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临床试验/NCT04932642
NCT04932642已完成不适用

The Effects of Two Different Orders of Concurrent Training on the Interindividual Variability of Health Markers of Metabolic Syndrome and Fitness in Severe/Morbidly Obesity Women. A Randomized Control Trial

Cristian Alvarez2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2019年3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
43
试验地点
2
主要终点
Waist circumference

研究概览

简要总结

Concurrent training (CT, characterised by the inclusion of two exercise modalities), is recognised to improve metabolic syndrome (MetS) markers, but little is known about order session effect on interindividual variability. The purpose of the present study was to describe the effects, and the interindividual variability, of 20 weeks of CT in different order at (i.e., high intensity interval training (HIIT) plus resistance training (RT), compared with another group doing RT plus HIIT) in women with severe/morbidly obesity at risk of MetS.

详细描述

Morbid obesity, defined as a body mass index (BMI) of 40 kg/m2 (class III obesity), is a chronic disease with life-threatening cardiometabolic consequences such as elevated blood pressure (systolic [SBP] or diastolic BP [DBP]), fasting plasma glucose (FPG), triglycerides (Tg), and low high-density lipoprotein cholesterol (HDL-c), all summarised as metabolic syndrome (MetS). In this sense, exercise training as resistance training (RT), defined as any exercise that causes voluntary skeletal muscle contraction by using external weights such as dumbbells and metal bars, is a known non-pharmacotherapy strategy for improving muscle strength and functional capacity in obese patients undergoing bariatric surgery. Similarly, high-intensity interval training (HIIT), defined as several and brief bouts of high-intensity effort usually by cycling/running, interspersed by recovery periods ), has produced strong evidence for the improvement of cardiometabolic risk factors for type 2 diabetes mellitus, arterial hypertension, central arterial stiffness and, vascular function, and cardiorespiratory fitness. Thus, in individuals with morbid obesity, for example, exercise training has proven to be effective for inducing clinically significant weight loss (5-10%), and for the reduction of cardiovascular risk, following the standard recommendations for these cohorts prior to bariatric surgical. However, some inconsistencies have been described after CT, which are directly concerned with the 'order' (i.e. starting the CT session with MICT followed by RT, or vice versa) of the CT session. However, little is known about the interindividual variability of exercise training (IVET) in relation to different order sessions of CT in morbidly obese populations and health-related outcomes, such as MetS markers. Briefly, IVET means that some subjects achieve benefits after training, and are termed responders (Rs), while others exhibit a worsened or unchanged response, and that is commonly known termed as nonresponders (NRs).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

According to availability and the feasibility of the enrolment's requirements, patients will be allocated to aHIIT+RT group with morbid obesity, or to another exercise group of RT+HIIT with morbid obesity.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • being a candidate for bariatric surgery
  • aged between 18 and 60 years
  • tobe medically authorised
  • with a body mass index (BMI) ≥40 kg/m2 or ≥35 kg/m2
  • with additional comorbidities (i.e. diabetes, hypertension, insulin resistance) controlled by pharmacotherapy

排除标准

  • having physical limitations preventing the performance of exercise (e.g. restricting injuries of the musculoskeletal system)
  • having exercise-related dyspnoea or respiratory alterations
  • having chronic heart disease with any worsening in the last month
  • adhering to less than 80% of the total interventions (these results were excluded from the statistical analyses)

结局指标

主要结局

Waist circumference

时间窗: Baseline to 20-weeks of concurrent training

Component of metabolic syndrome risk factors

Diastolic blood pressure

时间窗: Baseline to 20-weeks of concurrent training

Component of metabolic syndrome risk factors

Systolic blood pressure

时间窗: Component of metabolic syndrome risk factors

Component of metabolic syndrome risk factors

Triglycerides

时间窗: Baseline to 20-weeks of concurrent training

Component of metabolic syndrome risk factors

Fasting glucose

时间窗: Baseline to 20-weeks of concurrent training

Component of metabolic syndrome risk factors

High-density lipoprotein cholesterol

时间窗: Baseline to 20-weeks of concurrent training

Component of metabolic syndrome risk factors

次要结局

  • Body fat percentage (%)(Baseline to 20-weeks of concurrent training)
  • Total cholesterol(Baseline to 20-weeks of concurrent training)
  • Skeletal muscle mass (kg)(Baseline to 20-weeks of concurrent training)
  • Body mass index (height/m2)(Baseline to 20-weeks of concurrent training)
  • Body mass (kg)(Baseline to 20-weeks of concurrent training)
  • Low-density lipoprotein cholesterol(Baseline to 20-weeks of concurrent training)
  • Lean mass (kg)(Baseline to 20-weeks of concurrent training)
  • Body fat (kilograms)(Baseline to 20-weeks of concurrent training)
  • Handgrip muscle strength (kg)(Baseline to 20-weeks of concurrent training)
  • Six minutes walking test(Baseline to 20-weeks of concurrent training)

研究者

发起方
Cristian Alvarez
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cristian Alvarez

Associate Professor

Universidad de Los Lagos

研究点 (2)

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