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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bariatric Surgery
- Sponsor
- Rio de Janeiro State University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Changes from baseline muscle strength at 6 months
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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).
Investigators
Luiz Guilherme Kraemer-Aguiar, MD
Professor
Rio de Janeiro State University
Eligibility Criteria
Inclusion Criteria
- •Patients subjected to Roux-en-Y gastric bypass
- •Aging 18 to 50-years
- •At least 12 months from surgery
- •Exclusion criteria:
- •Alcoholism
- •Gestation
- •Cardiovascular disease
- •Respiratory disease
- •Neurological disease
- •Infectious disease
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Changes from baseline muscle strength at 6 months
Time Frame: Baseline and 6 months of follow-up
Muscle strength will be evaluated by one repetition maximum test and handgrip strength
Changes from baseline bone microarchitecture at 6 months
Time Frame: Baseline and 6 months of follow-up
Bone microarchitecture will be assessed by High-resolution peripheral quantitative computed tomography
Changes from baseline blood biomarkers at 6 months
Time Frame: Baseline and 6 months of follow-up
Metabolic profile will be evaluated by blood sample collection
Changes from baseline body composition at 6 months
Time Frame: Baseline and 6 months of follow-up
Muscle mass and body mineral density will be assessed by Dual-energy X-ray Absortiometry
Secondary Outcomes
- Changes from baseline cardiovascular risk factors at 6 months(Baseline and 6 months of follow-up)
- Changes from baseline hemodynamic measurement at 6 months(Baseline and 6 months of follow-up)
- Changes from baseline endothelial function at 6 months(Baseline and 6 months of follow-up)
- Changes from baseline quality of life indicators at 6 months(Baseline and 6 months of follow-up)
- Changes from baseline anthropometric markers at 6 months(Baseline and 6 months of follow-up)