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Brief Summary

Background Risk factors for cardiometabolic diseases have their onset in infancy. Comorbidities such as overweight, abdominal obesity, hypertension, insulin resistance and elevated triglycerides have been observed in childhood with a tendency to persist into adult life. Furthermore, this situation has generated an increase in morbidity and mortality rates due to chronic non-communicable diseases. One approach to decrease the impact of cardiometabolic diseases is the intervention with exercise training (strength and aerobic capacity), where an important role of protein intake plays a role in influencing the performance of strength training, due to the greater utilization of low-energy protein compared to aerobic exercise. In children, a better tolerance was reported in muscle strength exercises, with at least one supervised training session per week with moderate intensity (20 minutes of physical activity). Currently, there is no consensus on the minimum time required to intervene and achieve significant changes in the metabolic profile of adolescents and children. Objective To evaluate the relationship between weight at birth and adaptations to aerobic exercise and muscular strength, and its effects on metabolic risk, body composition and physical capacity. Methodology An experimental study with individual analysis per participant would be perform. The sample will include a 12 to 17-year-old adolescent population. It will consist of two phases. The intervention will be based on moderate strength, power and resistance training programs, and/or moderate aerobic capacity exercise in circuit steps. The workouts will be done two times a week, approximately 30 to 40 minutes including warm-up, stretching and cooling. All participants personal and family history data would be collected and blood samples would be taken. Potential results Within the expected results, the protocol wants to implement a new methodology of physical capacity training. Furthermore, the protocol will evaluate if related cardiometabolic risk factors with the intervention would improve in target patients at risk of developing cardiometabolic diseases to identify them and prevent the occurrence of these pathologies in adult life.

Outcome Measures

Primary Outcomes (3)

% of change in the glucose levels within the experimental groups with the habitual training
Evaluation of cardiometabolic risk factors related to physical training to take into account in patients with a risk of developing cardiometabolic diseases and that have as antecedents low birth weight to identify them and prevent the appearance of these pathologies that affect the health and quality of life
Twelve months
% of change in the body mass index within the experimental groups with the habitual training
Evaluation of cardiometabolic risk factors related to physical training to take into account in patients with a risk of developing cardiometabolic diseases and that have as antecedents low birth weight to identify them and prevent the appearance of these pathologies that affect the health and quality of life
Twelve months
% of change in the lipid profile levels within the experimental groups with the habitual training
Evaluation of cardiometabolic risk factors related to physical training to take into account in patients with a risk of developing cardiometabolic diseases and that have as antecedents low birth weight to identify them and prevent the appearance of these pathologies that affect the health and quality of life
Twelve months

Secondary Outcomes (3)

% change in the hand grip strenght test within the experimental groups with the habitual training
Twelve months
% change in the flexibility within the experimental groups with the habitual training
Twelve months
% change in the vertical jump within the experimental groups with the habitual training
Twelve months

Study Arms (3)

Habitual training

ACTIVE COMPARATOR

The control group will be monitored passively for the detection of adverse or secondary events.

Behavioral: Muscular Resistance trainingBehavioral: Cardiorespiratory training

Muscular resistance training

EXPERIMENTAL

This phase includes the execution of the study with three arms, one group will be assigned to strength training and the other to aerobic capacity training, taking into account the plan of sessions per week.

Behavioral: Habitual training

Cardiorespiratory training

EXPERIMENTAL

Related Publications (93)

Cohen DD, Gomez-Arbelaez D, Camacho PA, Pinzon S, Hormiga C, Trejos-Suarez J, Duperly J, Lopez-Jaramillo P. Low muscle strength is associated with metabolic risk factors in Colombian children: the ACFIES study. PLoS One. 2014 Apr 8;9(4):e93150. doi: 10.1371/journal.pone.0093150. eCollection 2014.

PMID: 24714401BACKGROUND

Raitakari OT, Juonala M, Kahonen M, Taittonen L, Laitinen T, Maki-Torkko N, Jarvisalo MJ, Uhari M, Jokinen E, Ronnemaa T, Akerblom HK, Viikari JS. Cardiovascular risk factors in childhood and carotid artery intima-media thickness in adulthood: the Cardiovascular Risk in Young Finns Study. JAMA. 2003 Nov 5;290(17):2277-83. doi: 10.1001/jama.290.17.2277.

PMID: 14600186BACKGROUND

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

INVESTIGATOR, OUTCOMES ASSESSOR

Masking Details

The person responsible for the analyzes will be blind about the interventions. The analysis will be by intention to treat. There would be three arms of the study (strength group, aerobic exercise group and control group) of adolescents of 12 to 17 years old. A balanced randomization will be carried out using random numbers generated in software systematized form, guaranteeing the homogeneity of the number of subjects in each arm, with internal random assignment with a ratio of 1:1:1 to receive the study intervention.

Purpose

PREVENTION

Intervention Model

PARALLEL

Model Details: The study is divided into two phases carried out in several visits: Phase I is constituted by a visit -1 and 1, which includes the selection of the sample and the randomization. Phase II includes the execution of the study with three arms, one group will be assigned to strength training and the other to aerobic capacity training, taking into account the plan of sessions per week defined for SIMAC (three sessions). The control group will be monitored passively for the detection of adverse or secondary events. At the end of this phase, anthropometric, clinical and biochemical markers will be monitored in the two intervention groups and in the control group. In Phase III a combined program of strength and aerobic capacity will be implemented, which will last six months more than will be compared with the previously defined control group.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Principal Investigator

Resistance and Aerobic Training, Relationship With Birth Weight in Colombian Children

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (3)

Habitual training

Muscular resistance training

Cardiorespiratory training

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (93)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (3)

Habitual training

Muscular resistance training

Cardiorespiratory training

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (93)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record