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

Not Applicable

Completed

• Conditions: Insulin Sensitivity; Metabolism Disorder; Obesity, Pediatric
• Interventions: Behavioral: Control group; Behavioral: High Intensity Training (HIT) + Resistance Training (RT)

• Registration Number: NCT03003754
• Lead Sponsor: Universidad Santo Tomas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2016-12
• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2016-12-22
• Study First Posted: 2016-12-28
• Study Completion: 2017-02
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	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).
High Intensity Training (HIT) + Resistance Training (RT)	High Intensity Training (HIT) + Resistance Training (RT)	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in plasma homeostasis model assessment (HOMA-IR)	Baseline and 6 weeks immediately after the interventions ends

Secondary Outcome Measures

Name	Time	Method
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 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 one maximum repetition strength test of biceps curl exercise	Baseline and 6 weeks immediately after the interventions ends

Trial Locations

Locations (1)

Robinson Ramírez-Vélez; 🇨🇴 Bogota Distrito Especial, Cundinamarca, Colombia