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.

NCT ID: NCT06912919

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2025-08-15

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.

Conditions

Obese Patients; Overweight (BMI > 25)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Blood Flow Restriction (BFR) Aerobic Exercise Group

6 weeks, 3 days a week, 20 minutes of cycling exercise using 160-180 mmHg BFR.

Group Type: EXPERIMENTAL

BFR-Aerobic Training

Intervention Type: OTHER

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

Control Group (No BFR)

6 weeks, 3 days a week, 20 minutes of cycling exercise, no BFR.

Group Type: EXPERIMENTAL

Aerobic Training Without BFR

Intervention Type: OTHER

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

Interventions

BFR-Aerobic Training

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

Intervention Type: OTHER

Aerobic Training Without BFR

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University Research Fund

UNKNOWN

Sponsor Role: collaborator

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Yasin Atay

Medical Doctor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul University Faculty of Medicine. Sports Medicine Department

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 19148792 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26439780 (View on PubMed)

Other Identifiers

YT-1

Identifier Type: -

Identifier Source: org_study_id