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.

NCT06912919 | Completed

• 1 other identifier: YT-1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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)

Keywords

Obesity; Blood Flow Restriction; Low Intensity Exercise; Antioxidant; Muscle Power; Cross Sectional Area; Hormone Profile; Overweight

Outcome Measures

Primary Outcomes (4)

• Change in VO2Max

  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

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

  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.

  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.

  6 weeks (pre-post test)

Secondary Outcomes (13)

• Change in Oxidative Stress and Antioxidant Capacity

  6 weeks

• Change in Cortisol Levels

  6 weeks

• Change in Glucose Levels

  6 weeks

• Change in Creatine Kinase Levels

  6 weeks

• Change in Cholesterol Levels

  6 weeks

Study Arms (2)

Blood Flow Restriction (BFR) Aerobic Exercise Group

EXPERIMENTAL

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

Other: BFR-Aerobic Training

Control Group (No BFR)

EXPERIMENTAL

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

Other: Aerobic Training Without BFR

Interventions

BFR-Aerobic Training OTHER

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

Blood Flow Restriction (BFR) Aerobic Exercise Group

Aerobic Training Without BFR OTHER

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

Control Group (No BFR)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: For study symmetry, only male sedentary overweight and obese individuals were selected.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University: lead
• Istanbul University Research Fund: collaborator

Study Sites (1)

Istanbul University Faculty of Medicine. Sports Medicine Department

Istanbul, Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 19148792 BACKGROUND

• 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.

  PMID: 26439780 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: April 6, 2025
• Study Start: April 15, 2025
• Primary Completion: July 15, 2025
• Study Completion: August 15, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)