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

Primary Purpose

Metabolism Disorder, Insulin Sensitivity, Obesity, Pediatric

Status

Completed

Phase

Not Applicable

Locations

Colombia

Study Type

Interventional

Intervention

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

Control group

About this trial

This is an interventional prevention trial for Metabolism Disorder

Eligibility Criteria

9 Years - 13 Years (Child)All SexesAccepts 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.

Sites / Locations

Robinson Ramírez-Vélez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Control group

Arm 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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline in body mass

Change from Baseline in body mass index

Change from Baseline in waist circumference

Change from Baseline in fat mass

Change from Baseline in blood pressure

Change from Baseline in fasting glucose

Change from Baseline in fasting insulin

Change from Baseline in one maximum repetition strength test of leg-extension exercise

Change from Baseline in one maximum repetition strength test of shoulder press exercise

Change from Baseline in one maximum repetition strength test of upper-row exercise

Change from Baseline in one maximum repetition strength test of biceps curl exercise

Full Information

NCT ID

NCT03003754

First Posted

December 22, 2016

Last Updated

October 10, 2018

Sponsor

Universidad Santo Tomas

Collaborators

Healthcare Center Tomas Rojas, Health Service of Los Ríos by the Health promotion program, Universidad Pública de Navarra, Universidad del Rosario

1. Study Identification

Unique Protocol Identification Number

NCT03003754

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

June 2015 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universidad Santo Tomas

Collaborators

Healthcare Center Tomas Rojas, Health Service of Los Ríos by the Health promotion program, Universidad Pública de Navarra, Universidad del Rosario

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolism Disorder, Insulin Sensitivity, Obesity, Pediatric

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Control group

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame