Supervised Exercise-training in Children With Insulin Resistance or Healthy Metabolic Profile
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 22, 2016
CompletedFirst Posted
Study publicly available on registry
December 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedOctober 15, 2018
October 1, 2018
1.5 years
December 22, 2016
October 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in plasma homeostasis model assessment (HOMA-IR)
Baseline and 6 weeks immediately after the interventions ends
Secondary Outcomes (11)
Change from Baseline in body mass
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 fat mass
Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in blood pressure
Baseline and 6 weeks immediately after the interventions ends
- +6 more secondary outcomes
Study Arms (2)
High Intensity Training (HIT) + Resistance Training (RT)
EXPERIMENTALTo 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.
Control group
ACTIVE COMPARATORWe 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).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Potential medical, musculoskeletal problems or a familial history of T2DM,
- Ischemic disease,
- Arrhythmia,
- Asthma,
- Utilization of drugs that modulate the metabolic and respiratory control.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad Santo Tomaslead
- Healthcare Center Tomas Rojascollaborator
- Health Service of Los Ríos by the Health promotion programcollaborator
- Universidad Pública de Navarracollaborator
- Universidad del Rosariocollaborator
Study Sites (1)
Robinson Ramírez-Vélez
Bogota Distrito Especial, Cundinamarca, 000000000, Colombia
Related Publications (1)
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.
PMID: 28757639DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2016
First Posted
December 28, 2016
Study Start
June 1, 2015
Primary Completion
December 1, 2016
Study Completion
February 1, 2017
Last Updated
October 15, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share