Clinical trial 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obese Patients
Overweight (BMI &gt; 25)
Keywords: Obesity
Blood Flow Restriction
Low Intensity Exercise
Antioxidant
Muscle Power
Cross Sectional Area
Hormone Profile
Overweight
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Istanbul University Research Fund
First posted: 2025-04-06
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in VO2Max
timeFrame: 6 weeks (pre-post test)
measure: Change in Isokinetic Muscle Strength
timeFrame: 6 weeks (pre-post test)
measure: Change in Muscle Cross-Sectional Area (CSA)
timeFrame: 6 weeks (pre-post test)
measure: Change in Muscle Thickness (MT)
timeFrame: 6 weeks (pre-post test)
Secondary outcomes:
measure: Change in Oxidative Stress and Antioxidant Capacity
timeFrame: 6 weeks
measure: Change in Cortisol Levels
timeFrame: 6 weeks
measure: Change in Glucose Levels
timeFrame: 6 weeks
measure: Change in Creatine Kinase Levels
timeFrame: 6 weeks
measure: Change in Cholesterol Levels
timeFrame: 6 weeks
measure: Change in Triglyceride Levels
timeFrame: 6 weeks
measure: Change in Testosterone Levels
timeFrame: 6 weeks
measure: Change in Luteinizing Hormone (LH) Levels
timeFrame: 6 weeks
measure: Change in Follicle-Stimulating Hormone (FSH) Levels
timeFrame: 6 weeks
measure: Change in Dehydroepiandrosterone Sulphate (DHEAS) Levels
timeFrame: 6 weeks
measure: Change in Sex Hormone-Binding Globulin (SHBG) Levels
timeFrame: 6 weeks
measure: Change in Free Androgen Index (FAI) Levels
timeFrame: 6 weeks
measure: Change in BMI (kg/m²)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Faculty of Medicine. Sports Medicine Department
Study officials:
References:
citation: Murakami K, Okimoto T, Kodama M, Tanahashi J, Yasaka S, Inoue K, Uchida M, Anan J, Mizukami K, Abe T, Watada M, Fujioka T. Helicobacter pylori and NSAID-induced gastric ulcer in a Japanese population. J Gastroenterol. 2009;44 Suppl 19:40-3. doi: 10.1007/s00535-008-2259-5. Epub 2009 Jan 16.
citation: Kim D, Singh H, Loenneke JP, Thiebaud RS, Fahs CA, Rossow LM, Young K, Seo DI, Bemben DA, Bemben MG. Comparative Effects of Vigorous-Intensity and Low-Intensity Blood Flow Restricted Cycle Training and Detraining on Muscle Mass, Strength, and Aerobic Capacity. J Strength Cond Res. 2016 May;30(5):1453-61. doi: 10.1519/JSC.0000000000001218.