<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03779737</url>
  </required_header>
  <id_info>
    <org_study_id>651765741093</org_study_id>
    <nct_id>NCT03779737</nct_id>
  </id_info>
  <brief_title>Resistance and Aerobic Training, Relationship With Birth Weight in Colombian Children</brief_title>
  <acronym>SIMAC</acronym>
  <official_title>Muscular Strength and Aerobic Capacity, a Symbiotic Relationship With Birth Weight and Metabolic Risk of Colombian Scholchildren: Study SIMAC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad de Santander</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background Risk factors for cardiometabolic diseases have their onset in infancy.&#xD;
      Comorbidities such as overweight, abdominal obesity, hypertension, insulin resistance and&#xD;
      elevated triglycerides have been observed in childhood with a tendency to persist into adult&#xD;
      life. Furthermore, this situation has generated an increase in morbidity and mortality rates&#xD;
      due to chronic non-communicable diseases. One approach to decrease the impact of&#xD;
      cardiometabolic diseases is the intervention with exercise training (strength and aerobic&#xD;
      capacity), where an important role of protein intake plays a role in influencing the&#xD;
      performance of strength training, due to the greater utilization of low-energy protein&#xD;
      compared to aerobic exercise. In children, a better tolerance was reported in muscle strength&#xD;
      exercises, with at least one supervised training session per week with moderate intensity (20&#xD;
      minutes of physical activity). Currently, there is no consensus on the minimum time required&#xD;
      to intervene and achieve significant changes in the metabolic profile of adolescents and&#xD;
      children.&#xD;
&#xD;
      Objective To evaluate the relationship between weight at birth and adaptations to aerobic&#xD;
      exercise and muscular strength, and its effects on metabolic risk, body composition and&#xD;
      physical capacity.&#xD;
&#xD;
      Methodology An experimental study with individual analysis per participant would be perform.&#xD;
      The sample will include a 12 to 17-year-old adolescent population. It will consist of two&#xD;
      phases. The intervention will be based on moderate strength, power and resistance training&#xD;
      programs, and/or moderate aerobic capacity exercise in circuit steps. The workouts will be&#xD;
      done two times a week, approximately 30 to 40 minutes including warm-up, stretching and&#xD;
      cooling. All participants personal and family history data would be collected and blood&#xD;
      samples would be taken.&#xD;
&#xD;
      Potential results Within the expected results, the protocol wants to implement a new&#xD;
      methodology of physical capacity training. Furthermore, the protocol will evaluate if related&#xD;
      cardiometabolic risk factors with the intervention would improve in target patients at risk&#xD;
      of developing cardiometabolic diseases to identify them and prevent the occurrence of these&#xD;
      pathologies in adult life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type of study: Experimental study with individual analysis. Population object and sample:&#xD;
      Adolescents from 12 to 17 years old of high school located in Bucaramanga's metropolitan&#xD;
      area. The sample size was calculated to evaluate the difference between the maximum oxygen&#xD;
      consumption (VO2max) between the control group and 20% of the intervention groups using an&#xD;
      ANCOVA method, with a correlation of 0.5 between the initial and final evaluations. An error&#xD;
      alpha of 0.05 and power of 0.8, obtaining a sample of 60 adolescents for each group.&#xD;
&#xD;
      Description of the physical intervention or program: This is a strength, power and endurance&#xD;
      training program of moderate intensity combined with aerobic capacity training Moderate in&#xD;
      the form of circuit. The trainings will be performed twice a week between 30-60 minutes of&#xD;
      training, 1 hour including heating, stretching, explanations and cooling.&#xD;
&#xD;
      Baseline assessment: All adolescents will be provided with a CRF for past medical history and&#xD;
      family history, a review of systems and physical examination. In addition, the following&#xD;
      evaluation protocol is established: Health related physical fitness measurement (AFRS):&#xD;
      Aerobic capacity, maximal strength, 6RM submaximal strength test, strength, power, muscular&#xD;
      endurance and flexibility; Anthropometric measurements and body composition; Complete Blood&#xD;
      Count (CBC), and Lipid Profile. Measurements with AFRS will be taken at baseline, after 3&#xD;
      months of the program and at the end (6 months).&#xD;
&#xD;
      Aerobic capacity: To measure the aerobic capacity, 20 Meter Shuttle Run Test will be applied.&#xD;
      A site would be selected for the test, preferably a space of 25 meter or longer. It would&#xD;
      need 4 cones, tape measure, compact disc (CD) with the test protocol and a CD player. The two&#xD;
      ends of the 20-meter track should be clearly marked. For the execution, the adolescent will&#xD;
      move from one line to another located 20 meters away and making the change of direction to&#xD;
      the rhythm that is indicated by a sound signal that will progressively accelerate. The&#xD;
      initial velocity of the signal would be 8.5 km/hr, and will increase by 0.5 km/hr/min (1&#xD;
      minute is equal to one shuttle). The test will end when the adolescent is not able to arrive&#xD;
      for the second time in a row to the start line with the audio signal. Otherwise, the test&#xD;
      will end when the teen stops because of fatigue. The participant would start running when the&#xD;
      CD player emits the sound. The participant will touch the line at the end of the track with&#xD;
      the feet, turn abruptly and run in the opposite direction. At first the speed will be low,&#xD;
      but it will increase slowly and steadily every minute. The participant will stop when they no&#xD;
      longer can keep the pace set. Or if they feel unable to complete the one-minute period. It is&#xD;
      important to remember the last number announced by the CD player when the participant stops,&#xD;
      because this will be the participant's score. This test would be performed only once. When&#xD;
      the schoolchildren finish the test or cannot keep the pace, the last completed palier would&#xD;
      be recorded.&#xD;
&#xD;
      Maximum isometric force: Hand dynamometry is an important test for assessing the physical&#xD;
      performance and nutritional status of the participants and allows reference to the isometric&#xD;
      muscular strength of the hand. The improve in muscle strengths are inversely associated with&#xD;
      changes in total adiposity in childhood and adolescence. This test requires an adjustable&#xD;
      dynamometer (TKK 5101 Grip D; Takey, Tokyo Japan) and a Right- and left-Hand Grip Rule. The&#xD;
      Adolescent will tighten the dynamometer gradually and continuously for less than 2 seconds,&#xD;
      performing the test twice (alternately with both hands) with the optimal grip adjustment&#xD;
      according to the size of the hand (previously calculated with the hand grip rule). Allowing a&#xD;
      short break between measurements for each measurement. The elbow should be in all its&#xD;
      extension and the participant has to avoid the contact of the dynamometer with any part of&#xD;
      the body. The Adolescent will take the dynamometer with one hand, try to apply the mayor&#xD;
      strength possible. Would Squeeze gradually and continuously for less than 2 or 3 seconds. The&#xD;
      examiner will show the correct form of execution. Adjust the grip measure according the size&#xD;
      of the hand. The test will be done twice and the best result will be recorded. The maximum&#xD;
      duration of the test will be 3-5 seconds, the size of the hand (right or left) should be&#xD;
      measured to the maximum width. The accuracy of the measurement is 0.5 cm. During the test,&#xD;
      the arm and hand holding the dynamometer do not touch the body. The instrument is held in&#xD;
      line with the forearm. After a short break, a second attempt will be made.&#xD;
&#xD;
      Power: Vertical Jump Test is a test that measures the length reached in the vertical jump and&#xD;
      with the Lewis's formula can calculate the power of the Adolescent. In addition, the&#xD;
      participants can measure the force of the jump with a Platform Kinetics. To use it, the&#xD;
      adolescent must stand at a side of a wall, and bring the hand closer to the wall, keeping&#xD;
      their feet on the platform. They would have to jump vertically as high as possible with both&#xD;
      legs. The platform kinetics would record the best of the three attempts. The participant must&#xD;
      put the hands by the hips, to isolate the muscles of the legs. And three attempts are made to&#xD;
      allow the coordination of arm movements. The vertical jump test is performed against a&#xD;
      movement, where there is flexion of the knees before the jump. The necessary equipment to&#xD;
      carry out this activity is the force plate (PASCO, USA, software, NMP technologies, London,&#xD;
      UK).&#xD;
&#xD;
      Explosive force: The long jump test allows to measure muscle strength. For the test is needed&#xD;
      a non-slip surface, a tape measure, tape and cones. The teenager is going to stand behind the&#xD;
      jump line, they must stand with their feet in an equal distance to the anchor of their&#xD;
