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Completed

NCT Number: NCT06918314

"How Blood Flow Restriction Exercise Affects Muscle Oxygenation and Lactate in Elite Athletes"

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.

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Key information

Conditions

Blood Flow Restriction Training Muscle Oxygenation Physiological Adaptations

Age range

15 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Burcin Ugur

Adana, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria:

Participants will be included or excluded based on the following conditions:

Inclusion criteria

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

Exclusion criteria

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

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

Treatment and study plan

Blood Flow Restriction Kaatsu Training Device

Device

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.

Other names: Moxy Muscle Oxygenation

Primary outcomes

  1. 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 (%)

  2. 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

  3. 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.

  4. 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)

  5. 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

Sponsors and collaborators

Lead sponsor

Eastern Mediterranean University

Other

Registry information

Official study title

The Effect of Blood Flow Restriction Exercise on Muscle Oxygenation and Lactate Levels in Elite Athletes: A Comparative Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 9, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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