ACL InjuryBFRACLNCT06342063
The Effects of Preoperative Blood Flow Restriction Training in Patients Undergoing ACL Reconstruction
A study testing Blood Flow Restriction Therapy in people with ACL Injury and Sports Physical Therapy, run by Women's College Hospital at 1 site in Canada.
Trial summary
This prospective feasibility study is designed to assess pre-operative BFR in patients awaiting ACL reconstruction. This study will serve the following: (1) to determine if BFR improves strength testing prior to surgery and (2) to determine if BFR reduces QF muscle group atrophy prior to surgery. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- ACL Injury, Sports Physical Therapy
- What is being tested?
- Blood Flow Restriction Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2021to 31 Jan 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sagittal Knee instability caused by ACL tear requiring surgical reconstruction
- Minimum 4 weeks since the time of injury
- Age 18 to 50 years
- Range of motion required
- Active extension deficit <5o, Active flexion > 120o
- No previous surgery to affected knee
Who cannot join
- Functional impairment (neuro disease, gait abnormality, ambulatory aids at baseline)
- Severe spine or lower limb injuries
- Comorbidities including cardiovascular, respiratory or metabolic disease, blood coagulation disorders, current smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Preoperative Blood Flow Restriction Training in Patients Undergoing ACL Reconstruction: A Pilot Randomized Control Trial
This prospective feasibility study is designed to assess pre-operative BFR in patients awaiting ACL reconstruction. This study will serve the following: (1) to determine if BFR improves strength testing prior to surgery and (2) to determine if BFR reduces QF muscle group atrophy prior to surgery. Additionally, preliminary results on pre-operative clinical and quality of life scores will be collected. If this study shows encouraging results, it will serve as a template for a more comprehensive randomized control trial.
Read the detailed description
Quadriceps femoris (QF) muscle function is an integral factor in the rehabilitation and overall outcome after lower extremity injury or surgical intervention. Atrophy of this muscle group is a common finding in patients undergoing anterior cruciate ligament (ACL) reconstruction. This is due to the immobility prior to surgery, vascular ischemia caused by a tourniquet intra-operatively and inability to perform high load strength training in the early post-operative period. A deficit in QF muscle strength can result in excessive joint loading and be a contributing factor in the early onset of osteoarthritis of the knee. It should be noted that a loss of strength in this primary knee extensor mechanism muscle group can persist for up to 2 years after surgery. Thus, the reduction of QF atrophy and maintenance of strength during an intervention such as an ACL reconstruction has large implications for the overall post-operative outcome and natural history of the knee joint.
In order to combat the challenges of muscle atrophy for patients with an ACL injury, blood flow restriction (BFR) training has been shown to have beneficial effects in the post-operative period specifically. The process of using BFR therapy involves the application of an extremity tourniquet to occlude venous outflow and restrict arterial inflow. Thus, an anaerobic environment is created to promote muscle hypertrophy by having cells upregulate cell signalling, protein synthesis and ultimately myogenic proliferation. The use of BFR during lower extremity rehabilitation has shown that its simultaneous use with low load resistance training can have similar hypertrophic effects to isolated high load resistance training. This is ideal for patients who are initially unable to perform high intensity exercises shortly after an ACL reconstruction surgery, but are attempting to reduce overall QF atrophy.
However, the use of BFR in the pre-operative period has yet to be well established. Preconditioning with an ischemic environment may provide an effective way to reduce QF atrophy with low load exercises while awaiting surgery. Additionally, having a period of sensitization with anaerobic conditions prior to surgery, may provide some resistance to the damaging effects of a tourniquet intra-operatively. The limited studies that have attempted to use BFR therapy prior to ACL surgery have had short intervention periods, small sample sizes and outcome variables that have not assessed overall clinical outcome. If BFR in the pre-operative setting can be shown to provide beneficial effects, it will be a valuable tool in maximizing the overall outcome of patients undergoing ACL reconstruction.
This prospective feasibility study has been designed to assess pre-operative BFR in patients awaiting ACL reconstruction. This study will serve the following: (1) to determine if BFR improves strength testing prior to surgery and (2) to determine if BFR reduces QF muscle group atrophy prior to surgery. Additionally, preliminary results on pre-operative clinical and quality of life scores will be collected. If this study shows encouraging results, it will serve as a template for a more comprehensive randomized control trial.
- Conditions
- ACL Injury, Sports Physical Therapy
- Being tested
- Blood Flow Restriction Therapy, Blood Flow Restriction Therapy Sham
- Keywords
- Blood Flow Restriction, Preconditioning, Rehab, ACL
- 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 TherapyDevice
Also called BFR
Patients wear a personalized tourniquet pressure system on their involved thigh while they perform a series of leg press machine exercises. This tourniquet is inflated.
