An interventional study of BFR-Aerobic Training and Aerobic Training Without BFR in Obese Patients and Overweight (BMI > 25), sponsored by Istanbul University. Completed at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by Istanbul University · Not applicable, Interventional, and Supportive care
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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This study's enrollment of 34 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
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Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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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
6 weeks, 3 days a week, 20 minutes of cycling exercise using 160-180 mmHg BFR.
Other: BFR-Aerobic Training
6 weeks, 3 days a week, 20 minutes of cycling exercise, no BFR.
Other: Aerobic Training Without BFR
Low-intensity cycling exercise with BFR (pressure of 160-180 mmHg) for 20 minutes, 3 days a week for 6 weeks.
Low-intensity cycling exercise (without BFR) for 20 minutes, 3 days a week for 6 weeks.
Change in VO2Max
VO2Max (ml/kg/min) will be measured by indirect gas analysis and compared before and after exercise.
Time frame: 6 weeks (pre-post test)
Change in Isokinetic Muscle Strength
Quadriceps and hamstring strength will be evaluated with an isokinetic dynamometer.
Time frame: 6 weeks (pre-post test)
Change in Muscle Cross-Sectional Area (CSA)
The muscle cross-sectional area (cm²) of the Rectus Femoris will be measured by ultrasound (USG) and its change will be evaluated.
Time frame: 6 weeks (pre-post test)
Change in Muscle Thickness (MT)
The muscle thickness (mm) of the Rectus Femoris will be measured by ultrasound (USG) and its change will be evaluated.
Time frame: 6 weeks (pre-post test)
Change in Oxidative Stress and Antioxidant Capacity
Systemic oxidative stress and total antioxidant capacity will be assessed through blood biomarkers before and after the intervention.
Time frame: 6 weeks
Change in Cortisol Levels
Cortisol levels will be measured with a pre- and post-exercise blood test.
Time frame: 6 weeks
Change in Glucose Levels
Glucose levels will be measured with a pre- and post-exercise blood test.
Time frame: 6 weeks
Change in Creatine Kinase Levels
Creatine kinase levels will be measured with a pre- and post-exercise blood test.
Time frame: 6 weeks
Change in Cholesterol Levels
Cholesterol levels will be measured with a pre- and post-exercise blood test.
Time frame: 6 weeks
Change in Triglyceride Levels
Triglyceride levels will be measured with a pre- and post-exercise blood test.
Time frame: 6 weeks
Change in Testosterone Levels
Blood samples will be collected to measure testosterone levels before and after the intervention.
Time frame: 6 weeks
Change in Luteinizing Hormone (LH) Levels
Luteinizing hormone (LH) levels will be measured with a pre- and post-exercise blood test.
Time frame: 6 weeks
Change in Follicle-Stimulating Hormone (FSH) Levels
Follicle-stimulating hormone (FSH) levels will be measured with a pre- and post-exercise blood test.
Time frame: 6 weeks
Change in Dehydroepiandrosterone Sulphate (DHEAS) Levels
Dehydroepiandrosterone sulphate (DHEAS) levels will be measured with a pre- and post-exercise blood test.
Time frame: 6 weeks
Change in Sex Hormone-Binding Globulin (SHBG) Levels
Sex hormone-binding globulin (SHBG) levels will be measured with a pre- and post-exercise blood test.
Time frame: 6 weeks
Change in Free Androgen Index (FAI) Levels
Free androgen index (FAI) levels will be measured with a pre- and post-exercise blood test.
Time frame: 6 weeks
Change in BMI (kg/m²)
Time frame: 6 weeks
Plan to share: No
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Istanbul University