      shoulders, parallel to the ground. Subsequently they will bend the knees with the arms in&#xD;
      front of the body and from that position they will balance the arms, they will push with&#xD;
      force and jump as far as possible. they will land on both feet simultaneously and in an&#xD;
      upright position. The examiner will show the correct form of execution; the test will be done&#xD;
      twice and the best result will be recorded. The horizontal lines of measurement are drawn in&#xD;
      the drop landing zone at 10 cm, from 1 m from the take-off line. A tape measure is going to&#xD;
      be put perpendicular to these lines. The examiner would be remained by the tape measure and&#xD;
      will record the distance jumped by the adolescent. The jumped distance will be measured from&#xD;
      the takeoff line to the back of the heel nearest to that line. A new attempt is allowed if&#xD;
      the teenager falls backwards or contacts the surface with another part of the body.&#xD;
&#xD;
      Strength of resistance: Using the same test and the high jump protocol, but the participants&#xD;
      would have to jump repeatedly for 15 seconds. The test is implemented with a Platform that&#xD;
      allows the evaluation of the time in flight, time of contact between jumps and the power in&#xD;
      each jump. The resistance is calculated with the average of these variables for 15 seconds&#xD;
      and a fatigue index.&#xD;
&#xD;
      6-RM submaximal strength test: The American Academy of Pediatrics recommends strength&#xD;
      training in the adolescent with a load adjusted to the ability of the Adolescent and with 6&#xD;
      maximal repetitions (6RM), which means that loading in an exercise should allow adolescents&#xD;
      achieve 6 concentric and eccentric movements with good technique. In the program use a range&#xD;
      of loads (RM's) It is going to be lighter adjusted to the assessment of the beginning of the&#xD;
      program, and after every 6 weeks of training, the protocol will implement the test of 6 RM in&#xD;
      exercise in machines (chest press, folding, shoulder press, extension of the Leg) to adjust&#xD;
      the load according to the progression of the strength of each adolescent.&#xD;
&#xD;
      Flexibility: The protocol can define flexibility as the ability of the individual to get&#xD;
      his/her body placed in as many positions as possible, both statics and moving positions. This&#xD;
      implies a great capacity of mobility of the different corporal segments with an ample freedom&#xD;
      of corporal movements.&#xD;
&#xD;
      Weight: The adolescent would be placed in the center of the scale in a standard upright&#xD;
      position, without the body being in contact with anything around him/her. The participant&#xD;
      will remain in the described position on the previously calibrated weight balance and it&#xD;
      would be determined the weight in Kilograms.&#xD;
&#xD;
      Size: Have the participant stand erect on the floor board of the stadiometer with his or her&#xD;
      back to the vertical backboard of the stadiometer. The weight of the participant is evenly&#xD;
      distributed on both feet. The heels of the feet are placed together with both heels touching&#xD;
      the base of the vertical board. Place the feet pointed slightly outward at a 60-degree angle.&#xD;
      The adolescent will remain standing, keeping the position of Anthropometric attention with&#xD;
      the heels, glutes, back and occipital region in contact with the vertical plane of the&#xD;
      tallimeter. The evaluator makes an in-depth inspiration at the time of the measurement to&#xD;
      compensate for the shortening of the intervertebral discs.&#xD;
&#xD;
      Body mass index - BMI: The body mass index or the Quetelet index, has been defined as the&#xD;
      ratio of weight to height squared (kilogram/m2). This index changes substantially with age,&#xD;
      at birth, is as low as 13 kg/m2. The CDC proposes to use as cutoffs of the 85th and 95th&#xD;
      percentile of its own data.&#xD;
&#xD;
      Development of the study: There would be three arms of the study (strength group, aerobic&#xD;
      exercise group and control group) of adolescents of 12 to 17 years old. The person&#xD;
      responsible for the analyzes will be blind about the interventions. The analysis will be by&#xD;
      intention to treat. Once the inclusion/exclusion criteria are checked, the selected&#xD;
      candidates will receive information about the study objectives and methodology, and finally&#xD;
      the adolescent will sign the informed consent and the guardian or responsible of the child&#xD;
      will sign the informed consent too. After the screening procedures and the initial evaluation&#xD;
      of the inclusion and selection criteria, the patients will begin the initial evaluation&#xD;
