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).
Study Type
INTERVENTIONAL
Resistance training program performed during 6 months, 3 sessions per week
Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University
Rio de Janeiro, Rio de Janeiro, Brazil, Brazil
Changes from baseline body composition at 6 months
Muscle mass and body mineral density will be assessed by Dual-energy X-ray Absortiometry
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 6 months of follow-up
Changes from baseline blood biomarkers at 6 months
Metabolic profile will be evaluated by blood sample collection
Time frame: Baseline and 6 months of follow-up
Changes from baseline quality of life indicators at 6 months
Quality of life indicators will be evaluated by 36-Item Short-form Health Survey
Time frame: Baseline and 6 months of follow-up
Changes from baseline cardiovascular risk factors at 6 months
Cardiovascular risk factors will be evaluated by body mass index, waist circumference, blood pressure, triglycerides, HDL-c, LDL-c, total cholesterol, and fasting glycemia
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 6 months of follow-up