ACL InjuryNCT04302558
Low-Intensity Blood Flow Restriction Training as a Pre-Operative Rehabilitative Modality to Improve Post-Operative Outcomes for ACL Reconstruction
A study testing Exercise Blood Flow Restriction training in people with ACL Injury, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to find out whether the use of low-intensity strength exercises during the 2 weeks before surgery, and while the blood flow to the leg is reduced, will improve the outcomes after surgery to repair an injured ligament of the knee. Read more about this study
- Who is it for?
- Ages 13 to 40 years
- Conditions the study is for
- ACL Injury
- What is being tested?
- Exercise Blood Flow Restriction training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2020to 4 May 2022
- 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 13 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects must be between 13 and 40 years old
- Subjects must have been previously diagnosed with a tear of the anterior cruciate ligament in one of the lower extremities that requires surgical reconstruction
- Subjects must be able to understand study procedures and comply with them for the entire duration of the study
- Subjects must have normal contralateral limb strength
Who cannot join
- Subjects with any personal history of deep vein thrombosis or with such history in their immediate family
- Subjects who have any multi-ligamentous injuries to the knee that require modified post-operative unloading
- Subjects who have history of previous anterior cruciate ligament reconstructions in either the affected or unaffected leg
- Subjects with an inability or unwillingness of individual or legal guardian to give written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Researchers are trying to find out whether the use of low-intensity strength exercises during the 2 weeks before surgery, and while the blood flow to the leg is reduced, will improve the outcomes after surgery to repair an injured ligament of the knee.
- Conditions
- ACL Injury
- Being tested
- Exercise Blood Flow Restriction training, SHAM Exercise 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.
Exercise Blood Flow Restriction trainingBehavioural
While exercising, an Inflatable cuff, similar to a blood pressure cuff, is applied to the proximal aspect of the femur of the affected lower extremity inflated to occlude blood flow
SHAM Exercise Blood Flow Restriction trainingBehavioural
While exercising Inflatable cuff, similar to a blood pressure cuff, applied to the proximal aspect of the femur of the affected lower extremity with limited inflation pressure to not occlude blood flow
| Study group | Role | What they receive |
|---|---|---|
| Blood Flow Restriction (BFR) group | Experimental | Subjects previously diagnosed with a torn ACL who have yet to undergo surgical reconstruction and pre-operative rehabilitation will do a series of low-intensity strength exercises while the blood flow to the leg is reduced by a blood flow restriction cuff. Receives: Behavioral: Exercise Blood Flow Restriction training |
| SHAM Blood Flow Restriction (BFR) group | Sham comparator | Subjects previously diagnosed with a torn ACL who have yet to undergo surgical reconstruction and pre-operative rehabilitation will do a series of low-intensity strength exercises while a blood flow restriction cuff is applied but inflation pressure will be limited Receives: Behavioral: SHAM Exercise Blood Flow Restriction training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle diameter (hypertrophy)
Measured using ultrasound images of the musculature and soft tissue of the quadriceps femoris
Measured: 2 weeks pre-operative, 8-10 days post-operative
Secondary outcomes (1)
Change in muscle strength
Muscle strength will be measured in subjects as the percent strength of the injured leg compared to the non-injured leg based on handheld dynamometer and the number of leg presses performed at the 1-rep maximum
Measured: 2 weeks pre-operative, 4 weeks pre-operative, 8 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start18 Dec 2020
- Primary completion4 May 2022
- Study completion4 May 2022
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.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anikar Chhabra, Mayo Clinic
- Investigators
- Anikar Chhabra, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302558
- Sponsor's protocol ID
- 19-008473
- Status last verified
- Feb 2023
- First submitted
- 8 Mar 2020
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McGurren DP, Glattke KE, Chhabra A, Boddu SP, Poon SK, Flug JA, Brinkman JC, Goetzinger S, Lee JE, Nocella A, Rogge J, De Luigi AJ. Assessment of Interrater Reliability for Interpretation of Musculoskeletal Ultrasound Imaging of the Quadriceps Femoris. Am J Phys Med Rehabil. 2025 Oct 1;104(10):906-910. doi: 10.1097/PHM.0000000000002731. Epub 2025 Mar 6.
