Anterior Cruciate Ligament InjuriesNCT04086030
Blood Flow Restriction Following ACLR
A study testing Blood Flow Restriction Training in people with Anterior Cruciate Ligament Injuries and ACL, run by Rush University Medical Center.
Trial summary
The purpose of this study is to evaluate the the ability of BFR to reduce muscle loss and improve strength after ACL reconstruction. It is hypothesized that BFR training will significantly reduce muscle loss and improve strength after ACL reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, ACL, Physical Therapy
- What is being tested?
- Blood Flow Restriction Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Dec 2024
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients 18-40
- English-speaking
- Primary ACL Reconstruction
- No associated procedures (meniscal repair, other ligamentous pathology), or history of deep vein thrombosis.
- Clinical and radiographic examination (MRI) consistent with an acute full thickness ACL tear and surgical consent for ACL reconstruction with a patellar tendon autograft
- Written and informed consent for study participation
Who cannot join
- Patients younger than 18 or older than 40 years of age
- Non-native English speaker
- Revision surgery or prior history of knee surgery
- Concomitant ligamentous, meniscal, or cartilage injury that would alter postoperative weight bearing status or rehabilitation protocol
- Inability to comply with the proposed follow-up clinic visits
- Patients lacking decisional capacity
Show all 11Show fewer
- Patients with a history of deep vein thrombosis, pulmonary embolism, or known clotting disorder or hypercoagulable state
- Pregnant or breast-feeding women. Pregnancy as determined by a positive pregnancy test prior to procedure. Females of childbearing potential must agree to use an acceptable birth control method during study participation.
- Worker's compensation patients
- Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study
- Any psychiatric illness that would prevent comprehension of the details and nature of the study and interfere with follow-up clinic visits
About this study
Official title: Postoperative Blood Flow Restriction Training Following Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial.
The purpose of this study is to evaluate the the ability of BFR to reduce muscle loss and improve strength after ACL reconstruction. It is hypothesized that BFR training will significantly reduce muscle loss and improve strength after ACL reconstruction. It is also hypothesized that BFR will result in improved patient reported outcomes and rates of return to sport.
Read the detailed description
Following anterior cruciate ligament (ACL) reconstruction, many patients experience weakness of the quadriceps (thigh muscles) and loss of muscle mass due to inactivity following surgery. Recent research has demonstrated that blood flow restriction (BFR) training can help reduce the loss of muscle mass and strength after surgery. Blood flow restriction training uses an inflatable cuff that prevents blood from flowing out of the leg while patients perform physical therapy exercises. This allows patients to use lighter weights while reducing muscle loss and building strength.
This will be a prospective, randomized controlled trial of patients undergoing ACL reconstruction with bone-patellar tendon-bone (BTB) autograft. Half the subjects will be randomly assigned to the BFR group and half will undergo sham BFR therapy after surgery.
Statistical Assumptions: To sufficiently power (80%) the investigation to detect a difference (alpha = 0.05) in quadriceps muscle strength (isokinetic contraction) following the completion of the BFR rehabilitation program, 19 subjects per group (38 total) would be required. However, accounting for a 20% attrition rate and an additional 20% potentially screened out at the time of surgery due to other pathology (i.e. repairable meniscus tears, cartilage defects, etc.) that alters the prescribed physical therapy protocol, this study will aim to recruit and enroll 54 subjects (27 per group).
Following ACL reconstruction surgery, subjects will complete a standardized postoperative rehabilitation program with or without BFR. The rehabilitation program will be broken into 4 phases including (1) protection, range of motion, and proprioception; (2) strength and endurance; (3) power and agility; and (4) return to sport training. Physical therapy will occur 2 times per week for 20 weeks. Subjects will attend follow-up visits at 1, 3, 6, and 12 months. Physical exam and muscle mass measurements will be performed at all visits, while strength testing will be performed at 3, 6, and 12 months.
The goal of this study is to determine the efficacy of BFR therapy in improving muscle strength and reducing loss of muscle mass following ACL reconstruction, in addition to determining the effect of BFR on patient reported outcomes and return to sport. It is anticipated that BFR will significantly reduce the loss of muscle mass and improve muscular strength compared to standard therapy. It is also expected that these subjects will have improved patient reported outcomes and greater rates of return to sport.
- Conditions
- Anterior Cruciate Ligament Injuries, ACL, Physical Therapy
- Being tested
- Blood Flow Restriction Training, Sham Blood Flow Restriction Training
- 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.
