Obesity &Amp; OverweightBARI-EX2023NCT07537543
Effects of Concurrent Aerobic and Resistance Training After Bariatric Surgery in Women: RCT
A study testing Aerobicexercise and Resistance Training in people with Obesity &Amp; Overweight and Bariatric Surgery, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obesity &Amp; Overweight, Bariatric Surgery, Exercise Adaptation
- What is being tested?
- Aerobicexercise and Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2024to 2 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Faculty of Sport Sciences
Ankara, Ankara, 06560
About this study
Official title: 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.
Read the 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.
- Being tested
- Aerobicexercise, Resistance Training
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AerobicexerciseBehavioural
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 TrainingBehavioural
Supervised resistance training including 2-3 sets of 8-12 repetitions at 60-80% of 1RM targeting major muscle groups
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Aerobicexercise; Behavioral: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start2 Sep 2024
- Primary completion25 Nov 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity &Amp; OverweightStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet GUNAY, Gazi University
- Investigators
- Mehmet Günay, Prof.Dr., Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537543
- Sponsor's protocol ID
- 2023-1094
- Other IDs
- 24-AKD-95
- Acronym
- BARI-EX2023
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Concurrent Aerobic and Resistance Training on Body Composition and Metabolic Parameters in Women Following Sleeve Gastrectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07537543
- Acronym / sponsor ID
- BARI-EX2023 / 2023-1094
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Aerobic Training Group | Experimental | Behavioral: AerobicexerciseParticipants 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. |
| Combined Training Group | Experimental | Behavioral: Aerobicexercise, Behavioral: Resistance TrainingParticipants 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AerobicexerciseThe 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. | Behavioural | Aerobic Training Group, Combined Training Group |
| Resistance TrainingSupervised resistance training including 2-3 sets of 8-12 repetitions at 60-80% of 1RM targeting major muscle groups | Behavioural | Combined Training Group |
Primary outcome
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.
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.
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.
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.
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).
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Günay, Prof.Dr. principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobicexercise and Resistance Training in people with Obesity &Amp; Overweight and Bariatric Surgery, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI) (time frame: Baseline and 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.