Blood Flow Restriction TrainingNCT06918314
"How Blood Flow Restriction Exercise Affects Muscle Oxygenation and Lactate in Elite Athletes"
A study testing Blood Flow Restriction Kaatsu Training Device in people with Blood Flow Restriction Training and Muscle Oxygenation, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effects of blood flow restriction (BFR) training combined with low-intensity aerobic exercise on muscle oxygenation, total hemoglobin (THb), and blood lactate levels in elite athletes, comparing them with healthy sedentary individuals. Read more about this study
- Who is it for?
- Ages 15 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Flow Restriction Training, Muscle Oxygenation, Physiological Adaptations
- What is being tested?
- Blood Flow Restriction Kaatsu Training Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 19 Mar 2025
- 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 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Willingness to participate in the study
- Male individuals aged 15-18 years
- Sedentary status for control group participants (<600 MET-min/week according to the International Physical Activity Questionnaire - Short Form)
- Body mass index (BMI) <25 kg/m²
- Licensed track and field athlete for the study group
- At least 3 years of experience as a licensed sprint athlete
- No history of sports injury in the last 6 months
Who cannot join
- Presence of open wounds or infection in the lower extremities
- Leg pain, varicose veins, or thrombophlebitis
- Diabetes or a history of cardiovascular disease
- Smoking and/or alcohol consumption
- Presence of respiratory distress
- Bilateral lower extremity pain and edema
Show all 12Show fewer
- Incompatibility with the blood flow restriction (BFR) device
- Presence of diseases causing endothelial dysfunction (e.g., hypertension, cardiovascular diseases, neurological disorders, systemic inflammation, obesity, diabetes, atherosclerosis)
- History of deep vein thrombosis (DVT) or peripheral vascular disease
- Presence of acute infection
- History of cancer
- Surgical operation due to trauma within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Blood Flow Restriction Exercise on Muscle Oxygenation and Lactate Levels in Elite Athletes: A Comparative Study
This study investigates the effects of blood flow restriction (BFR) training combined with low-intensity aerobic exercise on muscle oxygenation, total hemoglobin (THb), and blood lactate levels in elite athletes, comparing them with healthy sedentary individuals. BFR training, which partially restricts arterial and fully restricts venous blood flow using a pneumatic cuff, creates a hypoxic environment, leading to muscle strength and endurance improvements with lower-intensity exercise. The study aims to determine whether BFR-induced occlusion enhances muscle adaptation and how these physiological responses differ between elite athletes and sedentary individuals.
Read the detailed description
This comparative cross-sectional study aims to examine the acute physiological responses to low-intensity aerobic exercise combined with blood flow restriction (BFR) training in elite male track and field athletes versus sedentary individuals. The primary focus is on changes in muscle oxygenation, total hemoglobin (THb), and blood lactate concentrations.
BFR is applied via a pneumatic cuff that partially restricts arterial and fully restricts venous return, thereby creating a localized hypoxic environment. This method has been shown to induce strength and endurance adaptations comparable to high-intensity training, even when performed at low intensities.
Near-infrared spectroscopy (NIRS) via the Moxy Muscle Oxygen Monitor will be used to assess muscle oxygenation parameters in real-time. Blood lactate levels will be measured through capillary sampling before and after exercise. Additional physiological parameters including heart rate, blood pressure, and respiratory rate will also be monitored.
The study compares two groups with distinct physical activity backgrounds, intending to elucidate potential differences in physiological adaptation to BFR. All measurements will be carried out in a controlled lab environment using validated instruments. Statistical analyses will be performed using SPSS software, with appropriate parametric or non-parametric methods depending on data distribution.
The results may contribute to a deeper understanding of BFR training mechanisms and guide tailored conditioning strategies for both athletic and sedentary populations.
- Being tested
- Blood Flow Restriction Kaatsu Training Device
- Keywords
- elite athletes, moxy, bfr, aerobic exercise, treadmill, Blood Lactate Levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction Kaatsu Training DeviceDevice
Also called Moxy Muscle Oxygenation
The Blood Flow Restriction (BFR) intervention uses a pneumatic cuff to partially restrict arterial and fully restrict venous blood flow, creating a hypoxic environment that enhances muscle activation and strength at low exercise intensities. In this study, BFR will be applied intermittently during low-intensity treadmill walking with controlled pressure adjustments.