Blood Flow Restriction TrainingOther
Patients will undergo standardized postoperative rehabilitation program including blood flow restriction training. Exercises will be performed with BFR at 80% LOP.
Sham Blood Flow Restriction TrainingOther
Patients will undergo standardized postoperative rehabilitation program where exercises will be performed with sham BFR pressure of 20 mmHG.
| Study group | Role | What they receive |
|---|---|---|
| Sham Postoperative Rehabilitation | Sham comparator | Patients in this group will complete the standardized postoperative rehabilitation program with sham BFR, which is pressure of 20 mmHG. Exercises will be performed for 4 sets of 30/15/15/15 repetitions with a 30 second rest period between each set. The tourniquet cuff will remain inflated for all sets and rest periods for the selected exercise. A cadence of 2-second concentric and 2- second eccentric contractions (4 second time under tension) will be maintained for each BFR repetition. Upon completion of the exercise, the tourniquet cuff will be deflated, and a 1 minute minimum rest period will occur before moving on to another BFR exercise. Receives: Other: Sham Blood Flow Restriction Training |
| BFR Postoperative Rehabilitation | Experimental | Assigned intervention of BFR where exercises are performed with BFR at 80% limb occlusion pressure (LOP). Patients in this group will undergo blood flow restriction (BFR) training during their postoperative rehabilitation program (use an inflatable cuff that prevents blood flow from flowing out of the leg while patients perform physical therapy exercises). Exercises will be performed for 4 sets of 30/15/15/15 repetitions with a 30 second rest period between each set.16 The tourniquet cuff will remain inflated for all sets and rest periods for the selected exercise. A cadence of 2-second concentric and 2- second eccentric contractions (4 second time under tension) will be maintained for each BFR repetition. Upon completion of the exercise, the tourniquet cuff will be deflated, and a 1 minute minimum rest period will occur before moving on to another BFR exercise. Receives: Other: Blood Flow Restriction Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Quadriceps strength measured with dynamometer
Measured: 3 month follow-up
Muscle strength
Quadriceps strength measured with dynamometer
Measured: 6 month follow-up
Muscle strength
Quadriceps strength measured with dynamometer
Measured: 12 month follow-up
Quadriceps hypertrophy
Standardized circumferential leg measurements to assess quadriceps hypertrophy
Measured: 3 month follow-up
Quadriceps hypertrophy
Standardized circumferential leg measurements to assess quadriceps hypertrophy
Measured: 6 month follow-up
Quadriceps hypertrophy
Standardized circumferential leg measurements to assess quadriceps hypertrophy
Measured: 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study startDec 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Could not recruit participants for study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086030
- Sponsor's protocol ID
- 19050802
- Status last verified
- Aug 2023
- First submitted
- 4 Sep 2019
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Blood Flow Restriction Training Following Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04086030
- Acronym / sponsor ID
- 19050802
- Conditions
- Anterior Cruciate Ligament Injuries, ACL, Physical Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not recruit participants for study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Sep 2019 (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.
The purpose of this study is to evaluate the the ability of BFR to reduce muscle loss and improve strength after ACL reconstruction. It is hypothesized that BFR training will significantly reduce muscle loss and improve strength after ACL reconstruction. It is also hypothesized that BFR will result in improved patient reported outcomes and rates of return to sport.
Detailed description
Following anterior cruciate ligament (ACL) reconstruction, many patients experience weakness of the quadriceps (thigh muscles) and loss of muscle mass due to inactivity following surgery. Recent research has demonstrated that blood flow restriction (BFR) training can help reduce the loss of muscle mass and strength after surgery. Blood flow restriction training uses an inflatable cuff that prevents blood from flowing out of the leg while patients perform physical therapy exercises. This allows patients to use lighter weights while reducing muscle loss and building strength.
This will be a prospective, randomized controlled trial of patients undergoing ACL reconstruction with bone-patellar tendon-bone (BTB) autograft. Half the subjects will be randomly assigned to the BFR group and half will undergo sham BFR therapy after surgery.
Statistical Assumptions: To sufficiently power (80%) the investigation to detect a difference (alpha = 0.05) in quadriceps muscle strength (isokinetic contraction) following the completion of the BFR rehabilitation program, 19 subjects per group (38 total) would be required. However, accounting for a 20% attrition rate and an additional 20% potentially screened out at the time of surgery due to other pathology (i.e. repairable meniscus tears, cartilage defects, etc.) that alters the prescribed physical therapy protocol, this study will aim to recruit and enroll 54 subjects (27 per group).
