Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University
Rio de Janeiro, Rio de Janeiro, Brazil, 20550013, Brazil
NCT Number: NCT04193397
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).
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Rio de Janeiro, Rio de Janeiro, Brazil, 20550013, Brazil
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Resistance training program performed during 6 months, 3 sessions per week
Time frame: Baseline and 6 months of follow-up
Muscle mass and body mineral density will be assessed by Dual-energy X-ray Absortiometry
Time frame: Baseline and 6 months of follow-up
Bone microarchitecture will be assessed by High-resolution peripheral quantitative computed tomography
Time frame: Baseline and 6 months of follow-up
Muscle strength will be evaluated by one repetition maximum test and handgrip strength
Time frame: Baseline and 6 months of follow-up
Bone formation and reabsorption biomarkers will be evaluated by blood sample collection
Time frame: Baseline and 6 months of follow-up
Metabolic profile will be evaluated by blood sample collection
Time frame: Baseline and 6 months of follow-up
Quality of life indicators will be evaluated by 36-Item Short-form Health Survey
Time frame: 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
Time frame: Baseline and 6 months of follow-up
Anthropometric markers will be determined by a digital scale and wall-mounted stadiometer
Time frame: Baseline and 6 months of follow-up
Blood pressure and heart rate will be assessed by a digital sphygmomanometer
Time frame: Baseline and 6 months of follow-up
Endothelial function will be evaluated by venous occlusion plethysmography and periungual videocapilaroscopy
Rio de Janeiro State University
Other
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
Acronym: Obesity
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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