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. (YT BFR)

August 19, 2025 updated by: Yasin Atay, Istanbul University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34093
        • Istanbul University Faculty of Medicine. Sports Medicine Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood Flow Restriction (BFR) Aerobic Exercise Group
6 weeks, 3 days a week, 20 minutes of cycling exercise using 160-180 mmHg BFR.
Other: BFR-Aerobic Training
Low-intensity cycling exercise with BFR (pressure of 160-180 mmHg) for 20 minutes, 3 days a week for 6 weeks.
Experimental: Control Group (No BFR)
6 weeks, 3 days a week, 20 minutes of cycling exercise, no BFR.
Other: Aerobic Training Without BFR
Low-intensity cycling exercise (without BFR) for 20 minutes, 3 days a week for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks (pre-post test)
Change in Isokinetic Muscle Strength
Time Frame: 6 weeks (pre-post test)
Quadriceps and hamstring strength will be evaluated with an isokinetic dynamometer.
6 weeks (pre-post test)
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.
6 weeks (pre-post test)
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.
6 weeks (pre-post test)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
Change in Cortisol Levels
Time Frame: 6 weeks
Cortisol levels will be measured with a pre- and post-exercise blood test.
6 weeks
Change in Glucose Levels
Time Frame: 6 weeks
Glucose levels will be measured with a pre- and post-exercise blood test.
6 weeks
Change in Creatine Kinase Levels
Time Frame: 6 weeks
Creatine kinase levels will be measured with a pre- and post-exercise blood test.
6 weeks
Change in Cholesterol Levels
Time Frame: 6 weeks
Cholesterol levels will be measured with a pre- and post-exercise blood test.
6 weeks
Change in Triglyceride Levels
Time Frame: 6 weeks
Triglyceride levels will be measured with a pre- and post-exercise blood test.
6 weeks
Change in Testosterone Levels
Time Frame: 6 weeks
Blood samples will be collected to measure testosterone levels before and after the intervention.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
Change in BMI (kg/m²)
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Collaborators

Istanbul University Research Fund

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Actual)

July 15, 2025

Study Completion (Actual)

August 15, 2025

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 29, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

August 20, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YT-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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