- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06918314
"How Blood Flow Restriction Exercise Affects Muscle Oxygenation and Lactate in Elite Athletes"
The Effect of Blood Flow Restriction Exercise on Muscle Oxygenation and Lactate Levels in Elite Athletes: A Comparative Study
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Famagusta, Cyprus, 99010
- Burcin Ugur Tosun
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Healthy Elite Male Athletes
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.
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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:
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Active Comparator: Healthy Sedentary Male Individuals
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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in muscle oxygenation (SmO₂) measured by Moxy Muscle Oxygen Monitor (Near-Infrared Spectroscopy - NIRS)
Time Frame: Over a period of 2 months
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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 (%)
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Over a period of 2 months
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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
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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
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Immediately before and 3 minutes after each exercise session over a 2-month period
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Change in body fat percentage measured by Bioelectrical Impedance Analysis (TANITA BIA device)
Time Frame: Over a period of 2 months
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Body fat percentage will be assessed using a validated TANITA BIA device to evaluate changes in body composition.
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Over a period of 2 months
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Change in muscle mass measured by Bioelectrical Impedance Analysis (TANITA BIA device)
Time Frame: Baseline and end of 2-month intervention
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Muscle mass will be assessed using a TANITA BIA device to track training-induced adaptations.
Unit of Measure: Kilograms (kg)
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Baseline and end of 2-month intervention
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Change in Body Mass Index (BMI) measured by Bioelectrical Impedance Analysis (TANITA BIA device)
Time Frame: Baseline and end of 2-month intervention
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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
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Baseline and end of 2-month intervention
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: gulhan yılmaz gokmen, Assoc. Prof., "Bandırma Onyedi Eylül University, Faculty of Health Sciences"
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024-177
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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