press SystemPatients 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. |
| Concentric Exercise | Active comparator | Other: Concentric Exercise with BLAST Leg Press SystemPatients 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%. |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DELFI PTS Personalized Tourniquet System for Blood Flow Restriction TrainingAlso: Kaatsu Trainingcuff is inflated to 80% of an individuals limb occlusion pressure | Device | Concentric Exercise with Delfi Blood Flow Restriction Training, Eccentric Exercise with Delfi Blood Flow Restriction Training |
| Eccentric Exercise with BLAST Leg Press System4 sets of 10 repetitions of an eccentric leg press exercise performed at 70% of the 1 repetition maximum | Other | Eccentric Exercise, Eccentric Exercise with Delfi Blood Flow Restriction Training |
| Concentric Exercise with BLAST Leg Press System4 sets of 10 repetitions of an concentric leg press exercise performed at 70% of the 1 repetition maximum | Other | Concentric Exercise, Concentric Exercise with Delfi Blood Flow Restriction Training |
Primary outcome
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
5 secondary outcomes
Knee Flexion Angle
Time frame: Return to Activity (~9 months post-surgery)
Knee Flexion Moment
Time frame: Return to Activity (~9 months post-surgery)
Change from baseline to pre-intervention in PROMIS Global Health Scale
Time frame: Pre-surgery (baseline), Pre-intervention (~10 weeks post-surgery)
Change from baseline to post-intervention in PROMIS Global Health Scale
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Derived from this study: PubMed 32167837Curran 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training, Eccentric Exercise with BLAST Leg Press System and Concentric Exercise with BLAST Leg Press System in people with Anterior Cruciate Ligament Injury, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to return to activity in quadriceps muscle strength (time frame: Pre-surgery (baseline), Return to Activity (~9 months post-surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03141801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.