Blood Flow Restriction TrainingNCT07142889
BFR Training for Post ACLR
A study testing Low load-BFRt and High load-Eccentric training in people with Blood Flow Restriction Training and Patella Position, run by Udayana University at 1 site in Indonesia.
Trial summary
This randomized clinical trial is designed to compare three different rehabilitation methods for patients who have undergone anterior cruciate ligament (ACL) reconstruction. The study aims to determine whether low-load blood flow restriction training (LL-BFRt) is more effective than high-load eccentric training… Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Blood Flow Restriction Training, Patella Position, Muscle Morphology
- What is being tested?
- Low load-BFRt and High load-Eccentric training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2025to 1 Sep 2026
- 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 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 15-35 years old.
- History of a unilateral ACL injury, underwent ACL reconstruction surgery more than 6 months ago, and completed rehabilitation with physiotherapy.
- Adults participating in recreational or competitive sports at a minimum of level 3 on the Tegner Activity Scale.
- No prior history of a grade 3 sprain/strain injury to other tissues in the knee and foot.
- No recurring knee injuries after the ACL reconstruction surgery.
- Willing to be a research subject from start to finish by signing an informed consent form.
Who cannot join
- Hypertension, circulatory disorders, sickle cell anemia, obesity, diabetes, kidney disorders, venous thromboembolism, cancer, and tumors are contraindications for BFR application.
- Experiencing a disability or being disabled.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Physical therapy laboratory, College of Medicine, Universitas Udayana and ROM Physiotherapy Private Clinic Denpasar
Denpasar, Bali, 80232
I Putu Gde Surya Adhitya, +6288975003567, surya_adhitya@unud.ac.id
About this study
Official title: The Effectiveness of Blood Flow Restriction Training on Patellar Position, Muscle Morphology, and Lower Limb Function in Patients After Anterior Cruciate Ligament Reconstruction
This randomized clinical trial is designed to compare three different rehabilitation methods for patients who have undergone anterior cruciate ligament (ACL) reconstruction. The study aims to determine whether low-load blood flow restriction training (LL-BFRt) is more effective than high-load eccentric training (HL-Et) and a sham LL-BFRt in improving three key areas: patellar position, muscle morphology, and leg function.
Study Design and Interventions
Read more
Participants will be randomly assigned to one of the three intervention groups. All groups will perform eccentric exercises, including single leg squats, single leg deadlifts, lateral step downs, and single leg calf raises. The key differences lie in the load and the use of blood flow restriction:
LL-BFRt Group: Participants will train at 30% of their repetition maximum (RM) while a cuff restricts blood flow to 70% of their artery occlusion pressure (AOP).
HL-Et Group: Participants will train at a higher intensity, using 70% of their repetition maximum (RM), with no blood flow restriction.
Sham LL-BFRt Group: Participants will perform the same exercises as the LL-BFRt group at 30% of their RM, but the cuff will not be inflated to a pressure that restricts blood flow.
After the training period, the researchers will compare the outcomes across all three groups to see which method leads to the most significant improvements in patella position, muscle morphology, and leg function.
- Conditions
- Blood Flow Restriction Training, Patella Position, Muscle Morphology, Anterior Cruciate Ligament Reconstruction, Leg Function
- Being tested
- Low load-BFRt, Sham Low load-BFRt, High load-Eccentric training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low load-BFRtProcedure or surgery
The participants' two legs will be subjected to 70% arterial occlusion pressure when the physical therapist applies the BFR cuffs. After that, participants will be required to complete eccentric exercises with a maximum repetition count of 30%, such as single leg squat, single leg deadlift, lateral step down, dan single leg calf raise.
Sham Low load-BFRtProcedure or surgery
The participants' two legs will be subjected to 10% arterial occlusion pressure when the physical therapist applies the BFR cuffs. After that, participants will be required to complete eccentric exercises with a maximum repetition count of 30%, such as single leg squat, single leg deadlift, lateral step down, dan single leg calf raise.
High load-Eccentric trainingProcedure or surgery
The physical therapist will instruct the participants to complete eccentric exercises at a maximum of 70% repetitions, such as single leg squat, single leg deadlift, lateral step down, dan single leg calf raise.
| Study group | Role | What they receive |
|---|---|---|
| Low load-BFRt | Experimental | 70% of the arterial occlusion pressure and 30% of the maximum repetition rate Receives: Procedure: Low load-BFRt |
| Sham Low load-BFRt | Sham comparator | 10% of the arterial occlusion pressure and 30% of the maximum repetition rate Receives: Procedure: Sham Low load-BFRt |
| High load-Eccentric training | Active comparator | 70% of the maximum repetition rate Receives: Procedure: High load-Eccentric training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patella position
Using a musculoskeletal ultrasonography, researchers will determine the patella position.
Measured: 8 weeks
Muscle cross-sectional area
Using a musculoskeletal ultrasonography, researchers will determine the cross-sectional area of vastus medial obliques muscle and hamstring muscles.
Measured: 8 weeks
Vastus medial obliques fiber angle
Using a musculoskeletal ultrasonography, researchers will determine the vastus medial obliques fiber angle.
Measured: 8 weeks
Quadriceps strength
Using a hand-held dynamometer, researchers will determine the isometric quadriceps muscle.
Measured: 8 weeks
Dynamic balance
Using a modified star excursion balance test, researchers will determine the distance of three positions of legs reaching, including forward, posteromedial, and posterolateral.
Measured: 8 weeks
Leg function
Using KOOS questionnaires will determine the subjective score of the patient's leg function.
Measured: 8 weeks
Anterior knee pain
Using the Kujala questionnaire will determine the subjective score of the patient's knee pain levels.
