Anterior Cruciate Ligament Reconstruction RehabilitationNCT07311031
Effect of Blood Flow Restriction Rraining on Rehabilitation After Anterior Cruciate Ligament Reconstruction
A study testing Blood flow restriction training and Standard ACL rehabilitation in people with Anterior Cruciate Ligament Reconstruction Rehabilitation and Blood Flow Restriction (BFR) Training Effects, run by Hospital MAZ at 1 site in Spain.
Trial summary
Importance: Following anterior cruciate ligament reconstruction (ACLR), patients often experience quadriceps muscle weakness and atrophy, frequently leading to long-term complications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction Rehabilitation, Blood Flow Restriction (BFR) Training Effects
- What is being tested?
- Blood flow restriction training and Standard ACL rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 20 Dec 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (18-65 years of age); must be skeletally mature with closed physes
- Worker active
- Diagnosis of acute (<8 weeks), unilateral ACL tear with planned surgery confirmed via clinical examination and MRI
- No previous ACL injury or reconstruction on the involved limb
- Planned graft: autologous ipsilateral hamstring graft for ACL reconstruction
- Planned fixation: suspensory cortical femoral device and tibial interference screw
Who cannot join
- Completed knee dislocation or multiligament injury (PCL, MCL, LCL)
- ACL Graft diameter < 8mm
- Meniscal suture or meniscal root reattachment
- Post-surgical immobilization
- Any current or previous conditions or surgeries that might affect gait
- Pregnant
Show all 15Show fewer
- Spinal fusion
- Any implanted medical device or other contraindications for MRI
- History of deep vein thrombosis and/or varicose veins or familiy history of deep vein thrombosis
- Taking anti-coagulant drugs for any blood, cardiac or congenital disease that may cause coagulation disorders
- Taking bone and muscle metabolism-modulation drugs or muscle supplements (e.g., creatine, amino acids, whey protein,…)
- Recent inflammation, bleeding disorders, active bleeding, or infection within the lower limbs
- Diabetic or have uncontrolled hypertension
- Diminished capacity to provide informed consent
- Unfeasible to attend regular physical therapy and study visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
MAZ Hospital
Zaragoza, Zaragoza, 50009
Raul Zapata-Rodrigo, Orthopaedic Surgeon, +34620727950, raulzapatarodrigo@gmail.com
About this study
Official title: Effect of Blood Flow Restriction Training on Quadriceps Muscle Strength, Knee Biomechanics and Rehabilitation After Anterior Cruciate Ligament Reconstruction in Active Workers
Importance: Following anterior cruciate ligament reconstruction (ACLR), patients often experience quadriceps muscle weakness and atrophy, frequently leading to long-term complications. A promising rehabilitation program based on blood flow restriction training (BFRT) seems to be particularly valuable for patients who may be unable to train with heavy loads due recent surgery. Previous studies have demonstrated that BFRT promotes strength gains and muscle mass increases, with adaptations comparable to traditional high-intensity training, despite using low-load resistance exercises.
Objective: to evaluate the effect of blood flow restriction training on quadriceps strength and knee biomechanics in a 4-month rehabilitation program of patients who have had an ACL reconstruction.
Read more
Design: The study will be a two-arm superiority randomized controlled clinical trial.
Setting: The trial will be conducted at a work-related injuries specialised hospital, MAZ Hospital, Zaragoza, Spain.
Participants: Participants will be active workers who have suffered an acute ACL tear and they have undergone ACL reconstruction (n=60).
Intervention: Patients will recieve a 14-16-week supervised accelerated early rehabilitation protocol; one group will complete it applying blood flow restriction training and the other will not.
Main Outcome and Measure: The primary outcomes will be peak quadriceps strength and rate of torque development measured both isometrically and isokinetcally with a Isokinetic Dynamometer CON-TREX MG.
Limitations: Potential limitations include patients and physiotherapists are not blinded.
Conclusions: The focus of the research will examine the impact of blood flow restriction rehabilitation on patients who have undergone ACLR.
