Healthy SubjectsNCT05951036
Effect of Blood Flow Restriction Training to Muscle Strength, Dynamic Stability, and ACL Injury Prevention
A study testing Low-load Blood Flow Restriction training and High-load Eccentric training in people with Healthy Subjects and Sports Level 1, run by Udayana University at 1 site in Indonesia.
Trial summary
The goal of this randomized clinical trial study is to compare low-load blood flow restriction (LL-BFRt), sham LL-BFRt, and high-load eccentric training (HL-Et) in healthy level 1 sportsman. The main questions it aims to answer are: 1. Does LL-BFR improve muscle strength better than sham LL-BFRt and HL-Et? 2. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Sports Level 1
- What is being tested?
- Low-load Blood Flow Restriction training 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
- 17 Jul 2023to 30 Nov 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 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Being 15-35 years old
- Perform sports level 1 (soccer, basket ball, futsal, combat martial art) at least twice per week.
- Never had an history of ACL injury
- Never had an history of sprain or strain grade III
- Agree to participate until the end of this study period and sign the inform consent
Who cannot join
- Having hypertension, blood circulation disease, anemia, obesity, diabetes, kidney failure, vena thromboembolic, cancer, and tumor.
- Disabilities or disabled people.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Physical therapy laboratory, College of Medicine, Universitas Udayana and ROM Physiotherapy Private Clinic Denpasar
Denpasar, Bali, 80232
About this study
Official title: Effects of Additional Blood Flow Restriction and Sham Blood Flow Restriction in Eccentric Exercise on Muscle Strength, Dynamic Stability, and Reduce the Risk of ACL Injury
The goal of this randomized clinical trial study is to compare low-load blood flow restriction (LL-BFRt), sham LL-BFRt, and high-load eccentric training (HL-Et) in healthy level 1 sportsman. The main questions it aims to answer are:
- Does LL-BFR improve muscle strength better than sham LL-BFRt and HL-Et?
- Does LL-BFR improve dynamic stability better than sham LL-BFRt and HL-Et?
- Does LL-BFR prevent ACL injury better than sham LL-BFRt and HL-Et?
Read more
Participants will be randomized into three intervention groups: LL-BFRt, sham LL-BFRt, and HL-Et. Participants will be asked to do:
- In LL-BFRt, participants will be asked to do LL eccentric training (including double leg squats, split squats, deadlifts, and monster walks) with a 30% of repetition maximum (RM) and 70% of arterial occlusion pressure (AOP).
- In sham LL-BFRt, participants will be asked to do LL eccentric training with a 30% of repetition maximum (RM) and 10% of arterial occlusion pressure (AOP).
- In HL-Et, participants will be asked to do LL eccentric training with a 70% of repetition maximum (RM).
Researchers will compare LL-BFRt, sham LL-BFRt, and HL-Et to see if muscle strength, dynamic stability, and ACL injury prevention improve after the interventions and follow-up.
Read the detailed description
Participants will be asked to do five sets of ten repetitions of each eccentric training, one-minute rest interval for each eccentric training and two mins rest interval between each set.
- Conditions
- Healthy Subjects, Sports Level 1
- Being tested
- Low-load Blood Flow Restriction training, Sham Low-load Blood Flow Restriction training, High-load Eccentric training
- Keywords
- blood flow restriction training, sham blood flow restriction training, BFR, Eccentric training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-load Blood Flow Restriction trainingProcedure or surgery
Physical therapist will apply the BFR cuffs with 70% of arterial occlusion pressure on the both legs of participants. Then, participants will be asked to perform eccentric trainings (including, double leg squats, split squats, deadlifts, and monster walks) with 30% of repetition maximum.
Sham Low-load Blood Flow Restriction trainingProcedure or surgery
Physical therapist will apply the BFR cuffs with 10% of arterial occlusion pressure on the both legs of participants. Then, participants will be asked to perform eccentric trainings (including, double leg squats, split squats, deadlifts, and monster walks) with 30% of repetition maximum.
High-load Eccentric trainingProcedure or surgery
Physical therapist will ask participants to perform eccentric trainings (including, double leg squats, split squats, deadlifts, and monster walks) with 70% of repetition maximum.
| Study group | Role | What they receive |
|---|---|---|
| LL-BFRt | Experimental | 30% of repetition maximum and 70% of arterial occlusion pressure Receives: Procedure: Low-load Blood Flow Restriction training |
| Sham LL-BFRt | Sham comparator | 30% of repetition maximum and 10% of arterial occlusion pressure Receives: Procedure: Sham Low-load Blood Flow Restriction training |
| HL-Et | Active comparator | 70% of repetition maximum Receives: Procedure: High-load Eccentric training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Investigators will measure the quadriceps muscle isometric strength using dynamometer (units: Newton or kilogram).
Measured: 8 weeks
Dynamic stability I
Investigators will measure the dynamic stability I using Y-balance test (units: centimeter).
Measured: 8 weeks
Dynamic stability II
Investigators will measure the dynamic stability II using single leg hop test (units: centimeter).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start17 Jul 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 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 Healthy SubjectsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
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
- NCT05951036
- Sponsor's protocol ID
- 1575/UN14.2.2.VII.14/LT/2023
- Status last verified
- Jun 2025
- First submitted
- 2 Jul 2023
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Adhitya IPGS, Aryana IGNW, Kurniawati I, Thanaya SAP, Utama MBR. Effect of Low-Load Blood Flow Restriction Training and High-Load Resistance Training on Quadriceps Strength, Dynamic Stability, and Functional Performance. Clin J Sport Med. 2026 Mar 1;36(2):111-119. doi: 10.1097/JSM.0000000000001330. Epub 2025 Feb 11.
