Bariatric Surgery
Conditions
Keywords
Obesity, Muscle mass, Muscle strength, Bone mineral density, Bone microarchitecture
Brief summary
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).
Detailed description
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).
Interventions
BEHAVIORALExercise training
Resistance training program performed during 6 months, 3 sessions per week
Sponsors
Rio de Janeiro State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patients subjected to Roux-en-Y gastric bypass * Aging 18 to 50-years * At least 12 months from surgery
Exclusion criteria
* Smoking * Alcoholism * Gestation * Cardiovascular disease * Respiratory disease * Neurological disease * Infectious disease * Endocrine disease * Musculoskeletal impairments * Use of hormonal replacement therapy that influence bone metabolism * Use of medications that influence bone metabolism * Start some physical exercise program during the study * Excess weight loss \<50% * Use drugs that interfere with weight * Revisional bariatric surgery * Regular physical exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline body composition at 6 months | Baseline and 6 months of follow-up | Muscle mass and body mineral density will be assessed by Dual-energy X-ray Absortiometry |
| Changes from baseline bone microarchitecture at 6 months | Baseline and 6 months of follow-up | Bone microarchitecture will be assessed by High-resolution peripheral quantitative computed tomography |
| Changes from baseline muscle strength at 6 months | Baseline and 6 months of follow-up | Muscle strength will be evaluated by one repetition maximum test and handgrip strength |
| Changes from baseline blood biomarkers at 6 months | Baseline and 6 months of follow-up | Bone formation and reabsorption biomarkers will be evaluated by blood sample collection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline quality of life indicators at 6 months | Baseline and 6 months of follow-up | Quality of life indicators will be evaluated by 36-Item Short-form Health Survey |
| Changes from baseline endothelial function at 6 months | Baseline and 6 months of follow-up | Endothelial function will be evaluated by venous occlusion plethysmography and periungual videocapilaroscopy |
| Changes from baseline cardiovascular risk factors at 6 months | Baseline and 6 months of follow-up | Cardiovascular risk factors will be evaluated by body mass index, waist circumference, blood pressure, triglycerides, HDL-c, LDL-c, total cholesterol, and fasting glycemia |
| Changes from baseline anthropometric markers at 6 months | Baseline and 6 months of follow-up | Anthropometric markers will be determined by a digital scale and wall-mounted stadiometer |
| Changes from baseline hemodynamic measurement at 6 months | Baseline and 6 months of follow-up | Blood pressure and heart rate will be assessed by a digital sphygmomanometer |
Countries
Brazil
Outcome results
None listed