The Moxy Muscle Oxygen Monitor is a non-invasive NIRS device that measures muscle oxygen saturation (SmO₂) and total hemoglobin (THb). Placed on the quadriceps femoris muscle, it will track oxygenation changes before, during, and after BFR exercise, helping assess muscle metabolism and performance adaptations.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Elite Male Athletes | Experimental | These participants are physically inactive or engage in minimal physical activity. They do not follow a structured exercise regimen and have no history of professional or competitive sports participation. They are in good general health, with no chronic diseases or musculoskeletal disorders that could affect the study outcomes. Receives: Device: Blood Flow Restriction Kaatsu Training Device |
| Healthy Sedentary Male Individuals | Active comparator | These participants are actively involved in elite-level athletics, following a structured and high-intensity training program. They have extensive experience in competitive sports, particularly in track and field disciplines. They are in optimal physical condition, with well-developed cardiovascular and musculoskeletal systems, and no history of major injuries or health conditions that could impact their performance. Receives: Device: Blood Flow Restriction Kaatsu Training Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle oxygenation (SmO₂) measured by Moxy Muscle Oxygen Monitor (Near-Infrared Spectroscopy - NIRS)
Muscle oxygenation (SmO₂) will be assessed using the Moxy Muscle Oxygen Monitor, a validated NIRS-based device placed on the vastus lateralis muscle. Measurements will be taken pre- and post-exercise across multiple sessions to observe acute and cumulative responses.Unit of Measure: Percentage (%)
Measured: Over a period of 2 months
Change in blood lactate concentration measured by portable lactate analyzer (e.g., Lactate Scout+)
Capillary blood samples will be collected from the fingertip immediately before and 3 minutes after low-intensity aerobic exercise. Lactate levels will be analyzed using a validated point-of-care lactate analyzer to assess the metabolic response to BFR training.Unit of Measure: mmol/L
Measured: Immediately before and 3 minutes after each exercise session over a 2-month period
Change in body fat percentage measured by Bioelectrical Impedance Analysis (TANITA BIA device)
Body fat percentage will be assessed using a validated TANITA BIA device to evaluate changes in body composition.
Measured: Over a period of 2 months
Change in muscle mass measured by Bioelectrical Impedance Analysis (TANITA BIA device)
Muscle mass will be assessed using a TANITA BIA device to track training-induced adaptations. Unit of Measure: Kilograms (kg)
Measured: Baseline and end of 2-month intervention
Change in Body Mass Index (BMI) measured by Bioelectrical Impedance Analysis (TANITA BIA device)
BMI will be calculated from height and weight data provided by the TANITA BIA device to observe general body composition trends. Unit of Measure: kg/m²
Measured: Baseline and end of 2-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Jul 2024
- Primary completion15 Oct 2024
- Study completion19 Mar 2025
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- "This study aims to compare two distinct groups: healthy sedentary male individuals and healthy elite male athletes. The research will focus on various physiological and performance-related parameters to examine the differences between these groups in terms of muscle function, cardiovascular efficiency, metabolic responses, and overall physical fitness. By analyzing these factors, the study seeks to provide valuable insights into the impact of regular high-intensity training on physical health and performance, as well as how a sedentary lifestyle affects these parameters. The findings may contribute to a better understanding of training adaptations and the physiological characteristics distinguishing elite athletes from their sedentary counterparts."
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin Uğur Tosun, Eastern Mediterranean University
- Investigators
- gulhan yılmaz gokmen, Assoc. Prof., Study director, "Bandırma Onyedi Eylül University, Faculty of Health Sciences"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918314
- Sponsor's protocol ID
- 2024-177
- Status last verified
- Jul 2026
- First submitted
- 12 Mar 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Flow Restriction Exercise on Muscle Oxygenation and Lactate Levels in Elite Athletes: A Comparative Study
- ClinicalTrials.gov ID
- NCT06918314
- Acronym / sponsor ID
- 2024-177
- Keywords
- elite athletes, moxy, bfr, aerobic exercise, treadmill, Blood Lactate Levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 9 Apr 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 study investigates the effects of blood flow restriction (BFR) training combined with low-intensity aerobic exercise on muscle oxygenation, total hemoglobin (THb), and blood lactate levels in elite athletes, comparing them with healthy sedentary individuals. BFR training, which partially restricts arterial and fully restricts venous blood flow using a pneumatic cuff, creates a hypoxic environment, leading to muscle strength and endurance improvements with lower-intensity exercise. The study aims to determine whether BFR-induced occlusion enhances muscle adaptation and how these physiological responses differ between elite athletes and sedentary individuals.
Detailed description
This comparative cross-sectional study aims to examine the acute physiological responses to low-intensity aerobic exercise combined with blood flow restriction (BFR) training in elite male track and field athletes versus sedentary individuals. The primary focus is on changes in muscle oxygenation, total hemoglobin (THb), and blood lactate concentrations.
BFR is applied via a pneumatic cuff that partially restricts arterial and fully restricts venous return, thereby creating a localized hypoxic environment. This method has been shown to induce strength and endurance adaptations comparable to high-intensity training, even when performed at low intensities.
Near-infrared spectroscopy (NIRS) via the Moxy Muscle Oxygen Monitor will be used to assess muscle oxygenation parameters in real-time. Blood lactate levels will be measured through capillary sampling before and after exercise. Additional physiological parameters including heart rate, blood pressure, and respiratory rate will also be monitored.
The study compares two groups with distinct physical activity backgrounds, intending to elucidate potential differences in physiological adaptation to BFR. All measurements will be carried out in a controlled lab environment using validated instruments. Statistical analyses will be performed using SPSS software, with appropriate parametric or non-parametric methods depending on data distribution.