PubMed 40101801
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Intensity Blood Flow Restriction Training as a Pre-Operative Rehabilitative Modality to Improve Post-Operative Outcomes for ACL Reconstruction
- ClinicalTrials.gov ID
- NCT04302558
- Acronym / sponsor ID
- 19-008473
- Conditions
- ACL Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 10 Mar 2020 (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.
Researchers are trying to find out whether the use of low-intensity strength exercises during the 2 weeks before surgery, and while the blood flow to the leg is reduced, will improve the outcomes after surgery to repair an injured ligament of the knee.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction (BFR) group | Experimental | Behavioral: Exercise Blood Flow Restriction trainingSubjects previously diagnosed with a torn ACL who have yet to undergo surgical reconstruction and pre-operative rehabilitation will do a series of low-intensity strength exercises while the blood flow to the leg is reduced by a blood flow restriction cuff. |
| SHAM Blood Flow Restriction (BFR) group | Sham comparator | Behavioral: SHAM Exercise Blood Flow Restriction trainingSubjects previously diagnosed with a torn ACL who have yet to undergo surgical reconstruction and pre-operative rehabilitation will do a series of low-intensity strength exercises while a blood flow restriction cuff is applied but inflation pressure will be limited |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Subjects must be between 13 and 40 years old
- Subjects must have been previously diagnosed with a tear of the anterior cruciate ligament in one of the lower extremities that requires surgical reconstruction
- Subjects must be able to understand study procedures and comply with them for the entire duration of the study
- Subjects must have normal contralateral limb strength
Key exclusion criteria (4 listed)
- Subjects with any personal history of deep vein thrombosis or with such history in their immediate family
- Subjects who have any multi-ligamentous injuries to the knee that require modified post-operative unloading
- Subjects who have history of previous anterior cruciate ligament reconstructions in either the affected or unaffected leg
- Subjects with an inability or unwillingness of individual or legal guardian to give written informed consent
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 |
|---|---|---|
| Exercise Blood Flow Restriction trainingWhile exercising, an Inflatable cuff, similar to a blood pressure cuff, is applied to the proximal aspect of the femur of the affected lower extremity inflated to occlude blood flow | Behavioural | Blood Flow Restriction (BFR) group |
| SHAM Exercise Blood Flow Restriction trainingWhile exercising Inflatable cuff, similar to a blood pressure cuff, applied to the proximal aspect of the femur of the affected lower extremity with limited inflation pressure to not occlude blood flow | Behavioural | SHAM Blood Flow Restriction (BFR) group |
Primary outcome
Change in muscle diameter (hypertrophy)
Time frame: 2 weeks pre-operative, 8-10 days post-operative
Measured using ultrasound images of the musculature and soft tissue of the quadriceps femoris
1 secondary outcome
Change in muscle strength
Time frame: 2 weeks pre-operative, 4 weeks pre-operative, 8 weeks post-operative
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 3 Feb 2023.
- Derived from this study: PubMed 40101801McGurren DP, Glattke KE, Chhabra A, Boddu SP, Poon SK, Flug JA, Brinkman JC, Goetzinger S, Lee JE, Nocella A, Rogge J, De Luigi AJ. Assessment of Interrater Reliability for Interpretation of Musculoskeletal Ultrasound Imaging of the Quadriceps Femoris. Am J Phys Med Rehabil. 2025 Oct 1;104(10):906-910. doi: 10.1097/PHM.0000000000002731. Epub 2025 Mar 6.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for ACL Injury
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
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
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
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.
Anikar Chhabra, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Blood Flow Restriction training in people with ACL Injury, run by Mayo Clinic 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 4 inclusion and 4 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 3 Feb 2023. 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. 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?
Change in muscle diameter (hypertrophy) (time frame: 2 weeks pre-operative, 8-10 days post-operative). 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 NCT04302558, 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 3 Feb 2023.