      period. A balanced randomization will be carried out using random numbers generated in&#xD;
      software systematized form, guaranteeing the homogeneity of the number of subjects in each&#xD;
      arm, with internal random assignment with a ratio of 1:1:1 to receive the study intervention.&#xD;
      This study is designed with a primary efficacy endpoint at six months and at twelve months.&#xD;
      Upon completion of 6 months of intervention, the strength and aerobic capacity groups would&#xD;
      be integrated into a single group to evaluate the combined effect of the interventions versus&#xD;
      the control group.&#xD;
&#xD;
      The study is divided into two phases carried out in several visits: Phase I is constituted by&#xD;
      a visit -1 and 1, which includes the selection of the sample and the randomization. Phase II&#xD;
      includes the execution of the study with three arms, one group will be assigned to strength&#xD;
      training and the other to aerobic capacity training, taking into account the plan of sessions&#xD;
      per week defined for SIMAC (three sessions). The control group will be monitored passively&#xD;
      for the detection of adverse or secondary events. At the end of this phase, anthropometric,&#xD;
      clinical and biochemical markers will be monitored in the two intervention groups and in the&#xD;
      control group. In Phase III a combined program of strength and aerobic capacity will be&#xD;
      implemented, which will last six months more than will be compared with the previously&#xD;
      defined control group. Again, at the end of phase III, the outcomes related to possible&#xD;
      changes in the anthropometric, clinical and biochemical markers in the two groups will be&#xD;
      evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 1, 2016</start_date>
  <completion_date type="Actual">December 10, 2016</completion_date>
  <primary_completion_date type="Actual">July 30, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>% of change in the glucose levels within the experimental groups with the habitual training</measure>
    <time_frame>Twelve months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>% of change in the body mass index within the experimental groups with the habitual training</measure>
    <time_frame>Twelve months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>% of change in the lipid profile levels within the experimental groups with the habitual training</measure>
    <time_frame>Twelve months</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>% change in the hand grip strenght test within the experimental groups with the habitual training</measure>
    <time_frame>Twelve months</time_frame>
    <description>% 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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% change in the flexibility within the experimental groups with the habitual training</measure>
    <time_frame>Twelve months</time_frame>
    <description>% 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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% change in the vertical jump within the experimental groups with the habitual training</measure>
    <time_frame>Twelve months</time_frame>
    <description>% 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)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Resistance Training</condition>
  <condition>Cardiovascular Risk</condition>
  <condition>Low Birth Weight</condition>
  <arm_group>
    <arm_group_label>Habitual training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will be monitored passively for the detection of adverse or secondary events.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Muscular resistance training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cardiorespiratory training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Muscular Resistance training</intervention_name>
    <arm_group_label>Habitual training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cardiorespiratory training</intervention_name>
    <arm_group_label>Habitual training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Habitual training</intervention_name>
    <arm_group_label>Cardiorespiratory training</arm_group_label>
    <arm_group_label>Muscular resistance training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescents 12-17 years old.&#xD;
&#xD;
          -  Tanner 3 at medical evaluation.&#xD;
&#xD;
          -  Provide reliable information on birth weight and gestational age.&#xD;
&#xD;
          -  For the group of Low birth weight: birth weight below 2800 gr. For the group of normal&#xD;
             birth weight: birth weight between 2800 - 4000 gr&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Express voluntarily desire for non-participation by parents in the study.&#xD;
&#xD;
          -  Teenager's desire of not to be included in the study.&#xD;
