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Completed

NCT Number: NCT06912919

Effects of Low-intensity Blood Flow Restriction Exercise on Aerobic Capacity, Muscle Strength, Muscle Size, Biochemical-hormonal Parameters and Antioxidant Parameters in Overweight and Obese Individuals.

Participants will be selected from sedentary men aged 18-30 and over with a body mass index of 25. First, an informed consent form will be signed by the individuals. The 'International Physical Activity Questionnaire' will be applied to the participants and it will be ensured that the participants have not participated in vigorous and moderate activities and therefore are inactive or minimally active individuals. The study will consist of an intervention group and a control group, and the groups will be randomized via computer. The exclusion criteria of the study are that the participants do not have any known cardiac or pulmonary pathology and do not have any musculoskeletal disorders that will affect their participation in exercise. First, blood samples will be taken from the participants. They will be sent to the laboratory for examination of biochemical, hormonal and antioxidant parameters. Then, the muscle cross-sectional area and muscle thickness values of the rectus femoris muscle will be calculated from the participants with ultrasound measurements. After these procedures are completed, Vo2Max calculation will be performed on the participants with a cardiopulmonary exercise test. In addition, 40% of the Vo2Max value calculated in this test will be calculated and the pulse range to be used in the exercise will be determined. In the final stage, participants' strength isokinetic test and knee flexion extension strength and endurance values will be calculated.

After the evaluations are completed, individuals will start a 6-week exercise program. The intervention group will exercise with the blood flow restriction method under 160 mmHg pressure for the first 3 weeks and 180 mmHg pressure for the last 3 weeks. The device will be applied by placing it at the most proximal point of the thigh. The control group will do the same exercise without restricting blood flow. Both groups will be followed for 6 weeks with a 5-minute warm-up followed by a 20-minute exercise program. Participants will report their fatigue with the Borg scale after each exercise session.

After the exercise sessions are completed, blood will be taken on an empty stomach within 24 hours of the last exercise. Then, muscle size measurement with ultrasound, Vo2Max calculation and isokinetic test power calculation will be noted, respectively. The values obtained will be compared with the initial values.

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Key information

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Faculty of Medicine. Sports Medicine Department

Istanbul, 34093, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Age: 18-30 Gender: Male Body Mass Index (BMI) ≥ 25 kg/m² Inactive or minimally active individuals (assessed with the International Physical Activity Questionnaire - IPAQ) No history of metabolic, cardiovascular or neuromuscular disease Not taking any medication that affects metabolism, hormones or muscle function Able to participate in a 6-week exercise program

Exclusion criteria

Having a cardiac or respiratory complaint Having a known chronic disease Having a medication used regularly

Treatment and study plan

BFR-Aerobic Training

Other

Low-intensity cycling exercise with BFR (pressure of 160-180 mmHg) for 20 minutes, 3 days a week for 6 weeks.

Aerobic Training Without BFR

Other

Low-intensity cycling exercise (without BFR) for 20 minutes, 3 days a week for 6 weeks.

Primary outcomes

  1. Change in VO2Max

    Time frame: 6 weeks (pre-post test)

    VO2Max (ml/kg/min) will be measured by indirect gas analysis and compared before and after exercise.

  2. Change in Isokinetic Muscle Strength

    Time frame: 6 weeks (pre-post test)

    Quadriceps and hamstring strength will be evaluated with an isokinetic dynamometer.

  3. Change in Muscle Cross-Sectional Area (CSA)

    Time frame: 6 weeks (pre-post test)

    The muscle cross-sectional area (cm²) of the Rectus Femoris will be measured by ultrasound (USG) and its change will be evaluated.

  4. Change in Muscle Thickness (MT)

    Time frame: 6 weeks (pre-post test)

    The muscle thickness (mm) of the Rectus Femoris will be measured by ultrasound (USG) and its change will be evaluated.

Secondary outcomes

  1. Change in Oxidative Stress and Antioxidant Capacity

    Time frame: 6 weeks

    Systemic oxidative stress and total antioxidant capacity will be assessed through blood biomarkers before and after the intervention.

  2. Change in Cortisol Levels

    Time frame: 6 weeks

    Cortisol levels will be measured with a pre- and post-exercise blood test.

  3. Change in Glucose Levels

    Time frame: 6 weeks

    Glucose levels will be measured with a pre- and post-exercise blood test.

  4. Change in Creatine Kinase Levels

    Time frame: 6 weeks

    Creatine kinase levels will be measured with a pre- and post-exercise blood test.

  5. Change in Cholesterol Levels

    Time frame: 6 weeks

    Cholesterol levels will be measured with a pre- and post-exercise blood test.

  6. Change in Triglyceride Levels

    Time frame: 6 weeks

    Triglyceride levels will be measured with a pre- and post-exercise blood test.

  7. Change in Testosterone Levels

    Time frame: 6 weeks

    Blood samples will be collected to measure testosterone levels before and after the intervention.

  8. Change in Luteinizing Hormone (LH) Levels

    Time frame: 6 weeks

    Luteinizing hormone (LH) levels will be measured with a pre- and post-exercise blood test.

  9. Change in Follicle-Stimulating Hormone (FSH) Levels

    Time frame: 6 weeks

    Follicle-stimulating hormone (FSH) levels will be measured with a pre- and post-exercise blood test.

  10. Change in Dehydroepiandrosterone Sulphate (DHEAS) Levels

    Time frame: 6 weeks

    Dehydroepiandrosterone sulphate (DHEAS) levels will be measured with a pre- and post-exercise blood test.

  11. Change in Sex Hormone-Binding Globulin (SHBG) Levels

    Time frame: 6 weeks

    Sex hormone-binding globulin (SHBG) levels will be measured with a pre- and post-exercise blood test.

  12. Change in Free Androgen Index (FAI) Levels

    Time frame: 6 weeks

    Free androgen index (FAI) levels will be measured with a pre- and post-exercise blood test.

  13. Change in BMI (kg/m²)

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

  • Istanbul University Research Fund

Registry information

Acronym: YT BFR

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 6, 2025
Registry last updated
Aug 20, 2025

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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