PubMed 39932234
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
- Effects of Additional Blood Flow Restriction and Sham Blood Flow Restriction in Eccentric Exercise on Muscle Strength, Dynamic Stability, and Reduce the Risk of ACL Injury
- ClinicalTrials.gov ID
- NCT05951036
- Acronym / sponsor ID
- 1575/UN14.2.2.VII.14/LT/2023
- Conditions
- Healthy Subjects, Sports Level 1
- Keywords
- blood flow restriction training, sham blood flow restriction training, BFR, Eccentric training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 18 Jul 2023 (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.
The goal of this randomized clinical trial study is to compare low-load blood flow restriction (LL-BFRt), sham LL-BFRt, and high-load eccentric training (HL-Et) in healthy level 1 sportsman. The main questions it aims to answer are:
- Does LL-BFR improve muscle strength better than sham LL-BFRt and HL-Et?
- Does LL-BFR improve dynamic stability better than sham LL-BFRt and HL-Et?
- Does LL-BFR prevent ACL injury better than sham LL-BFRt and HL-Et?
Participants will be randomized into three intervention groups: LL-BFRt, sham LL-BFRt, and HL-Et. Participants will be asked to do:
- In LL-BFRt, participants will be asked to do LL eccentric training (including double leg squats, split squats, deadlifts, and monster walks) with a 30% of repetition maximum (RM) and 70% of arterial occlusion pressure (AOP).
- In sham LL-BFRt, participants will be asked to do LL eccentric training with a 30% of repetition maximum (RM) and 10% of arterial occlusion pressure (AOP).
- In HL-Et, participants will be asked to do LL eccentric training with a 70% of repetition maximum (RM).
Researchers will compare LL-BFRt, sham LL-BFRt, and HL-Et to see if muscle strength, dynamic stability, and ACL injury prevention improve after the interventions and follow-up.
Detailed description
Participants will be asked to do five sets of ten repetitions of each eccentric training, one-minute rest interval for each eccentric training and two mins rest interval between each set.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LL-BFRt | Experimental | Procedure: Low-load Blood Flow Restriction training30% of repetition maximum and 70% of arterial occlusion pressure |
| Sham LL-BFRt | Sham comparator | Procedure: Sham Low-load Blood Flow Restriction training30% of repetition maximum and 10% of arterial occlusion pressure |
| HL-Et | Active comparator | Procedure: High-load Eccentric training70% of repetition maximum |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Being 15-35 years old
- Perform sports level 1 (soccer, basket ball, futsal, combat martial art) at least twice per week.
- Never had an history of ACL injury
- Never had an history of sprain or strain grade III
- Agree to participate until the end of this study period and sign the inform consent
Key exclusion criteria (2 listed)
- Having hypertension, blood circulation disease, anemia, obesity, diabetes, kidney failure, vena thromboembolic, cancer, and tumor.
- Disabilities or disabled people.
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 Blood Flow Restriction trainingPhysical therapist will apply the BFR cuffs with 70% of arterial occlusion pressure on the both legs of participants. Then, participants will be asked to perform eccentric trainings (including, double leg squats, split squats, deadlifts, and monster walks) with 30% of repetition maximum. | Procedure or surgery | LL-BFRt |
| Sham Low-load Blood Flow Restriction trainingPhysical therapist will apply the BFR cuffs with 10% of arterial occlusion pressure on the both legs of participants. Then, participants will be asked to perform eccentric trainings (including, double leg squats, split squats, deadlifts, and monster walks) with 30% of repetition maximum. | Procedure or surgery | Sham LL-BFRt |
| High-load Eccentric trainingPhysical therapist will ask participants to perform eccentric trainings (including, double leg squats, split squats, deadlifts, and monster walks) with 70% of repetition maximum. | Procedure or surgery | HL-Et |
Primary outcome
Muscle strength
Time frame: 8 weeks
Investigators will measure the quadriceps muscle isometric strength using dynamometer (units: Newton or kilogram).
Dynamic stability I
Time frame: 8 weeks
Investigators will measure the dynamic stability I using Y-balance test (units: centimeter).
Dynamic stability II
Time frame: 8 weeks
Investigators will measure the dynamic stability II using single leg hop test (units: centimeter).
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 29 Jun 2025.
- Derived from this study: PubMed 39932234Adhitya IPGS, Aryana IGNW, Kurniawati I, Thanaya SAP, Utama MBR. Effect of Low-Load Blood Flow Restriction Training and High-Load Resistance Training on Quadriceps Strength, Dynamic Stability, and Functional Performance. Clin J Sport Med. 2026 Mar 1;36(2):111-119. doi: 10.1097/JSM.0000000000001330. Epub 2025 Feb 11.
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Blood Flow Restriction training and High-load Eccentric training in people with Healthy Subjects and Sports Level 1, 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: finished, 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?
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?
Muscle strength (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?
On the ClinicalTrials.gov record for NCT05951036, 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 29 Jun 2025.