&#xD;
          -  Adolescents with physical disability that prevents them from engaging in a physical&#xD;
             training program focused on strengthening.&#xD;
&#xD;
          -  Adolescents with asthma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>PATRICIO LOPEZ, JARAMILLO</last_name>
    <role>Study Director</role>
    <affiliation>FUNDACION OFTALMOLOGICA DE SANTANDER</affiliation>
  </overall_official>
  <reference>
    <citation>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.</citation>
    <PMID>24714401</PMID>
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    <PMID>19480763</PMID>
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    <PMID>18645341</PMID>
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    <citation>Ridgway CL, Brage S, Anderssen S, Sardinha LB, Andersen LB, Ekelund U. Fat-free mass mediates the association between birth weight and aerobic fitness in youth. Int J Pediatr Obes. 2011 Jun;6(2-2):e590-6. doi: 10.3109/17477166.2010.526225. Epub 2010 Nov 4.</citation>
    <PMID>21050079</PMID>
  </reference>
  <reference>
    <citation>Brons C, Jensen CB, Storgaard H, Alibegovic A, Jacobsen S, Nilsson E, Astrup A, Quistorff B, Vaag A. Mitochondrial function in skeletal muscle is normal and unrelated to insulin action in young men born with low birth weight. J Clin Endocrinol Metab. 2008 Oct;93(10):3885-92. doi: 10.1210/jc.2008-0630. Epub 2008 Jul 15.</citation>
    <PMID>18628517</PMID>
  </reference>
  <reference>
    <citation>Ruiz JR, Espana Romero V, Castro Pinero J, Artero EG, Ortega FB, Cuenca Garcia M, Jimenez Pavon D, Chillon P, Girela Rejon MJ, Mora J, Gutierrez A, Suni J, Sjostrom M, Castillo MJ. [ALPHA-fitness test battery: health-related field-based fitness tests assessment in children and adolescents]. Nutr Hosp. 2011 Nov-Dec;26(6):1210-4. doi: 10.1590/S0212-16112011000600003. Spanish.</citation>
    <PMID>22411362</PMID>
  </reference>
  <reference>
    <citation>Tremblay MS, Shields M, Laviolette M, Craig CL, Janssen I, Connor Gorber S. Fitness of Canadian children and youth: results from the 2007-2009 Canadian Health Measures Survey. Health Rep. 2010 Mar;21(1):7-20.</citation>
    <PMID>20426223</PMID>
  </reference>
  <reference>
    <citation>Cohen DD, Voss C, Taylor MJ, Stasinopoulos DM, Delextrat A, Sandercock GR. Handgrip strength in English schoolchildren. Acta Paediatr. 2010 Jul;99(7):1065-72. doi: 10.1111/j.1651-2227.2010.01723.x. Epub 2010 Feb 19.</citation>
    <PMID>20178516</PMID>
  </reference>
  <reference>
    <citation>Marrodan Serrano MD, Romero Collazos JF, Moreno Romero S, Mesa Santurino MS, Cabanas Armesilla MD, Pacheco Del Cerro JL, Gonzalez-Montero de Espinosa M. [Handgrip strength in children and teenagers aged from 6 to 18 years: reference values and relationship with size and body composition]. An Pediatr (Barc). 2009 Apr;70(4):340-8. doi: 10.1016/j.anpedi.2008.11.025. Epub 2009 Mar 5. Spanish.</citation>
    <PMID>19268640</PMID>
  </reference>
  <reference>
    <citation>RICKE O, SCHOENAU E ibid Pag 228</citation>
  </reference>
  <reference>
    <citation>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</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>Fuller NJ, Fewtrell MS, Dewit O, Elia M, Wells JC. Segmental bioelectrical impedance analysis in children aged 8-12 y: 2. The assessment of regional body composition and muscle mass. Int J Obes Relat Metab Disord. 2002 May;26(5):692-700. doi: 10.1038/sj.ijo.0801989.</citation>
    <PMID>12032755</PMID>
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  <reference>
    <citation>Kilani H, Abu-Eisheh A. Optimum anthropometric criteria for ideal body composition related fitness. Sultan Qaboos Univ Med J. 2010 Apr;10(1):74-9. Epub 2010 Apr 17.</citation>
    <PMID>21509084</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>December 15, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 26, 2018</last_update_submitted>
  <last_update_submitted_qc>December 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle</investigator_affiliation>
    <investigator_full_name>Paul Anthony Camacho Lopez</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Birth Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03779737
org study id: 651765741093
nct id: NCT03779737
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
Type of study: Experimental study with individual analysis. Population object and sample:
      Adolescents from 12 to 17 years old of high school located in Bucaramanga's metropolitan
      area. The sample size was calculated to evaluate the difference between the maximum oxygen
      consumption (VO2max) between the control group and 20% of the intervention groups using an
      ANCOVA method, with a correlation of 0.5 between the initial and final evaluations. An error
      alpha of 0.05 and power of 0.8, obtaining a sample of 60 adolescents for each group.

