Healthy IndividualsNCT06746792
Low Load, High Gains: Blood Flow Restriction's Impact on Quadriceps Adaptations
A study testing Low-load resistance exercise with blood flow restriction and High-load resistance exercise in people with Healthy Individuals, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
Low-load resistance exercise with blood flow restriction (BFR-RE) presents a compelling alternative to high-load resistance exercise (HL-RE), particularly in scenarios where high loads are not feasible due to various limitations. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- Low-load resistance exercise with blood flow restriction and High-load resistance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Oct 2024to 29 Mar 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 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- keep healthy
- must be able to attend training regularly
Who cannot join
- smoking habit
- had orthopedic conditions that hindered lower-body resistance exercise, had hypertension (140/90 mm Hg), or had a BMI exceeding 30 kg/m2
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabuk University Faculty of Sports Sciences
Karabük, 78000
About this study
Low-load resistance exercise with blood flow restriction (BFR-RE) presents a compelling alternative to high-load resistance exercise (HL-RE), particularly in scenarios where high loads are not feasible due to various limitations. Blood flow restriction exercise restricts blood flow to the working muscle, creating a state of ischemia. A significant advantage of BFR-RE lies in its capacity to stimulate muscle hypertrophy and strength adaptations using light external loads (20-30% 1RM), comparable to those achieved with high-load (HL) training programs that employ 70-85% 1RM As a result, BFR training has been increasingly adopted in both athletic performance and rehabilitation settings over the past few decades. Quadriceps strength and power are essential factors in both the advancement of athletic performance and the successful return to unrestricted sporting activity following injury. The findings of Culvenor et al.'s review strongly suggest that weakened quadriceps strength is a significant risk factor for symptomatic and functional decline in the knee during both activities of daily living and sport-recreational activities. Numerous electromyographic (EMG) findings suggest that single-joint and multijoint exercises elicit varying muscle activation patterns. For instance, single-joint exercises targeting the quadriceps, such as leg extensions, demonstrate higher EMG amplitudes compared to multijoint lower-extremity exercises like leg presses and squats. Resistance training, characterized by the application of high mechanical tension, remains the cornerstone for promoting muscle hypertrophy, So, research suggests that higher training intensities are associated with greater hypertrophy, up to a certain point. While both light and heavy loads have been shown to elicit similar muscle growth when sets are taken to failure. Studies have reported that high-repetition training with light loads leads to greater central fatigue. Existing literature comparing the effects of BFR-RE and HL-RE primarily focuses on the some quadriceps and hamstring muscle group and its associated exercises. However, none of these studies employed a training protocol in which sets were taken to or near failure.
- Conditions
- Healthy Individuals
- Being tested
- Low-load resistance exercise with blood flow restriction, High-load resistance exercise
- Keywords
- vascular occlusion, shear wave elastography, hypertrophy, muscle stiffness, strength
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-load resistance exercise with blood flow restrictionOther
Also called (BFR-RE)
BFR-RE group performed bilateral leg extension exercises to volitional exhaustion (90 seconds rest between sets, 30% 1RM) with BFR cuffs applied at 60% of limb occlusion pressure.
High-load resistance exerciseOther
Also called (HL-RE)
The HL-RE group performed the same exercise to volitional exhaustion (90 seconds rest between sets, 70% 1RM) without BFR cuffs.
