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

NCT ID: NCT03003754

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-02-28

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.

Conditions

Metabolism Disorder; Insulin Sensitivity; Obesity, Pediatric

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

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).

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Healthcare Center Tomas Rojas

OTHER

Sponsor Role: collaborator

Health Service of Los Ríos by the Health promotion program

UNKNOWN

Sponsor Role: collaborator

Universidad Pública de Navarra

OTHER

Sponsor Role: collaborator

Universidad del Rosario

OTHER

Sponsor Role: collaborator

Universidad Santo Tomas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Robinson Ramírez-Vélez

Bogota Distrito Especial, Cundinamarca, Colombia

Countries

Colombia

References

Alvarez C, Ramirez-Campillo R, Ramirez-Velez R, Martinez C, Castro-Sepulveda M, Alonso-Martinez A, Izquierdo M. Metabolic effects of resistance or high-intensity interval training among glycemic control-nonresponsive children with insulin resistance. Int J Obes (Lond). 2018 Jan;42(1):79-87. doi: 10.1038/ijo.2017.177. Epub 2017 Jul 31.

Reference Type: DERIVED

PMID: 28757639 (View on PubMed)

Other Identifiers

2016-12-22

Identifier Type: -

Identifier Source: org_study_id