Blood Flow Restriction Therapy ShamDevice
Also called Sham BFR Comparison Group
Patients wear a personalized tourniquet pressure system on their involved thigh while they perform a series of leg press machine exercises. This tourniquet is not inflated.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy with Blood Flow Restriction Group | Active comparator | This group underwent a physiotherapy protocol while using Blood Flow Restriction adjunctive therapy prior to ACL reconstruction. Receives: Device: Blood Flow Restriction Therapy |
| Physiotherapy without Blood Flow Restriction Group | Sham comparator | This group underwent a physiotherapy protocol without using Blood Flow Restriction adjunctive therapy prior to ACL reconstruction. Receives: Device: Blood Flow Restriction Therapy Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex Strength Testing
Quadriceps and Hamstring Muscle Strength and Endurance testing. Maximal peak torque (FT-LBS) was recorded for both knee flexion and extension at 60 degrees / second (indicative of strength) and 180 degrees / second (indicative of endurance).
Measured: Baseline testing 1 day prior to physiotherapy initiation and Post intervention testing performed 1 day after physiotherapy completion but before ACL surgery.
Secondary outcomes (2)
Short Form Health Survey 12 (SF-12)
Patient Reported Outcome Measure. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: Baseline testing 1 day prior to physiotherapy initiation and Post intervention testing performed 1 day after physiotherapy completion but before ACL surgery.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient Reported Outcome Measure. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Measured: Baseline testing 1 day prior to physiotherapy initiation and Post intervention testing performed 1 day after physiotherapy completion but before ACL surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Apr 2021
- Primary completion31 Oct 2023
- Study completion31 Jan 2024
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 ACL InjuryStudies 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
- Model description
- Patients were recruited and randomized to one of the two treatment arms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Theodoropoulos, MD, FRCSC, Principal investigator, Dovigi Sports Medicine Clinic, Mount Sinai Hospital, Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342063
- Sponsor's protocol ID
- 20-0070-E
- Acronym
- BFRACL
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wengle L, Migliorini F, Leroux T, Chahal J, Theodoropoulos J, Betsch M. The Effects of Blood Flow Restriction in Patients Undergoing Knee Surgery: A Systematic Review and Meta-analysis. Am J Sports Med. 2022 Aug;50(10):2824-2833. doi: 10.1177/03635465211027296. Epub 2021 Aug 18.
PubMed 34406084
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Preoperative Blood Flow Restriction Training in Patients Undergoing ACL Reconstruction: A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06342063
- Acronym / sponsor ID
- BFRACL / 20-0070-E
- Conditions
- ACL Injury, Sports Physical Therapy
- Keywords
- Blood Flow Restriction, Preconditioning, Rehab, ACL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 2 Apr 2024 (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.
This prospective feasibility study is designed to assess pre-operative BFR in patients awaiting ACL reconstruction. This study will serve the following: (1) to determine if BFR improves strength testing prior to surgery and (2) to determine if BFR reduces QF muscle group atrophy prior to surgery. Additionally, preliminary results on pre-operative clinical and quality of life scores will be collected. If this study shows encouraging results, it will serve as a template for a more comprehensive randomized control trial.
Detailed description
Quadriceps femoris (QF) muscle function is an integral factor in the rehabilitation and overall outcome after lower extremity injury or surgical intervention. Atrophy of this muscle group is a common finding in patients undergoing anterior cruciate ligament (ACL) reconstruction. This is due to the immobility prior to surgery, vascular ischemia caused by a tourniquet intra-operatively and inability to perform high load strength training in the early post-operative period. A deficit in QF muscle strength can result in excessive joint loading and be a contributing factor in the early onset of osteoarthritis of the knee. It should be noted that a loss of strength in this primary knee extensor mechanism muscle group can persist for up to 2 years after surgery. Thus, the reduction of QF atrophy and maintenance of strength during an intervention such as an ACL reconstruction has large implications for the overall post-operative outcome and natural history of the knee joint.
In order to combat the challenges of muscle atrophy for patients with an ACL injury, blood flow restriction (BFR) training has been shown to have beneficial effects in the post-operative period specifically. The process of using BFR therapy involves the application of an extremity tourniquet to occlude venous outflow and restrict arterial inflow. Thus, an anaerobic environment is created to promote muscle hypertrophy by having cells upregulate cell signalling, protein synthesis and ultimately myogenic proliferation. The use of BFR during lower extremity rehabilitation has shown that its simultaneous use with low load resistance training can have similar hypertrophic effects to isolated high load resistance training. This is ideal for patients who are initially unable to perform high intensity exercises shortly after an ACL reconstruction surgery, but are attempting to reduce overall QF atrophy.