Following ACL reconstruction surgery, subjects will complete a standardized postoperative rehabilitation program with or without BFR. The rehabilitation program will be broken into 4 phases including (1) protection, range of motion, and proprioception; (2) strength and endurance; (3) power and agility; and (4) return to sport training. Physical therapy will occur 2 times per week for 20 weeks. Subjects will attend follow-up visits at 1, 3, 6, and 12 months. Physical exam and muscle mass measurements will be performed at all visits, while strength testing will be performed at 3, 6, and 12 months.
The goal of this study is to determine the efficacy of BFR therapy in improving muscle strength and reducing loss of muscle mass following ACL reconstruction, in addition to determining the effect of BFR on patient reported outcomes and return to sport. It is anticipated that BFR will significantly reduce the loss of muscle mass and improve muscular strength compared to standard therapy. It is also expected that these subjects will have improved patient reported outcomes and greater rates of return to sport.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Postoperative Rehabilitation | Sham comparator | Other: Sham Blood Flow Restriction TrainingPatients in this group will complete the standardized postoperative rehabilitation program with sham BFR, which is pressure of 20 mmHG. Exercises will be performed for 4 sets of 30/15/15/15 repetitions with a 30 second rest period between each set. The tourniquet cuff will remain inflated for all sets and rest periods for the selected exercise. A cadence of 2-second concentric and 2- second eccentric contractions (4 second time under tension) will be maintained for each BFR repetition. Upon completion of the exercise, the tourniquet cuff will be deflated, and a 1 minute minimum rest period will occur before moving on to another BFR exercise. |
| BFR Postoperative Rehabilitation | Experimental | Other: Blood Flow Restriction TrainingAssigned intervention of BFR where exercises are performed with BFR at 80% limb occlusion pressure (LOP). Patients in this group will undergo blood flow restriction (BFR) training during their postoperative rehabilitation program (use an inflatable cuff that prevents blood flow from flowing out of the leg while patients perform physical therapy exercises). Exercises will be performed for 4 sets of 30/15/15/15 repetitions with a 30 second rest period between each set.16 The tourniquet cuff will remain inflated for all sets and rest periods for the selected exercise. A cadence of 2-second concentric and 2- second eccentric contractions (4 second time under tension) will be maintained for each BFR repetition. Upon completion of the exercise, the tourniquet cuff will be deflated, and a 1 minute minimum rest period will occur before moving on to another BFR exercise. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult patients 18-40
- English-speaking
- Primary ACL Reconstruction
- No associated procedures (meniscal repair, other ligamentous pathology), or history of deep vein thrombosis.
- Clinical and radiographic examination (MRI) consistent with an acute full thickness ACL tear and surgical consent for ACL reconstruction with a patellar tendon autograft
Key exclusion criteria (11 listed)
- Patients younger than 18 or older than 40 years of age
- Non-native English speaker
- Revision surgery or prior history of knee surgery
- Concomitant ligamentous, meniscal, or cartilage injury that would alter postoperative weight bearing status or rehabilitation protocol
- Inability to comply with the proposed follow-up clinic visits
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 |
|---|---|---|
| Blood Flow Restriction TrainingPatients will undergo standardized postoperative rehabilitation program including blood flow restriction training. Exercises will be performed with BFR at 80% LOP. | Other | BFR Postoperative Rehabilitation |
| Sham Blood Flow Restriction TrainingPatients will undergo standardized postoperative rehabilitation program where exercises will be performed with sham BFR pressure of 20 mmHG. | Other | Sham Postoperative Rehabilitation |
Primary outcome
Muscle strength
Time frame: 3 month follow-up
Quadriceps strength measured with dynamometer
Muscle strength
Time frame: 6 month follow-up
Quadriceps strength measured with dynamometer
Muscle strength
Time frame: 12 month follow-up
Quadriceps strength measured with dynamometer
Quadriceps hypertrophy
Time frame: 3 month follow-up
Standardized circumferential leg measurements to assess quadriceps hypertrophy
Quadriceps hypertrophy
Time frame: 6 month follow-up
Standardized circumferential leg measurements to assess quadriceps hypertrophy
Quadriceps hypertrophy
Time frame: 12 month follow-up
Standardized circumferential leg measurements to assess quadriceps hypertrophy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Training in people with Anterior Cruciate Ligament Injuries and ACL, run by Rush University Medical Center.
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 6 inclusion and 11 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: withdrawn, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Muscle strength (time frame: 3 month follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2023.