Relevance: The study has potential to restore quadriceps strength to a greater extent than standard rehabilitation protocol. Moreover, patients will spend less time in the rehabilitation process to return to work compared to standard care.
- Conditions
- Anterior Cruciate Ligament Reconstruction Rehabilitation, Blood Flow Restriction (BFR) Training Effects
- Being tested
- Blood flow restriction training, Standard ACL rehabilitation
- Keywords
- KAATSU, Knee injury, ACL rehabilitation
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction trainingOther
BFRT consists of a pressurized cuff that is applied to the proximal thigh in order to partially occlude blood flow while the patient exercises. It is believed that the accumulated effects of fatigue, mechanical tension, metabolic stress and reactive hyperaemia contribute to promoting adaptation of the quadriceps with minimal strain. Therefore, patients can train at reduced loads and may receive the same training benefits as if they were training with high loads.
Standard ACL rehabilitationOther
A 14-16-week supervised accelerated early rehabilitation protocol was selected based on previous evidence.8 It is characterised by early unrestricted motion and weight-bearing, without the use of an immobilising brace and commencing early strength training.
| Study group | Role | What they receive |
|---|---|---|
| BFRT rehabilitation group | Experimental | Receive standard ACL physical therapy plus blood flow restriction training Receives: Other: Blood flow restriction training; Other: Standard ACL rehabilitation |
| Standard rehabilitation group | Active comparator | Receive standard ACL physical therapy Receives: Other: Standard ACL rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps strength
Peak quadriceps strength
Measured: From enrollment to the end of treatment at 14 weeks
Quadriceps strength
Rate of torque
Measured: From enrollment to the end of treatment at 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament Reconstruction RehabilitationStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital MAZ
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raul Zapata Rodrigo, Hospital MAZ
- Investigators
- Jose Antonio Casajus Mallen, University professor, Study chair, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311031
- Sponsor's protocol ID
- MAZ Hospital
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Trained researchers will collect data from MAZ Hospital. All information collected during this trial will always be protected and securely stored by the lead researcher. The lead researcher will assign a secure locker in his office to store all investigation documents. Additionally, all electronic material will be safely stored and backed up on the researcher's computer equipment with a secure password.
Publications
Erickson LN, Lucas KCH, Davis KA, Jacobs CA, Thompson KL, Hardy PA, Andersen AH, Fry CS, Noehren BW. Effect of Blood Flow Restriction Training on Quadriceps Muscle Strength, Morphology, Physiology, and Knee Biomechanics Before and After Anterior Cruciate Ligament Reconstruction: Protocol for a Randomized Clinical Trial. Phys Ther. 2019 Aug 1;99(8):1010-1019. doi: 10.1093/ptj/pzz062.
PubMed 30951598Gopinatth V, Garcia JR, Reid IK, Knapik DM, Verma NN, Chahla J. Blood Flow Restriction Enhances Recovery After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2025 Apr;41(4):1048-1060. doi: 10.1016/j.arthro.2024.05.032. Epub 2024 Jun 16.
PubMed 38889851Erickson LN, Owen MK, Casadonte KR, Janatova T, Lucas K, Spencer K, Brightwell BD, Graham MC, White MS, Thomas NT, Latham CM, Jacobs CA, Conley CE, Thompson KL, Johnson DL, Hardy PA, Fry CS, Noehren B. The Efficacy of Blood Flow Restriction Training to Improve Quadriceps Muscle Function after Anterior Cruciate Ligament Reconstruction. Med Sci Sports Exerc. 2025 Feb 1;57(2):227-237. doi: 10.1249/MSS.0000000000003573. Epub 2024 Oct 1.
PubMed 39350350Mather RC 3rd, Koenig L, Kocher MS, Dall TM, Gallo P, Scott DJ, Bach BR Jr, Spindler KP; MOON Knee Group. Societal and economic impact of anterior cruciate ligament tears. J Bone Joint Surg Am. 2013 Oct 2;95(19):1751-9. doi: 10.2106/JBJS.L.01705.
