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

Universidad Santo Tomas

Status: Completed

Conditions: Obesity, Pediatric; Insulin Sensitivity; Metabolism Disorder

Treatments: Behavioral: High Intensity Training (HIT) + Resistance Training (RT); Behavioral: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03003754

2016-12-22

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 9 to 13 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

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

Control group

Active Comparator group

Description:

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).

Treatment:

Behavioral: Control group