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

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: Completed
• Conditions: Bariatric Surgery; Obesity &Amp; Overweight; Exercise Adaptation
• Intervention / Treatment: Behavioral: Aerobicexercise; Behavioral: Resistance Training

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: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye), 06560
      • Gazi University, Faculty of Sport Sciences

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Body Mass Index (BMI)	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	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	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)	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	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)	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	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	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	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

• Sponsor: Gazi University
• Investigators: Principal Investigator: Mehmet Günay, Prof.Dr., Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2024
• Primary Completion (Actual): November 25, 2024
• Study Completion (Actual): December 2, 2024

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Resistance Training
• Other Study ID 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