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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03779737
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : December 27, 2018
Sponsor:
Collaborators:
Universidad de Santander
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Information provided by (Responsible Party):
Paul Anthony Camacho Lopez, Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

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.


Condition or disease Intervention/treatment Phase
Resistance Training Cardiovascular Risk Low Birth Weight Behavioral: Muscular Resistance training Behavioral: Cardiorespiratory training Behavioral: Habitual training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Muscular Strength and Aerobic Capacity, a Symbiotic Relationship With Birth Weight and Metabolic Risk of Colombian Scholchildren: Study SIMAC
Study Start Date : February 1, 2016
Actual Primary Completion Date : July 30, 2016
Actual Study Completion Date : December 10, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Habitual training
The control group will be monitored passively for the detection of adverse or secondary events.
Behavioral: Muscular Resistance training
Behavioral: Cardiorespiratory training
Experimental: Muscular resistance training
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
Experimental: Cardiorespiratory training
In stage, 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.
Behavioral: Habitual training



Primary Outcome Measures :
  1. % of change in the glucose levels within the experimental groups with the habitual training [ Time Frame: Twelve months ]
    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

  2. % of change in the body mass index within the experimental groups with the habitual training [ Time Frame: Twelve months ]
    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

  3. % of change in the lipid profile levels within the experimental groups with the habitual training [ Time Frame: Twelve months ]
    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


Secondary Outcome Measures :
  1. % change in the hand grip strenght test within the experimental groups with the habitual training [ Time Frame: Twelve months ]
    % change in physical fitness in the participants of the experimental group compared to the control group in hand grip strenght test , as markers of cardiometabolic risk (glucose, lipid profile and body mass index)

  2. % change in the flexibility within the experimental groups with the habitual training [ Time Frame: Twelve months ]
    % change in physical fitness in the participants of the experimental group compared to the control group in flexibility with sit and reach, as markers of cardiometabolic risk (glucose, lipid profile and BMI)

  3. % change in the vertical jump within the experimental groups with the habitual training [ Time Frame: Twelve months ]
    % change in physical fitness in the participants of the experimental group compared to the control group in vertical jump, as markers of cardiometabolic risk (glucose, lipid profile and BMI)



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adolescents 12-17 years old.
  • Tanner 3 at medical evaluation.
  • Provide reliable information on birth weight and gestational age.
  • For the group of Low birth weight: birth weight below 2800 gr. For the group of normal birth weight: birth weight between 2800 - 4000 gr

Exclusion Criteria:

  • Express voluntarily desire for non-participation by parents in the study.
  • Teenager's desire of not to be included in the study.
  • Adolescents with physical disability that prevents them from engaging in a physical training program focused on strengthening.
  • Adolescents with asthma.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779737


Sponsors and Collaborators
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Universidad de Santander
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Investigators
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Study Director: PATRICIO LOPEZ, JARAMILLO FUNDACION OFTALMOLOGICA DE SANTANDER
Publications:
OMS OMdlS-. Estrategia mundial sobre régimen alimentario, actividad física y salud. [updated 12-06-2014; cited 2014 12-06-2014]; Available from: http://www.who.int/dietphysicalactivity/childhood/es/.
López-Jaramillo P, López-López J. Fetal programming and cardiometabolic diseases: the role of angiotensin II and inflammation. Clínica e Investigación en Arteriosclerosis. 2010;22, Supplement 2(0):21-4.
López Jaramillo P, Gómez Arbeláez D, Cohen DD, Camacho PA, Rincón Romero K, Hormiga C, et al. Association between obesity and low muscular and cardiorespiratory capacity, cardiometabolic risk factors in Colombian children. Trauma. 2013;24(1):17-23.
Lopez P. Capítulo 1: Las enfermedades Cardiovasculares en los países subdesarrollados Bioquímica del endotelio vascular: Implicaciones fisiológicas y clínicas 2001. p. 21 - 34.
Batería ALPHA-Fitness: Test de campo para la evaluación de la condición física relacionada con la salud en niños y adolescentes.Pag 21
RICKE O, SCHOENAU E ibid Pag 228
ESCALONA P, NARANJO J,LAGOS V, SOLÍS F. Normal Parameters in Hand Grasping Strength in subjects of both genders, 7 to 17 years of age. Rev Chil Pediatr 2009; 80 (5): 435-443
FLORES-HUERTA S. Antropometría, estado nutricio y salud de los niños. Importancia de las mediciones comparables. Bol Med Hosp Infant Mex. Vol. 63, Marzo-Abril 2006. Pag. 74.

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Responsible Party: Paul Anthony Camacho Lopez, Principal Investigator, Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
ClinicalTrials.gov Identifier: NCT03779737    
Other Study ID Numbers: 651765741093
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Body Weight
Birth Weight