PubMed 24088967Matar HE, Platt SR, Bloch BV, James PJ, Cameron HU. A Systematic Review of Randomized Controlled Trials in Anterior Cruciate Ligament Reconstruction: Standard Techniques Are Comparable (299 Trials With 25,816 Patients). Arthrosc Sports Med Rehabil. 2021 May 14;3(4):e1211-e1226. doi: 10.1016/j.asmr.2021.03.017. eCollection 2021 Aug.
PubMed 34430902
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Blood Flow Restriction Training on Quadriceps Muscle Strength, Knee Biomechanics and Rehabilitation After Anterior Cruciate Ligament Reconstruction in Active Workers
- ClinicalTrials.gov ID
- NCT07311031
- Acronym / sponsor ID
- MAZ Hospital
- Conditions
- Anterior Cruciate Ligament Reconstruction Rehabilitation, Blood Flow Restriction (BFR) Training Effects
- Keywords
- KAATSU, Knee injury, ACL rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital MAZUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 30 Dec 2025 (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.
Importance: Following anterior cruciate ligament reconstruction (ACLR), patients often experience quadriceps muscle weakness and atrophy, frequently leading to long-term complications. A promising rehabilitation program based on blood flow restriction training (BFRT) seems to be particularly valuable for patients who may be unable to train with heavy loads due recent surgery. Previous studies have demonstrated that BFRT promotes strength gains and muscle mass increases, with adaptations comparable to traditional high-intensity training, despite using low-load resistance exercises.
Objective: to evaluate the effect of blood flow restriction training on quadriceps strength and knee biomechanics in a 4-month rehabilitation program of patients who have had an ACL reconstruction.
Design: The study will be a two-arm superiority randomized controlled clinical trial.
Setting: The trial will be conducted at a work-related injuries specialised hospital, MAZ Hospital, Zaragoza, Spain.
Participants: Participants will be active workers who have suffered an acute ACL tear and they have undergone ACL reconstruction (n=60).
Intervention: Patients will recieve a 14-16-week supervised accelerated early rehabilitation protocol; one group will complete it applying blood flow restriction training and the other will not.
Main Outcome and Measure: The primary outcomes will be peak quadriceps strength and rate of torque development measured both isometrically and isokinetcally with a Isokinetic Dynamometer CON-TREX MG.
Limitations: Potential limitations include patients and physiotherapists are not blinded.
Conclusions: The focus of the research will examine the impact of blood flow restriction rehabilitation on patients who have undergone ACLR.
Relevance: The study has potential to restore quadriceps strength to a greater extent than standard rehabilitation protocol. Moreover, patients will spend less time in the rehabilitation process to return to work compared to standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFRT rehabilitation group | Experimental | Other: Blood flow restriction training, Other: Standard ACL rehabilitationReceive standard ACL physical therapy plus blood flow restriction training |
| Standard rehabilitation group | Active comparator | Other: Standard ACL rehabilitationReceive standard ACL physical therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female (18-65 years of age); must be skeletally mature with closed physes
- Worker active
- Diagnosis of acute (<8 weeks), unilateral ACL tear with planned surgery confirmed via clinical examination and MRI
- No previous ACL injury or reconstruction on the involved limb
- Planned graft: autologous ipsilateral hamstring graft for ACL reconstruction
Key exclusion criteria (15 listed)
- Completed knee dislocation or multiligament injury (PCL, MCL, LCL)
- ACL Graft diameter < 8mm
- Meniscal suture or meniscal root reattachment
- Post-surgical immobilization
- Any current or previous conditions or surgeries that might affect gait
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 trainingBFRT consists of a pressurized cuff that is applied to the proximal thigh in order to partially occlude blood flow while the patient exercises. It is believed that the accumulated effects of fatigue, mechanical tension, metabolic stress and reactive hyperaemia contribute to promoting adaptation of the quadriceps with minimal strain. Therefore, patients can train at reduced loads and may receive the same training benefits as if they were training with high loads. | Other | BFRT rehabilitation group |
| Standard ACL rehabilitationA 14-16-week supervised accelerated early rehabilitation protocol was selected based on previous evidence.8 It is characterised by early unrestricted motion and weight-bearing, without the use of an immobilising brace and commencing early strength training. | Other | BFRT rehabilitation group, Standard rehabilitation group |
Primary outcome
Quadriceps strength
Time frame: From enrollment to the end of treatment at 14 weeks
Peak quadriceps strength
Quadriceps strength
Time frame: From enrollment to the end of treatment at 14 weeks
Rate of torque
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Background: PubMed 30951598Erickson LN, Lucas KCH, Davis KA, Jacobs CA, Thompson KL, Hardy PA, Andersen AH, Fry CS, Noehren BW. Effect of Blood Flow Restriction Training on Quadriceps Muscle Strength, Morphology, Physiology, and Knee Biomechanics Before and After Anterior Cruciate Ligament Reconstruction: Protocol for a Randomized Clinical Trial. Phys Ther. 2019 Aug 1;99(8):1010-1019. doi: 10.1093/ptj/pzz062.
