AzTrials
AzTrials

Obese PatientsYT BFRNCT06912919

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.

A study testing BFR-Aerobic Training and Aerobic Training Without BFR in people with Obese Patients and Overweight (BMI > 25), run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for
Obese Patients, Overweight (BMI > 25)
What is being tested?
BFR-Aerobic Training and Aerobic Training Without BFR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Apr 2025to 15 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul University Faculty of Medicine. Sports Medicine Department

    Istanbul, Istanbul, 34093

Other trials in Turkey (Türkiye)

About this study

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.

Being tested
BFR-Aerobic Training, Aerobic Training Without BFR
Keywords
Obesity, Blood Flow Restriction, Low Intensity Exercise, Antioxidant, Muscle Power, Cross Sectional Area, Hormone Profile, Overweight
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BFR-Aerobic TrainingOther

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

  • Aerobic Training Without BFROther

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

Study groups in NCT06912919
Study groupRoleWhat they receive
Blood Flow Restriction (BFR) Aerobic Exercise GroupExperimental6 weeks, 3 days a week, 20 minutes of cycling exercise using 160-180 mmHg BFR.
Receives: Other: BFR-Aerobic Training
Control Group (No BFR)Experimental6 weeks, 3 days a week, 20 minutes of cycling exercise, no BFR.
Receives: Other: Aerobic Training Without BFR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in VO2Max

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

    Measured: 6 weeks (pre-post test)

  2. Change in Isokinetic Muscle Strength

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

    Measured: 6 weeks (pre-post test)

  3. 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.

    Measured: 6 weeks (pre-post test)

  4. 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.

    Measured: 6 weeks (pre-post test)

Secondary outcomes (13)

  1. 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.

    Measured: 6 weeks

  2. Change in Cortisol Levels

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

    Measured: 6 weeks

  3. Change in Glucose Levels

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

    Measured: 6 weeks

  4. Change in Creatine Kinase Levels

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

    Measured: 6 weeks

  5. Change in Cholesterol Levels

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

    Measured: 6 weeks

  6. Change in Triglyceride Levels

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

    Measured: 6 weeks

  7. Change in Testosterone Levels

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

    Measured: 6 weeks

  8. Change in Luteinizing Hormone (LH) Levels

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

    Measured: 6 weeks

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

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

    Measured: 6 weeks

  10. Change in Dehydroepiandrosterone Sulphate (DHEAS) Levels

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

    Measured: 6 weeks

  11. 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.

    Measured: 6 weeks

  12. Change in Free Androgen Index (FAI) Levels

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

    Measured: 6 weeks

  13. Change in BMI (kg/m²)

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2025
  2. Study start15 Apr 2025
  3. Primary completion15 Jul 2025
  4. Study completion15 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06912919
Sponsor's protocol ID
YT-1
Acronym
YT BFR
Status last verified
Jan 2025
First submitted
13 Mar 2025
Last updated
20 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19148792

  • 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.

    PubMed 26439780

Questions about this trial

What is this clinical trial studying?

A study testing BFR-Aerobic Training and Aerobic Training Without BFR in people with Obese Patients and Overweight (BMI > 25), run by Istanbul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in VO2Max (time frame: 6 weeks (pre-post test)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06912919, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.

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