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

NCT07537543 | Completed

• 2 other identifiers: 2023-109424-AKD-95
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity &Amp; Overweight; Bariatric Surgery; Exercise Adaptation

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Aerobic Training Group

EXPERIMENTAL

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

Combined Training Group

EXPERIMENTAL

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; Behavioral: Resistance Training

Interventions

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.

Aerobic Training Group; Combined Training Group

Resistance Training BEHAVIORAL

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

Combined Training Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University, Faculty of Sport Sciences

Ankara, Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mehmet Günay, Prof.Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Model Details: 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

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 17, 2026
• Study Start: September 2, 2024
• Primary Completion: November 25, 2024
• Study Completion: December 2, 2024
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)