| Study group | Role | What they receive |
|---|---|---|
| Muscle thickness | Experimental | Muscular hypertrophy , or muscle growth, refers to an increase in muscle mass. There are two types of muscular hypertrophy: myofibrillar, which is an increase in myofibrils, and sarcoplasmic, which is an increase in muscle glycogen storage. Receives: Other: Low-load resistance exercise with blood flow restriction; Other: High-load resistance exercise |
| Muscle stiffness and strength | Experimental | Muscle and tendon stiffness is defined as an internal resistance to changes in muscle and tendon shape caused by an external force. Muscle strength production takes place with the help of the elastic behavior of the muscles and tendons Receives: Other: Low-load resistance exercise with blood flow restriction; Other: High-load resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thigh Circumference
Measurement of thigh circumference was performed at a point 33% distal to the inguinal crease, precisely matching the intended cuff application site as verified by a trained investigator. The inguinal crease-to-superior patellar pole distance was also recorded using a standard anthropometric tape measure
Measured: 2 day
Muscle Strength Test
Prior to commencing the strength assessment, using a Lafayette Manual Muscle Testing System (Lafayette Instrument Company, Lafayette®) a period of familiarization was allowed between the examiner and participant. Subsequently, a trained examiner guided the participant through a series of practice repetitions of leg flexion, and leg extension movements until correct execution was confirmed. The order of movements was randomized. The participant was then verbally instructed to perform three maximal contractions for each movement (3-second hold). A 1-minute rest interval was incorporated between successive contractions, and a 3-minute rest interval was implemented between different movement sets. Measurement of leg extension were obtained with participants in a seated position, while leg flexion measurement were taken with participants in a prone position.
Measured: 2 day
Muscle Thickness Assessment
Subjects had not engaged in physical activity before the study (48-72 hours), and muscle thickness (MT) was measured at a prone rest position. All muscle thickness measurements were obtained with a single ultrasound device equipped with a 2-9 MHz linear transducer. A researcher (medical doctor, N.K.K) who was blinded to the exercise groups with more than 10 years of experience in musculoskeletal imaging performed all measurement
Measured: 4 day
Muscle Stiffness and Shear Wave Elastography
After the muscle thickness measurements, the stiffness measurements of quadriceps muscle were obtained using the shear wave elastography (SWE) imaging option of the same ultrasound device with the same linear transducer.
Measured: 4 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start11 Oct 2024
- Primary completion29 Mar 2025 (estimated)
- Study completion29 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Şakir Akgül, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746792
- Sponsor's protocol ID
- KarabukUniSportsSciences
- Status last verified
- Mar 2025
- First submitted
- 11 Dec 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All antropometric and muscle strength, muscle thickness, and muscle stiffness parameters will be shared
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Load, High Gains: Blood Flow Restriction's Impact on Quadriceps Adaptations
- ClinicalTrials.gov ID
- NCT06746792
- Acronym / sponsor ID
- KarabukUniSportsSciences
- Conditions
- Healthy Individuals
- Keywords
- vascular occlusion, shear wave elastography, hypertrophy, muscle stiffness, strength
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 29 Mar 2025 (estimated)
- Study completion
- 29 Mar 2025 (estimated)
- First posted
- 24 Dec 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.
Low-load resistance exercise with blood flow restriction (BFR-RE) presents a compelling alternative to high-load resistance exercise (HL-RE), particularly in scenarios where high loads are not feasible due to various limitations. Blood flow restriction exercise restricts blood flow to the working muscle, creating a state of ischemia. A significant advantage of BFR-RE lies in its capacity to stimulate muscle hypertrophy and strength adaptations using light external loads (20-30% 1RM), comparable to those achieved with high-load (HL) training programs that employ 70-85% 1RM As a result, BFR training has been increasingly adopted in both athletic performance and rehabilitation settings over the past few decades. Quadriceps strength and power are essential factors in both the advancement of athletic performance and the successful return to unrestricted sporting activity following injury. The findings of Culvenor et al.'s review strongly suggest that weakened quadriceps strength is a significant risk factor for symptomatic and functional decline in the knee during both activities of daily living and sport-recreational activities. Numerous electromyographic (EMG) findings suggest that single-joint and multijoint exercises elicit varying muscle activation patterns. For instance, single-joint exercises targeting the quadriceps, such as leg extensions, demonstrate higher EMG amplitudes compared to multijoint lower-extremity exercises like leg presses and squats. Resistance training, characterized by the