Measured: 8 weeks
Secondary outcomes (1)
Incidence of anterior cruciate ligament reinjury
Researchers will determine the incidence of anterior cruciate ligament reinjury with the physical examination of Lachman's test.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion20 Nov 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Flow Restriction TrainingStudies 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
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I Putu Gde Surya Adhitya, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142889
- Sponsor's protocol ID
- 1937/UN14.2.2.VII.14/LT/2025
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Blood Flow Restriction Training on Patellar Position, Muscle Morphology, and Lower Limb Function in Patients After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT07142889
- Acronym / sponsor ID
- 1937/UN14.2.2.VII.14/LT/2025
- Conditions
- Blood Flow Restriction Training, Patella Position, Muscle Morphology, Anterior Cruciate Ligament Reconstruction, Leg Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 27 Aug 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.
This randomized clinical trial is designed to compare three different rehabilitation methods for patients who have undergone anterior cruciate ligament (ACL) reconstruction. The study aims to determine whether low-load blood flow restriction training (LL-BFRt) is more effective than high-load eccentric training (HL-Et) and a sham LL-BFRt in improving three key areas: patellar position, muscle morphology, and leg function.
Study Design and Interventions
Participants will be randomly assigned to one of the three intervention groups. All groups will perform eccentric exercises, including single leg squats, single leg deadlifts, lateral step downs, and single leg calf raises. The key differences lie in the load and the use of blood flow restriction:
LL-BFRt Group: Participants will train at 30% of their repetition maximum (RM) while a cuff restricts blood flow to 70% of their artery occlusion pressure (AOP).
HL-Et Group: Participants will train at a higher intensity, using 70% of their repetition maximum (RM), with no blood flow restriction.
Sham LL-BFRt Group: Participants will perform the same exercises as the LL-BFRt group at 30% of their RM, but the cuff will not be inflated to a pressure that restricts blood flow.
After the training period, the researchers will compare the outcomes across all three groups to see which method leads to the most significant improvements in patella position, muscle morphology, and leg function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low load-BFRt | Experimental | Procedure: Low load-BFRt70% of the arterial occlusion pressure and 30% of the maximum repetition rate |
| Sham Low load-BFRt | Sham comparator | Procedure: Sham Low load-BFRt10% of the arterial occlusion pressure and 30% of the maximum repetition rate |
| High load-Eccentric training | Active comparator | Procedure: High load-Eccentric training70% of the maximum repetition rate |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Ages 15-35 years old.
- History of a unilateral ACL injury, underwent ACL reconstruction surgery more than 6 months ago, and completed rehabilitation with physiotherapy.
- Adults participating in recreational or competitive sports at a minimum of level 3 on the Tegner Activity Scale.
- No prior history of a grade 3 sprain/strain injury to other tissues in the knee and foot.
- No recurring knee injuries after the ACL reconstruction surgery.
Key exclusion criteria (2 listed)
- Hypertension, circulatory disorders, sickle cell anemia, obesity, diabetes, kidney disorders, venous thromboembolism, cancer, and tumors are contraindications for BFR application.
- Experiencing a disability or being disabled.
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 |
|---|---|---|
| Low load-BFRtThe participants' two legs will be subjected to 70% arterial occlusion pressure when the physical therapist applies the BFR cuffs. After that, participants will be required to complete eccentric exercises with a maximum repetition count of 30%, such as single leg squat, single leg deadlift, lateral step down, dan single leg calf raise. | Procedure or surgery | Low load-BFRt |
| Sham Low load-BFRtThe participants' two legs will be subjected to 10% arterial occlusion pressure when the physical therapist applies the BFR cuffs. After that, participants will be required to complete eccentric exercises with a maximum repetition count of 30%, such as single leg squat, single leg deadlift, lateral step down, dan single leg calf raise. | Procedure or surgery | Sham Low load-BFRt |
| High load-Eccentric trainingThe physical therapist will instruct the participants to complete eccentric exercises at a maximum of 70% repetitions, such as single leg squat, single leg deadlift, lateral step down, dan single leg calf raise. | Procedure or surgery | High load-Eccentric training |
Primary outcome
Patella position
Time frame: 8 weeks
Using a musculoskeletal ultrasonography, researchers will determine the patella position.
Muscle cross-sectional area
Time frame: 8 weeks
Using a musculoskeletal ultrasonography, researchers will determine the cross-sectional area of vastus medial obliques muscle and hamstring muscles.
Vastus medial obliques fiber angle
Time frame: 8 weeks
Using a musculoskeletal ultrasonography, researchers will determine the vastus medial obliques fiber angle.
Quadriceps strength
Time frame: 8 weeks
Using a hand-held dynamometer, researchers will determine the isometric quadriceps muscle.
Dynamic balance
Time frame: 8 weeks
Using a modified star excursion balance test, researchers will determine the distance of three positions of legs reaching, including forward, posteromedial, and posterolateral.
Leg function
Time frame: 8 weeks
Using KOOS questionnaires will determine the subjective score of the patient's leg function.
Anterior knee pain
Time frame: 8 weeks
Using the Kujala questionnaire will determine the subjective score of the patient's knee pain levels.
1 secondary outcome
Incidence of anterior cruciate ligament reinjury
Time frame: 1 year
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 27 Aug 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low load-BFRt and High load-Eccentric training in people with Blood Flow Restriction Training and Patella Position, run by Udayana University at 1 site in Indonesia.
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 2 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 27 Aug 2025. 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 Indonesia. 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?
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 I Putu Gde Surya Adhitya (+6288975003567, surya_adhitya@unud.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patella position (time frame: 8 weeks). The study lists 7 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 27 Aug 2025.