However, the use of BFR in the pre-operative period has yet to be well established. Preconditioning with an ischemic environment may provide an effective way to reduce QF atrophy with low load exercises while awaiting surgery. Additionally, having a period of sensitization with anaerobic conditions prior to surgery, may provide some resistance to the damaging effects of a tourniquet intra-operatively. The limited studies that have attempted to use BFR therapy prior to ACL surgery have had short intervention periods, small sample sizes and outcome variables that have not assessed overall clinical outcome. If BFR in the pre-operative setting can be shown to provide beneficial effects, it will be a valuable tool in maximizing the overall outcome of patients undergoing ACL reconstruction.
This prospective feasibility study has been designed to assess pre-operative BFR in patients awaiting ACL reconstruction. This study will serve the following: (1) to determine if BFR improves strength testing prior to surgery and (2) to determine if BFR reduces QF muscle group atrophy prior to surgery. Additionally, preliminary results on pre-operative clinical and quality of life scores will be collected. If this study shows encouraging results, it will serve as a template for a more comprehensive randomized control trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were recruited and randomized to one of the two treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy with Blood Flow Restriction Group | Active comparator | Device: Blood Flow Restriction TherapyThis group underwent a physiotherapy protocol while using Blood Flow Restriction adjunctive therapy prior to ACL reconstruction. |
| Physiotherapy without Blood Flow Restriction Group | Sham comparator | Device: Blood Flow Restriction Therapy ShamThis group underwent a physiotherapy protocol without using Blood Flow Restriction adjunctive therapy prior to ACL reconstruction. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sagittal Knee instability caused by ACL tear requiring surgical reconstruction
- Minimum 4 weeks since the time of injury
- Age 18 to 50 years
Key exclusion criteria (3 listed)
- Functional impairment (neuro disease, gait abnormality, ambulatory aids at baseline)
- Severe spine or lower limb injuries
- Comorbidities including cardiovascular, respiratory or metabolic disease, blood coagulation disorders, current smoker
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 TherapyAlso: BFRPatients wear a personalized tourniquet pressure system on their involved thigh while they perform a series of leg press machine exercises. This tourniquet is inflated. | Device | Physiotherapy with Blood Flow Restriction Group |
| Blood Flow Restriction Therapy ShamAlso: Sham BFR Comparison GroupPatients wear a personalized tourniquet pressure system on their involved thigh while they perform a series of leg press machine exercises. This tourniquet is not inflated. | Device | Physiotherapy without Blood Flow Restriction Group |
Primary outcome
Biodex Strength Testing
Time frame: Baseline testing 1 day prior to physiotherapy initiation and Post intervention testing performed 1 day after physiotherapy completion but before ACL surgery.
Quadriceps and Hamstring Muscle Strength and Endurance testing. Maximal peak torque (FT-LBS) was recorded for both knee flexion and extension at 60 degrees / second (indicative of strength) and 180 degrees / second (indicative of endurance).
2 secondary outcomes
Short Form Health Survey 12 (SF-12)
Time frame: Baseline testing 1 day prior to physiotherapy initiation and Post intervention testing performed 1 day after physiotherapy completion but before ACL surgery.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline testing 1 day prior to physiotherapy initiation and Post intervention testing performed 1 day after physiotherapy completion but before ACL 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 2 Apr 2024.
- Background: PubMed 34406084Wengle L, Migliorini F, Leroux T, Chahal J, Theodoropoulos J, Betsch M. The Effects of Blood Flow Restriction in Patients Undergoing Knee Surgery: A Systematic Review and Meta-analysis. Am J Sports Med. 2022 Aug;50(10):2824-2833. doi: 10.1177/03635465211027296. Epub 2021 Aug 18.
- Individual participant dataSharing planned: No
Related trials for ACL Injury
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
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Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
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.
John Theodoropoulos, MD, FRCSC principal investigator
Dovigi Sports Medicine Clinic, Mount Sinai Hospital, Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Therapy in people with ACL Injury and Sports Physical Therapy, run by Women's College Hospital at 1 site in Canada.
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 3 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 2 Apr 2024. 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 Canada. 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. 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 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?
Biodex Strength Testing (time frame: Baseline testing 1 day prior to physiotherapy initiation and Post intervention testing performed 1 day after physiotherapy completion but before ACL 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 NCT06342063, 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 2 Apr 2024.