Effects of Concurrent Aerobic and Resistance Training After Bariatric Surgery in Women: RCT (BARI-EX2023)

April 16, 2026 updated by: Mehmet GUNAY, Gazi University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06560
        • Gazi University, Faculty of Sport Sciences

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aerobic Training Group
Participants in this group perform 12 weeks of structured aerobic exercise for 3 sessions per week. Each session lasts approximately 45-60 minutes at a moderate intensity.
Behavioral: Aerobicexercise
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.
Experimental: Combined Training Group
Participants in this group perform 12 weeks of combined aerobic and resistance (strength) training for 3 sessions per week. The program includes both moderate-intensity aerobic exercise and resistance exercises targeting major muscle groups (2-3 sets of 8-12 repetitions).
Behavioral: Aerobicexercise
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.
Behavioral: Resistance Training
Supervised resistance training including 2-3 sets of 8-12 repetitions at 60-80% of 1RM targeting major muscle groups

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks
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).
Baseline and 12 weeks
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mehmet Günay, Prof.Dr., Gazi University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-1094
  • 24-AKD-95 (Other Identifier: Turkish Medicines and Medical Devices Agency ( T.İ.T.C.K))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared to protect participant privacy and maintain confidentiality, in accordance with the protocols approved by the Institutional Ethics Committee. Study results will be made available through peer-reviewed publications

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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