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| ID | Type | Description | Link |
|---|---|---|---|
| 24-AKD-95 | Other Identifier | Turkish Medicines and Medical Devices Agency ( T.Ä°.T.C.K) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehmet Günay, Prof.Dr. | Gazi University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gazi University, Faculty of Sport Sciences | Ankara | Ankara | 06560 | Turkey (Türkiye) |
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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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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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
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| Resistance Training | Behavioral | Supervised resistance training including 2-3 sets of 8-12 repetitions at 60-80% of 1RM targeting major muscle groups |
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| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |