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

NCT06918314 | Completed

• 1 other identifier: 2024-177
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Blood Flow Restriction Training; Muscle Oxygenation; Physiological Adaptations

Keywords

elite athletes; moxy; bfr; aerobic exercise; treadmill; Blood Lactate Levels

Outcome Measures

Primary Outcomes (5)

• 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 (%)

  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

  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.

  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)

  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

  Baseline and end of 2-month intervention

Study Arms (2)

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.

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.

Device: Blood Flow Restriction Kaatsu Training Device

Interventions

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.

Also known as: Moxy Muscle Oxygenation

Healthy Elite Male Athletes; Healthy Sedentary Male Individuals

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Burcin Ugur Tosun

Famagusta, 99010, Cyprus

Location

Study Officials

• gulhan yılmaz gokmen, Assoc. Prof.

  "Bandırma Onyedi Eylül University, Faculty of Health Sciences"

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Healthy Sedentary Male Individuals: 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. Healthy Elite Male Athletes: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator PhD Physiotherapist Burcin Ugur Tosun

Model Details: "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."

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 9, 2025
• Study Start: May 1, 2024
• Primary Completion: October 15, 2024
• Study Completion: March 19, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

CY (1)