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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Changes from baseline muscle strength at 6 months
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients subjected to Roux-en-Y gastric bypass
- •Aging 18 to 50-years
- •At least 12 months from surgery
排除标准
- •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
结局指标
主要结局
Changes from baseline muscle strength at 6 months
时间窗: 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
时间窗: Baseline and 6 months of follow-up
Bone microarchitecture will be assessed by High-resolution peripheral quantitative computed tomography
Changes from baseline body composition at 6 months
时间窗: 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 blood biomarkers at 6 months
时间窗: Baseline and 6 months of follow-up
Bone formation and reabsorption biomarkers will be evaluated by blood sample collection
次要结局
- 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)
研究者
Luiz Guilherme Kraemer-Aguiar, MD
Professor
Rio de Janeiro State University