- Background: PubMed 38889851Gopinatth V, Garcia JR, Reid IK, Knapik DM, Verma NN, Chahla J. Blood Flow Restriction Enhances Recovery After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2025 Apr;41(4):1048-1060. doi: 10.1016/j.arthro.2024.05.032. Epub 2024 Jun 16.
- Background: PubMed 39350350Erickson LN, Owen MK, Casadonte KR, Janatova T, Lucas K, Spencer K, Brightwell BD, Graham MC, White MS, Thomas NT, Latham CM, Jacobs CA, Conley CE, Thompson KL, Johnson DL, Hardy PA, Fry CS, Noehren B. The Efficacy of Blood Flow Restriction Training to Improve Quadriceps Muscle Function after Anterior Cruciate Ligament Reconstruction. Med Sci Sports Exerc. 2025 Feb 1;57(2):227-237. doi: 10.1249/MSS.0000000000003573. Epub 2024 Oct 1.
- Background: PubMed 24088967Mather RC 3rd, Koenig L, Kocher MS, Dall TM, Gallo P, Scott DJ, Bach BR Jr, Spindler KP; MOON Knee Group. Societal and economic impact of anterior cruciate ligament tears. J Bone Joint Surg Am. 2013 Oct 2;95(19):1751-9. doi: 10.2106/JBJS.L.01705.
- Background: PubMed 34430902Matar HE, Platt SR, Bloch BV, James PJ, Cameron HU. A Systematic Review of Randomized Controlled Trials in Anterior Cruciate Ligament Reconstruction: Standard Techniques Are Comparable (299 Trials With 25,816 Patients). Arthrosc Sports Med Rehabil. 2021 May 14;3(4):e1211-e1226. doi: 10.1016/j.asmr.2021.03.017. eCollection 2021 Aug.
- Individual participant dataSharing planned: Yes. Trained researchers will collect data from MAZ Hospital. All information collected during this trial will always be protected and securely stored by the lead researcher. The lead researcher will assign a secure locker in his office to store all investigation documents. Additionally, all electronic material will be safely stored and backed up on the researcher's computer equipment with a secure password.
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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.
Jose Antonio Casajus Mallen, University professor study chair
Universidad de Zaragoza
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 training and Standard ACL rehabilitation in people with Anterior Cruciate Ligament Reconstruction Rehabilitation and Blood Flow Restriction (BFR) Training Effects, run by Hospital MAZ at 1 site in Spain.
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 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: opening soon, as of the sponsor's last update on 5 Jan 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raul Zapata-Rodrigo, Orthopaedic Surgeon (+34620727950, raulzapatarodrigo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps strength (time frame: From enrollment to the end of treatment at 14 weeks). The study lists 2 primary outcomes in all. 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 NCT07311031, which also lists 5 linked publications.
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 5 Jan 2026.