application of high mechanical tension, remains the cornerstone for promoting muscle hypertrophy, So, research suggests that higher training intensities are associated with greater hypertrophy, up to a certain point. While both light and heavy loads have been shown to elicit similar muscle growth when sets are taken to failure. Studies have reported that high-repetition training with light loads leads to greater central fatigue. Existing literature comparing the effects of BFR-RE and HL-RE primarily focuses on the some quadriceps and hamstring muscle group and its associated exercises. However, none of these studies employed a training protocol in which sets were taken to or near failure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle thickness | Experimental | Other: Low-load resistance exercise with blood flow restriction, Other: High-load resistance exerciseMuscular hypertrophy , or muscle growth, refers to an increase in muscle mass. There are two types of muscular hypertrophy: myofibrillar, which is an increase in myofibrils, and sarcoplasmic, which is an increase in muscle glycogen storage. |
| Muscle stiffness and strength | Experimental | Other: Low-load resistance exercise with blood flow restriction, Other: High-load resistance exerciseMuscle and tendon stiffness is defined as an internal resistance to changes in muscle and tendon shape caused by an external force. Muscle strength production takes place with the help of the elastic behavior of the muscles and tendons |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- keep healthy
- must be able to attend training regularly
Key exclusion criteria (2 listed)
- smoking habit
- had orthopedic conditions that hindered lower-body resistance exercise, had hypertension (140/90 mm Hg), or had a BMI exceeding 30 kg/m2
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 resistance exercise with blood flow restrictionAlso: (BFR-RE)BFR-RE group performed bilateral leg extension exercises to volitional exhaustion (90 seconds rest between sets, 30% 1RM) with BFR cuffs applied at 60% of limb occlusion pressure. | Other | Muscle stiffness and strength, Muscle thickness |
| High-load resistance exerciseAlso: (HL-RE)The HL-RE group performed the same exercise to volitional exhaustion (90 seconds rest between sets, 70% 1RM) without BFR cuffs. | Other | Muscle stiffness and strength, Muscle thickness |
Primary outcome
Thigh Circumference
Time frame: 2 day
Measurement of thigh circumference was performed at a point 33% distal to the inguinal crease, precisely matching the intended cuff application site as verified by a trained investigator. The inguinal crease-to-superior patellar pole distance was also recorded using a standard anthropometric tape measure
Muscle Strength Test
Time frame: 2 day
Prior to commencing the strength assessment, using a Lafayette Manual Muscle Testing System (Lafayette Instrument Company, Lafayette®) a period of familiarization was allowed between the examiner and participant. Subsequently, a trained examiner guided the participant through a series of practice repetitions of leg flexion, and leg extension movements until correct execution was confirmed. The order of movements was randomized. The participant was then verbally instructed to perform three maximal contractions for each movement (3-second hold). A 1-minute rest interval was incorporated between successive contractions, and a 3-minute rest interval was implemented between different movement sets. Measurement of leg extension were obtained with participants in a seated position, while leg flexion measurement were taken with participants in a prone position.
Muscle Thickness Assessment
Time frame: 4 day
Subjects had not engaged in physical activity before the study (48-72 hours), and muscle thickness (MT) was measured at a prone rest position. All muscle thickness measurements were obtained with a single ultrasound device equipped with a 2-9 MHz linear transducer. A researcher (medical doctor, N.K.K) who was blinded to the exercise groups with more than 10 years of experience in musculoskeletal imaging performed all measurement
Muscle Stiffness and Shear Wave Elastography
Time frame: 4 day
After the muscle thickness measurements, the stiffness measurements of quadriceps muscle were obtained using the shear wave elastography (SWE) imaging option of the same ultrasound device with the same linear transducer.
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 4 Mar 2025.
- Individual participant dataSharing planned: Yes. All antropometric and muscle strength, muscle thickness, and muscle stiffness parameters will be shared
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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. 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 resistance exercise with blood flow restriction and High-load resistance exercise in people with Healthy Individuals, run by Karabuk University at 1 site in Turkey (Türkiye).
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 2 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: under way, not looking for participants, as of the sponsor's last update on 4 Mar 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 Turkey (Türkiye). 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?
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?
Thigh Circumference (time frame: 2 day). The study lists 4 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 4 Mar 2025.