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

Sponsor
Universidad Santo Tomas (Other)
Overall Status
Completed
CT.gov ID
NCT03003754
Collaborator
Healthcare Center Tomas Rojas (Other), Health Service of Los Ríos by the Health promotion program (Other), Universidad Pública de Navarra (Other), Universidad del Rosario (Other)
60
1
2
20.1
3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: High Intensity Training (HIT) + Resistance Training (RT)
  • Behavioral: Control group
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Feb 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

Active Comparator: 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).

Behavioral: Control group
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.

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in plasma homeostasis model assessment (HOMA-IR) [Baseline and 6 weeks immediately after the interventions ends]

Secondary Outcome Measures

  1. Change from Baseline in body mass [Baseline and 6 weeks immediately after the interventions ends]

  2. Change from Baseline in body mass index [Baseline and 6 weeks immediately after the interventions ends]

  3. Change from Baseline in waist circumference [Baseline and 6 weeks immediately after the interventions ends]

  4. Change from Baseline in fat mass [Baseline and 6 weeks immediately after the interventions ends]

  5. Change from Baseline in blood pressure [Baseline and 6 weeks immediately after the interventions ends]

  6. Change from Baseline in fasting glucose [Baseline and 6 weeks immediately after the interventions ends]

  7. Change from Baseline in fasting insulin [Baseline and 6 weeks immediately after the interventions ends]

  8. Change from Baseline in one maximum repetition strength test of leg-extension exercise [Baseline and 6 weeks immediately after the interventions ends]

  9. Change from Baseline in one maximum repetition strength test of shoulder press exercise [Baseline and 6 weeks immediately after the interventions ends]

  10. Change from Baseline in one maximum repetition strength test of upper-row exercise [Baseline and 6 weeks immediately after the interventions ends]

  11. Change from Baseline in one maximum repetition strength test of biceps curl exercise [Baseline and 6 weeks immediately after the interventions ends]

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Robinson Ramírez-Vélez Bogota Distrito Especial Cundinamarca Colombia 000000000

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universidad Santo Tomas
ClinicalTrials.gov Identifier:
NCT03003754
Other Study ID Numbers:
  • 2016-12-22
First Posted:
Dec 28, 2016
Last Update Posted:
Oct 15, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2018