Effects of Physical Training on Health Markers of Post-bariatric Patients

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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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: a Randomized Controlled Trial

Conditions
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Bariatric Surgery

Intervention / Treatment
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* Behavioral: Exercise training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training<br>Post-bariatric patients - Intervention group | Behavioral: Exercise training<br>* Resistance training program performed during 6 months, 3 sessions per week<br>|
| No Intervention: No intervention<br>Post-bariatric patients - Non-exercised control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Muscle mass, Muscle strength, Bone mineral density, Bone microarchitecture