Blood Flow Restriction TrainingNCT06566950
BFR Training on Muscle Morphology
A study testing Low load-BFRt and High load-Eccentric training in people with Blood Flow Restriction Training and Eccentric Training, run by Udayana University at 1 site in Indonesia.
Trial summary
This randomized clinical trial study compares high-load eccentric training (HL-Et), sham LL-BFRt, and low-load blood flow restriction (LL-BFRt) in sportsmen. The primary inquiries it seeks to address are: Is LL-BFR superior to HL-Et and sham LL-BFRt in terms of improving muscle morphology? Is LL-BFR a more effective… Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Flow Restriction Training, Eccentric Training, 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
- 75 participants
- Where
- 1 siteIndonesia
- Study dates
- 20 Sep 2024to 20 Nov 2025
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Being between the ages of 15 and 35
- Play level 1 sports (fight martial arts, basketball, futsal, and soccer) at least twice a week
- Never experienced an Patellofemoral Pain Syndrome or ACL injury before
- Never experienced a grade III sprain or strain
- Consent to participate in the study until its conclusion and provide informed consent.
Who cannot join
- Having a tumor, cancer, vena thromboembolic disease, obesity, diabetes, hypertension, anemia, and renal failure
- Disabilities or those who are 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, 1 recruiting
- Recruiting
Physical therapy laboratory, College of Medicine, Universitas Udayana and ROM Physiotherapy Private Clinic Denpasar
Denpasar, Bali, 80232
I Putu Gde Surya Adhitya, PhD, +6288975003567, surya_adhitya@unud.ac.id
About this study
Official title: Effectiveness of Blood Flow Restriction Training on Muscle Morphology and Prevention of Patellofemoral Pain Syndrome and Anterior Cruciate Ligament Injury
This randomized clinical trial study compares high-load eccentric training (HL-Et), sham LL-BFRt, and low-load blood flow restriction (LL-BFRt) in sportsmen. The primary inquiries it seeks to address are:
Is LL-BFR superior to HL-Et and sham LL-BFRt in terms of improving muscle morphology? Is LL-BFR a more effective Patellofemoral Pain Syndrome and ACL injury preventive than HL-Et and sham LL-BFRt?
Read more
The three intervention groups that will be randomly assigned to participants are LL-BFRt, sham LL-BFRt, and HL-Et. Participants are expected to carry out:
Participants in LL-BFRt will be required to perform LL eccentric training at 30% of their repetition maximum (RM) and 70% of their artery occlusion pressure (AOP). This training will include stairs, single leg squat, and single leg deadlift.
Participants in HL-Et will be required to perform LL eccentric training at 70% of their maximum number of repetitions (RM).
In order to determine whether muscular morphology and the prevention of Patellofemoral Pain Syndrome and ACL injury improve following the interventions and follow-up, researchers will compare LL-BFRt, sham LL-BFRt, and HL-Et.
- Conditions
- Blood Flow Restriction Training, Eccentric Training, Muscle Morphology, Patellofemoral Pain Syndrome, Anterior Cruciate Ligament Injuries
- Being tested
- Low load-BFRt, Sham Low load-BFRt, High load-Eccentric training
- Medical subject headings
- Patellofemoral Pain Syndrome, Anterior Cruciate Ligament Injuries
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 stairs, single leg squat, and single leg deadlift.
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 stairs, single leg squat, and single leg deadlift.
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 stairs, single leg squat, and single leg deadlift.
| 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.
Muscle cross-sectional area
Using a musculoskeletal ultrasonography, researchers will determine the cross-sectional area of vastus medial obliques muscle and peroneus longus muscle.
Measured: 8 weeks
Vastus medial obliques fiber angle
Using a musculoskeletal ultrasonography, researchers will determine the vastus medial obliques fiber angle.
Measured: 8 weeks
Patella position
Using a musculoskeletal ultrasonography, researchers will determine the patella position.
Measured: 8 weeks
Secondary outcomes (2)
Incidence of patellofemoral pain syndrome
Researchers will determine the incidence of patellofemoral pain syndrome with the physical examination of grind test.
Measured: 1 year
Incidence of anterior cruciate ligament injury
Researchers will determine the incidence of anterior cruciate ligament injury 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 posted22 Aug 2024
- Study start20 Sep 2024
- Primary completion20 Nov 2024
- Study completion20 Nov 2025 (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
- 75 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
- NCT06566950
- Sponsor's protocol ID
- 1791/UN14.2.2.VII.14/LT.2024
- Status last verified
- Jun 2025
- First submitted
- 18 Aug 2024
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Blood Flow Restriction Training on Muscle Morphology and Prevention of Patellofemoral Pain Syndrome and Anterior Cruciate Ligament Injury
- ClinicalTrials.gov ID
- NCT06566950
- Acronym / sponsor ID
- 1791/UN14.2.2.VII.14/LT.2024
- Conditions
- Blood Flow Restriction Training, Eccentric Training, Muscle Morphology, Patellofemoral Pain Syndrome, Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 22 Aug 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 randomized clinical trial study compares high-load eccentric training (HL-Et), sham LL-BFRt, and low-load blood flow restriction (LL-BFRt) in sportsmen. The primary inquiries it seeks to address are:
Is LL-BFR superior to HL-Et and sham LL-BFRt in terms of improving muscle morphology? Is LL-BFR a more effective Patellofemoral Pain Syndrome and ACL injury preventive than HL-Et and sham LL-BFRt?
The three intervention groups that will be randomly assigned to participants are LL-BFRt, sham LL-BFRt, and HL-Et. Participants are expected to carry out:
Participants in LL-BFRt will be required to perform LL eccentric training at 30% of their repetition maximum (RM) and 70% of their artery occlusion pressure (AOP). This training will include stairs, single leg squat, and single leg deadlift.
Participants in HL-Et will be required to perform LL eccentric training at 70% of their maximum number of repetitions (RM).
In order to determine whether muscular morphology and the prevention of Patellofemoral Pain Syndrome and ACL injury improve following the interventions and follow-up, researchers will compare LL-BFRt, sham LL-BFRt, and HL-Et.
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
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Being between the ages of 15 and 35
- Play level 1 sports (fight martial arts, basketball, futsal, and soccer) at least twice a week
- Never experienced an Patellofemoral Pain Syndrome or ACL injury before
- Never experienced a grade III sprain or strain
- Consent to participate in the study until its conclusion and provide informed consent.
Key exclusion criteria (2 listed)
- Having a tumor, cancer, vena thromboembolic disease, obesity, diabetes, hypertension, anemia, and renal failure
- Disabilities or those who are 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 stairs, single leg squat, and single leg deadlift. | 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 stairs, single leg squat, and single leg deadlift. | 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 stairs, single leg squat, and single leg deadlift. | Procedure or surgery | High load-Eccentric training |
Primary outcome
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 peroneus longus muscle.
Vastus medial obliques fiber angle
Time frame: 8 weeks
Using a musculoskeletal ultrasonography, researchers will determine the vastus medial obliques fiber angle.
Patella position
Time frame: 8 weeks
Using a musculoskeletal ultrasonography, researchers will determine the patella position.
2 secondary outcomes
Incidence of patellofemoral pain syndrome
Time frame: 1 year
Incidence of anterior cruciate ligament injury
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 29 Jun 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 Eccentric Training, 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 5 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: looking for participants now, as of the sponsor's last update on 29 Jun 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, PhD (+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?
Muscle cross-sectional area (time frame: 8 weeks). The study lists 3 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 29 Jun 2025.