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The purpose of this clinical trial is to study the effects of resistance training program on physical-functional fitness, muscle mass and strength, endothelial function, blood pressure, biochemical markers of cardiovascular risk and bone metabolism, density and microstructure and quality of life of post-bariatric patients (Study 1). To compare the bone and muscle changes in post-bariatric patients by Roux-en-Y Gastric Bypass Surgery with non-bariatric controls, as well as to correlate these health indicators with surgery time and weight loss (Study 2).
Randomized controlled trial (Study 1) will feature post-bariatric patients in outpatient care at the public health unit. The post-bariatric patients will be randomized through a random code generator software (www.randomization.com) at a ratio of 1:1, into two groups: a) Intervention group - that will perform a supervised RT program for 6-months or b) Non-exercised control group - that will receive the standard clinical follow-up and shall not change their physical activity behavior. The exercise sessions will include: a) 10-min specific warm-up, consisting of one set of 20 repetitions with loads corresponding to 50% of the resistance used in the first exercise of the training session; b) 45-min of resistance exercises for the upper and lower body (8 single and multi-joint exercises with free weights and machines, including seated rowing, leg press, bench press, leg flexion, pull down, leg extension, shoulder press, and abdominal exercises), performed with 2-3 sets of 8 to 12 repetitions with loads ≥ 70% of one-repetition maximum (1RM) interspersed with 2 min intervals between sets; c) 5-min recovery with stretch and cool-down exercises. During six months, all training sessions will occur three times a week on nonconsecutive days. The outcomes will be assessed by dual energy X-ray emission densitometry (DXA); high resolution peripheral quantitative computed tomography (HR-pQCT), repetition maximum, handgrip strength; biochemical analysis (blood lipid profile, blood glucose and biomarkers of bone formation and absorption and calcium metabolism); venous occlusion plethysmography and nailfold videocapillaroscopy; blood pressure measurement and 36-Item Short-form Health Survey. The cross-sectional study (Study 2) will have 2 groups: post-bariatric patients group (BG) and control group (CG) - non-bariatric controls. Outcomes will be assessed by DXA; HR-pQCT; handgrip strength and biochemical analysis (blood lipid profile, blood glucose and biomarkers of bone formation and absorption and calcium metabolism).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise training | Experimental | Post-bariatric patients - Intervention group |
|
| No intervention | No Intervention | Post-bariatric patients - Non-exercised control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise training | Behavioral | Resistance training program performed during 6 months, 3 sessions per week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline body composition at 6 months | Muscle mass and body mineral density will be assessed by Dual-energy X-ray Absortiometry | Baseline and 6 months of follow-up |
| Changes from baseline bone microarchitecture at 6 months | Bone microarchitecture will be assessed by High-resolution peripheral quantitative computed tomography | Baseline and 6 months of follow-up |
| Changes from baseline muscle strength at 6 months | Muscle strength will be evaluated by one repetition maximum test and handgrip strength | Baseline and 6 months of follow-up |
| Changes from baseline blood biomarkers at 6 months | Bone formation and reabsorption biomarkers will be evaluated by blood sample collection | Baseline and 6 months of follow-up |
| Changes from baseline blood biomarkers at 6 months | Metabolic profile will be evaluated by blood sample collection | Baseline and 6 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline quality of life indicators at 6 months | Quality of life indicators will be evaluated by 36-Item Short-form Health Survey | Baseline and 6 months of follow-up |
| Changes from baseline cardiovascular risk factors at 6 months |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luiz Guilherme K De Aguiar, PhD | Rio de Janeiro State University, Rio de Janeiro, RJ, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University | Rio de Janeiro | Rio de Janeiro, Brazil | 20550013 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41703971 | Derived | de Almeida CM, Lopes KG, da Costa Tavares Bezerra M, Leal PRF, Bouskela E, da Gama EMF, de Farias MLF, Madeira M, Kraemer-Aguiar LG. Bone Health After Metabolic and Bariatric Surgery: Osteometabolism Biomarkers, Bone Mineral Density, and Microarchitecture. Obesity (Silver Spring). 2026 Mar;34(3):598-607. doi: 10.1002/oby.70132. Epub 2026 Feb 17. | |
| 36056396 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Intervention group will perform a supervised resistance training program, while non-exercised control group will receive the standard clinical follow-up and shall not change their physical activity behavior (Study 1) and Post-bariatric group or non-bariatric control group (Study 2)
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Cardiovascular risk factors will be evaluated by body mass index, waist circumference, blood pressure, triglycerides, HDL-c, LDL-c, total cholesterol, and fasting glycemia
| Baseline and 6 months of follow-up |
| Changes from baseline anthropometric markers at 6 months | Anthropometric markers will be determined by a digital scale and wall-mounted stadiometer | Baseline and 6 months of follow-up |
| Changes from baseline hemodynamic measurement at 6 months | Blood pressure and heart rate will be assessed by a digital sphygmomanometer | Baseline and 6 months of follow-up |
| Changes from baseline endothelial function at 6 months | Endothelial function will be evaluated by venous occlusion plethysmography and periungual videocapilaroscopy | Baseline and 6 months of follow-up |
| Lopes KG, das Gracas Coelho de Souza M, da Costa Tavares Bezerra M, Bessa LM, Farinatti P, Bouskela E, Madeira M, Kraemer-Aguiar LG. Effects of physical training on physical and functional fitness, physical activity level, endothelial function, hemodynamic variables, bone metabolism, and quality of life of post-bariatric patients: study protocol for a randomized controlled trial. Trials. 2022 Sep 2;23(1):733. doi: 10.1186/s13063-022-06677-z. |
| 35320489 | Derived | Lopes KG, Romagna EC, da Silva DS, da Costa Tavares Bezerra M, Leal PRF, da Silva Soares Pinto JE, Bouskela E, das Gracas Coelho de Souza M, Kraemer-Aguiar LG. Metabolic and Inflammatory Profiles of Post-Bariatric Patients with Weight Recidivism. Obes Surg. 2022 Jun;32(6):1849-1855. doi: 10.1007/s11695-022-06025-9. Epub 2022 Mar 23. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |