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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07537543
Acronym
BARI-EX2023
Enrollment
20
Registered
2026-04-17
Start date
2024-09-02
Completion date
2024-12-02
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Exercise Adaptation, Obesity &Amp; Overweight

Brief summary

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.

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.

Interventions

BEHAVIORALAerobicexercise

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.

BEHAVIORALResistance Training

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

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Intervention model description

A parallel-group randomized trial designed to compare the effects of two distinct 12-week exercise interventions. Participants are assigned to either a 12-week Aerobic Training group or a 12-week Combined Aerobic and Resistance Training group to evaluate changes in body composition and physiological parameters following bariatric surgery

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Body Mass Index (BMI)Baseline and 12 weeksBMI 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.
Change in Body Lean MassBaseline and 12 weeksTotal 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.
Change in Total Body WaterBaseline and 12 weeksTotal 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.
Change in Basal Metabolic Rate (BMR)Baseline and 12 weeksThe 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.
Change in Metabolic AgeBaseline and 12 weeksA calculated value based on BIA parameters that compares an individual's BMR to the average BMR of their age group, measured in years (years).
Change in Glycated Hemoglobin (HbA1c)Baseline and 12 weeksMeasurement 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.
Change in Serum C-Peptide LevelsBaseline and 12 weeksMeasurement of C-peptide levels in the blood (ng/mL) as an indicator of endogenous insulin production and pancreatic beta-cell function.
Change in Serum Uric AcidBaseline and 12 weeksMeasurement of uric acid concentration in the blood (mg/dL), used to monitor metabolic health and risk of hyperuricemia post-surgery.
Change in Blood Urea LevelsBaseline and 12 weeksMeasurement of urea concentration in the blood ($mg/dL$) to evaluate kidney function and protein metabolism during the intervention period.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORMehmet Günay, Prof.Dr.

Gazi University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026