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临床试验/NCT04193397
NCT04193397已完成不适用

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

Rio de Janeiro State University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年12月1日最近更新:
适应症

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

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

发起方
Rio de Janeiro State University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luiz Guilherme Kraemer-Aguiar, MD

Professor

Rio de Janeiro State University

研究点 (2)

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