Clinical trial NCT06918314: "How Blood Flow Restriction Exercise Affects Muscle Oxygenation and Lactate in Elite Athletes"
Official title: The Effect of Blood Flow Restriction Exercise on Muscle Oxygenation and Lactate Levels in Elite Athletes: A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Flow Restriction Training
Muscle Oxygenation
Physiological Adaptations
Keywords: elite athletes
moxy
bfr
aerobic exercise
treadmill
Blood Lactate Levels
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 35
Sex: MALE
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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."
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in muscle oxygenation (SmO₂) measured by Moxy Muscle Oxygen Monitor (Near-Infrared Spectroscopy - NIRS)
timeFrame: Over a period of 2 months
measure: Change in blood lactate concentration measured by portable lactate analyzer (e.g., Lactate Scout+)
timeFrame: Immediately before and 3 minutes after each exercise session over a 2-month period
measure: Change in body fat percentage measured by Bioelectrical Impedance Analysis (TANITA BIA device)
timeFrame: Over a period of 2 months
measure: Change in muscle mass measured by Bioelectrical Impedance Analysis (TANITA BIA device)
timeFrame: Baseline and end of 2-month intervention
measure: Change in Body Mass Index (BMI) measured by Bioelectrical Impedance Analysis (TANITA BIA device)
timeFrame: Baseline and end of 2-month intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Burcin Ugur Tosun
Study officials:
affiliation: "Bandırma Onyedi Eylül University, Faculty of Health Sciences"
name: gulhan yılmaz gokmen, Assoc. Prof.
role: STUDY_DIRECTOR
References: