Supervised Exercise-training in Children With Insulin Resistance or Healthy Metabolic Profile

Study Overview
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Brief Summary
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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.

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

Conditions
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Metabolism Disorder, Insulin Sensitivity, Obesity, Pediatric

Intervention / Treatment
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* Behavioral: High Intensity Training (HIT) + Resistance Training (RT)
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Potential medical, musculoskeletal problems or a familial history of T2DM, Ischemic disease, Arrhythmia, Asthma, Utilization of drugs that modulate the metabolic and respiratory control.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Training (HIT) + Resistance Training (RT)<br>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. | Behavioral: High Intensity Training (HIT) + Resistance Training (RT)<br>* Exercise will be performed at three sessions per week. Post statistical analyses will be including analyses by the 3 sub-groups proposed. All sessions will be supervised by an exercise physiologist during 6 weeks.<br>|
| Active Comparator: Control group<br>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). | Behavioral: Control group<br>* Post statistical analyses will be including analyses by the 3 sub-groups proposed Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in plasma homeostasis model assessment (HOMA-IR) |  | Baseline and 6 weeks immediately after the interventions ends | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in body mass |  | 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 fat mass |  | 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 fasting glucose |  | 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 leg-extension exercise |  | Baseline and 6 weeks immediately after the interventions ends | 
| 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 one maximum repetition strength test of upper-row exercise |  | 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 |