The results may contribute to a deeper understanding of BFR training mechanisms and guide tailored conditioning strategies for both athletic and sedentary populations.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- "This study aims to compare two distinct groups: healthy sedentary male individuals and healthy elite male athletes. The research will focus on various physiological and performance-related parameters to examine the differences between these groups in terms of muscle function, cardiovascular efficiency, metabolic responses, and overall physical fitness. By analyzing these factors, the study seeks to provide valuable insights into the impact of regular high-intensity training on physical health and performance, as well as how a sedentary lifestyle affects these parameters. The findings may contribute to a better understanding of training adaptations and the physiological characteristics distinguishing elite athletes from their sedentary counterparts."
| Arm | Type | Receives |
|---|---|---|
| Healthy Elite Male Athletes | Experimental | Device: Blood Flow Restriction Kaatsu Training DeviceThese participants are physically inactive or engage in minimal physical activity. They do not follow a structured exercise regimen and have no history of professional or competitive sports participation. They are in good general health, with no chronic diseases or musculoskeletal disorders that could affect the study outcomes. |
| Healthy Sedentary Male Individuals | Active comparator | Device: Blood Flow Restriction Kaatsu Training DeviceThese participants are actively involved in elite-level athletics, following a structured and high-intensity training program. They have extensive experience in competitive sports, particularly in track and field disciplines. They are in optimal physical condition, with well-developed cardiovascular and musculoskeletal systems, and no history of major injuries or health conditions that could impact their performance. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Willingness to participate in the study
- Male individuals aged 15-18 years
- Sedentary status for control group participants (<600 MET-min/week according to the International Physical Activity Questionnaire - Short Form)
- Body mass index (BMI) <25 kg/m²
- Licensed track and field athlete for the study group
Key exclusion criteria (12 listed)
- Presence of open wounds or infection in the lower extremities
- Leg pain, varicose veins, or thrombophlebitis
- Diabetes or a history of cardiovascular disease
- Smoking and/or alcohol consumption
- Presence of respiratory distress
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 Kaatsu Training DeviceAlso: Moxy Muscle OxygenationThe Blood Flow Restriction (BFR) intervention uses a pneumatic cuff to partially restrict arterial and fully restrict venous blood flow, creating a hypoxic environment that enhances muscle activation and strength at low exercise intensities. In this study, BFR will be applied intermittently during low-intensity treadmill walking with controlled pressure adjustments. The Moxy Muscle Oxygen Monitor is a non-invasive NIRS device that measures muscle oxygen saturation (SmO₂) and total hemoglobin (THb). Placed on the quadriceps femoris muscle, it will track oxygenation changes before, during, and after BFR exercise, helping assess muscle metabolism and performance adaptations. | Device | Healthy Elite Male Athletes, Healthy Sedentary Male Individuals |
Primary outcome
Change in muscle oxygenation (SmO₂) measured by Moxy Muscle Oxygen Monitor (Near-Infrared Spectroscopy - NIRS)
Time frame: Over a period of 2 months
Muscle oxygenation (SmO₂) will be assessed using the Moxy Muscle Oxygen Monitor, a validated NIRS-based device placed on the vastus lateralis muscle. Measurements will be taken pre- and post-exercise across multiple sessions to observe acute and cumulative responses.Unit of Measure: Percentage (%)
Change in blood lactate concentration measured by portable lactate analyzer (e.g., Lactate Scout+)
Time frame: Immediately before and 3 minutes after each exercise session over a 2-month period
Capillary blood samples will be collected from the fingertip immediately before and 3 minutes after low-intensity aerobic exercise. Lactate levels will be analyzed using a validated point-of-care lactate analyzer to assess the metabolic response to BFR training.Unit of Measure: mmol/L
Change in body fat percentage measured by Bioelectrical Impedance Analysis (TANITA BIA device)
Time frame: Over a period of 2 months
Body fat percentage will be assessed using a validated TANITA BIA device to evaluate changes in body composition.
Change in muscle mass measured by Bioelectrical Impedance Analysis (TANITA BIA device)
Time frame: Baseline and end of 2-month intervention
Muscle mass will be assessed using a TANITA BIA device to track training-induced adaptations. Unit of Measure: Kilograms (kg)
Change in Body Mass Index (BMI) measured by Bioelectrical Impedance Analysis (TANITA BIA device)
Time frame: Baseline and end of 2-month intervention
BMI will be calculated from height and weight data provided by the TANITA BIA device to observe general body composition trends. Unit of Measure: kg/m²
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 20 Jul 2026.
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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.
gulhan yılmaz gokmen, Assoc. Prof. study director
"Bandırma Onyedi Eylül University, Faculty of Health Sciences"
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 Kaatsu Training Device in people with Blood Flow Restriction Training and Muscle Oxygenation, run by Eastern Mediterranean 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 7 inclusion and 12 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 20 Jul 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 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?
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?
Change in muscle oxygenation (SmO₂) measured by Moxy Muscle Oxygen Monitor (Near-Infrared Spectroscopy - NIRS) (time frame: Over a period of 2 months). The study lists 5 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 20 Jul 2026.