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临床试验/NCT03003754
NCT03003754已完成不适用

Supervised Exercise-training in Children With Insulin Resistance or Healthy Metabolic Profile: Cardiometabolic Risk Factors and Muscular Strength Changes in Responders and Non Responders

Universidad Santo Tomas1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change from Baseline in plasma homeostasis model assessment (HOMA-IR)

研究概览

简要总结

Despite exercise training decrease blood fasting glycemia in 'average' terms, there is a wide interindividual variability after exercise training explored mainly in adults but not in children. Thus, is yet unknown what baseline health status as well as the influence of what health variable may produce more/less non-responder (NR) prevalence (i.e., percentage of subjects who experienced a non-change/worsened response after training in some metabolic outcomes) after exercise training in school children.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
9 Years 至 13 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Diagnosed of insulin resistance by one of three plasmatic glucose control: HOMA-IR ≥3.0,
  • •Fasting insulin levels ≥15 µUI/dL or fasting glucose ≥100 and ≤126 mg/dL within the enrolment stage applied at school (i.e., ≤3 months),
  • •Physical inactivity (volume of ≤60 min/day of moderate physical activity),
  • •To be participating of regular practical physical education classes at school (i.e., 90 min/week),
  • •Living only in urban areas.

排除标准

  • •Potential medical, musculoskeletal problems or a familial history of T2DM,
  • •Ischemic disease,
  • •Arrhythmia,
  • •Utilization of drugs that modulate the metabolic and respiratory control.

研究组 & 干预措施

High Intensity Training (HIT) + Resistance Training (RT)

Experimental

To HIT program will be use cycle ergometers adapted for children (OXFORDTM, model BE2601, OXOFORD Inc, Santiago, Chile) were used. Each participant performed a range of 8 to 14 cycling intervals during the intervention period. The time of each work interval cycling will be increased progressively weekly, and ranged between 40-60 s (40 s weeks 1-2; 50 s weeks 3-5; 60 s week 6), with 120 s of passive rest (over the bicycle without movement) between each interval of work.

The RT will consist in voluntary concentric/eccentric exercise during 1 minute until to get a high subjective effort perception (i.e., between 8-10 points based on the modified and subjective Borg scale of 1 to 10 points. Subjects will perform 4 exercises (biceps curl, leg-extension, shoulders press, and upper row exercise) during 6-weeks.

干预措施: High Intensity Training (HIT) + Resistance Training (RT) (Behavioral)

Control group

Active Comparator

We will compare within each group (G)-1, G-2, and G-3 sub-group according to both RT and HIT intervention both pre-post changes as well as if are there some anthropometric, cardiovascular, and performance variable predicting changes in homeostasis model assessment (HOMA-IR).

干预措施: Control group (Behavioral)

结局指标

主要结局

Change from Baseline in plasma homeostasis model assessment (HOMA-IR)

时间窗: Baseline and 6 weeks immediately after the interventions ends

次要结局

  • Change from Baseline in one maximum repetition strength test of shoulder press exercise(Baseline and 6 weeks immediately after the interventions ends)
  • Change from Baseline in fat mass(Baseline and 6 weeks immediately after the interventions ends)
  • Change from Baseline in fasting glucose(Baseline and 6 weeks immediately after the interventions ends)
  • Change from Baseline in body mass(Baseline and 6 weeks immediately after the interventions ends)
  • Change from Baseline in one maximum repetition strength test of leg-extension exercise(Baseline and 6 weeks immediately after the interventions ends)
  • Change from Baseline in blood pressure(Baseline and 6 weeks immediately after the interventions ends)
  • Change from Baseline in one maximum repetition strength test of upper-row exercise(Baseline and 6 weeks immediately after the interventions ends)
  • Change from Baseline in body mass index(Baseline and 6 weeks immediately after the interventions ends)
  • Change from Baseline in waist circumference(Baseline and 6 weeks immediately after the interventions ends)
  • Change from Baseline in fasting insulin(Baseline and 6 weeks immediately after the interventions ends)
  • Change from Baseline in one maximum repetition strength test of biceps curl exercise(Baseline and 6 weeks immediately after the interventions ends)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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