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Completed

NCT Number: NCT07537543

Effects of Concurrent Aerobic and Resistance Training After Bariatric Surgery in Women: RCT

The purpose of this study is to evaluate the effects of a 12-week exercise program on body composition and various physical and physiological parameters in patients who have undergone bariatric surgery. The exercise interventions include aerobic training and combined aerobic and resistance (strength) training. The study aims to determine the impact of these exercise approaches on post-operative recovery and overall physical fitness in this population.

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Key information

Conditions

Obesity &Amp; Overweight Bariatric Surgery Body Weight Exercise Adaptation Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University, Faculty of Sport Sciences

Ankara, 06560, Turkey (Türkiye)

About this study

Objectives and Methods: This study aimed to investigate the effects of a 12-week structured exercise program on body composition and selected physical and physiological parameters in female patients who had undergone bariatric surgery. A total of twenty women who had received sleeve gastrectomy and were in the early post-operative period (third month after surgery) were included in the study. Participants engaged in supervised exercise interventions consisting of aerobic training as well as combined aerobic and resistance (strength) training protocols, designed in accordance with standard exercise prescription principles. The exercise programs were implemented over a 12-week period with regular monitoring to ensure adherence and safety. Anthropometric measurements, including body weight, body mass index, and waist-to-hip ratio, were obtained using standardized procedures. Body composition parameters such as body fat percentage, regional fat distribution, lean body mass, and basal metabolic rate were assessed using appropriate measurement techniques. In addition, selected biochemical parameters, including markers related to metabolic health, were evaluated through blood analyses. All measurements were conducted at baseline and repeated at the end of the 12-week intervention period under consistent conditions to ensure reliability and comparability of the data.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18-65 years
  • Sleeve gastrectomy performed at least 3 months prior to enrollment
  • Medical clearance for participation in exercise
  • No history of lower extremity injury within the past year
  • Ability to perform cycling and running exercises

Exclusion criteria

  • Medical contraindications to exercise participation
  • Surgery performed more than 1 year prior to enrollment
  • Presence of neurological, hormonal, cardiovascular, or respiratory disorders within the past year
  • Lower extremity muscle or joint discomfort within the past 6 months
  • Voluntary withdrawal from the study
  • Occurrence of adverse events during the study
  • Failure to attend ≥2 consecutive sessions per week or ≥20% of total sessions during the 12-week intervention period
  • Exclusion due to non-adherence to the protocol (n=2), resulting in a final sample of 18 participants

Treatment and study plan

Aerobicexercise

Behavioral

The aerobic exercise intervention is a supervised 12-week program conducted 3 sessions per week. Each session lasts approximately 45-60 minutes and consists of: 1) A 5-10 minute warm-up period at low intensity, 2) 30-40 minutes of moderate-intensity aerobic activity (treadmill walking or stationary cycling) targeted at 60-70% of the heart rate reserve (HRR), and 3) A 5-10 minute cool-down period. Exercise intensity is continuously monitored using heart rate monitors to ensure compliance and adherence to the prescribed intensity zones.

Resistance training

Behavioral

Supervised resistance training including 2-3 sets of 8-12 repetitions at 60-80% of 1RM targeting major muscle groups

Primary outcomes

  1. Change in Body Mass Index (BMI)

    Time frame: Baseline and 12 weeks

    BMI is calculated as weight in kilograms divided by the square of height in meters (kg/m2). It is used to assess the change in body mass relative to height following the 12-week exercise intervention.

  2. Change in Body Lean Mass

    Time frame: Baseline and 12 weeks

    Total body lean mass (fat-free mass) measured in kilograms (kg) using Bioelectrical Impedance Analysis (BIA). This measure assesses the preservation of muscle tissue during weight loss following the 12-week exercise intervention.

  3. Change in Total Body Water

    Time frame: Baseline and 12 weeks

    Total amount of water in the body, measured in kilograms ($kg$) using Bioelectrical Impedance Analysis (BIA). It reflects changes in hydration status and lean tissue composition.

  4. Change in Basal Metabolic Rate (BMR)

    Time frame: Baseline and 12 weeks

    The amount of energy expended daily by the body at rest, measured in kilocalories (kcal) via BIA. This measure evaluates the metabolic efficiency following the intervention.

  5. Change in Metabolic Age

    Time frame: Baseline and 12 weeks

    A calculated value based on BIA parameters that compares an individual's BMR to the average BMR of their age group, measured in years (years).

  6. Change in Glycated Hemoglobin (HbA1c)

    Time frame: Baseline and 12 weeks

    Measurement of average blood glucose levels over the past 2-3 months, recorded as a percentage (%). Venous blood samples are analyzed to evaluate long-term glycemic control.

  7. Change in Serum C-Peptide Levels

    Time frame: Baseline and 12 weeks

    Measurement of C-peptide levels in the blood (ng/mL) as an indicator of endogenous insulin production and pancreatic beta-cell function.

  8. Change in Serum Uric Acid

    Time frame: Baseline and 12 weeks

    Measurement of uric acid concentration in the blood (mg/dL), used to monitor metabolic health and risk of hyperuricemia post-surgery.

  9. Change in Blood Urea Levels

    Time frame: Baseline and 12 weeks

    Measurement of urea concentration in the blood ($mg/dL$) to evaluate kidney function and protein metabolism during the intervention period.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

The Effects of Concurrent Aerobic and Resistance Training on Body Composition and Metabolic Parameters in Women Following Sleeve Gastrectomy: A Randomized Controlled Trial

Acronym: BARI-EX2023

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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