      Description of the physical intervention or program: This is a strength, power and endurance
      training program of moderate intensity combined with aerobic capacity training Moderate in
      the form of circuit. The trainings will be performed twice a week between 30-60 minutes of
      training, 1 hour including heating, stretching, explanations and cooling.

      Baseline assessment: All adolescents will be provided with a CRF for past medical history and
      family history, a review of systems and physical examination. In addition, the following
      evaluation protocol is established: Health related physical fitness measurement (AFRS):
      Aerobic capacity, maximal strength, 6RM submaximal strength test, strength, power, muscular
      endurance and flexibility; Anthropometric measurements and body composition; Complete Blood
      Count (CBC), and Lipid Profile. Measurements with AFRS will be taken at baseline, after 3
      months of the program and at the end (6 months).

      Aerobic capacity: To measure the aerobic capacity, 20 Meter Shuttle Run Test will be applied.
      A site would be selected for the test, preferably a space of 25 meter or longer. It would
      need 4 cones, tape measure, compact disc (CD) with the test protocol and a CD player. The two
      ends of the 20-meter track should be clearly marked. For the execution, the adolescent will
      move from one line to another located 20 meters away and making the change of direction to
      the rhythm that is indicated by a sound signal that will progressively accelerate. The
      initial velocity of the signal would be 8.5 km/hr, and will increase by 0.5 km/hr/min (1
      minute is equal to one shuttle). The test will end when the adolescent is not able to arrive
      for the second time in a row to the start line with the audio signal. Otherwise, the test
      will end when the teen stops because of fatigue. The participant would start running when the
      CD player emits the sound. The participant will touch the line at the end of the track with
      the feet, turn abruptly and run in the opposite direction. At first the speed will be low,
      but it will increase slowly and steadily every minute. The participant will stop when they no
      longer can keep the pace set. Or if they feel unable to complete the one-minute period. It is
      important to remember the last number announced by the CD player when the participant stops,
      because this will be the participant's score. This test would be performed only once. When
      the schoolchildren finish the test or cannot keep the pace, the last completed palier would
      be recorded.

      Maximum isometric force: Hand dynamometry is an important test for assessing the physical
      performance and nutritional status of the participants and allows reference to the isometric
      muscular strength of the hand. The improve in muscle strengths are inversely associated with
      changes in total adiposity in childhood and adolescence. This test requires an adjustable
      dynamometer (TKK 5101 Grip D; Takey, Tokyo Japan) and a Right- and left-Hand Grip Rule. The
      Adolescent will tighten the dynamometer gradually and continuously for less than 2 seconds,
      performing the test twice (alternately with both hands) with the optimal grip adjustment
      according to the size of the hand (previously calculated with the hand grip rule). Allowing a
      short break between measurements for each measurement. The elbow should be in all its
      extension and the participant has to avoid the contact of the dynamometer with any part of
      the body. The Adolescent will take the dynamometer with one hand, try to apply the mayor
      strength possible. Would Squeeze gradually and continuously for less than 2 or 3 seconds. The
      examiner will show the correct form of execution. Adjust the grip measure according the size
      of the hand. The test will be done twice and the best result will be recorded. The maximum
      duration of the test will be 3-5 seconds, the size of the hand (right or left) should be
      measured to the maximum width. The accuracy of the measurement is 0.5 cm. During the test,
      the arm and hand holding the dynamometer do not touch the body. The instrument is held in
      line with the forearm. After a short break, a second attempt will be made.

      Power: Vertical Jump Test is a test that measures the length reached in the vertical jump and
      with the Lewis's formula can calculate the power of the Adolescent. In addition, the
      participants can measure the force of the jump with a Platform Kinetics. To use it, the
      adolescent must stand at a side of a wall, and bring the hand closer to the wall, keeping
      their feet on the platform. They would have to jump vertically as high as possible with both
      legs. The platform kinetics would record the best of the three attempts. The participant must
      put the hands by the hips, to isolate the muscles of the legs. And three attempts are made to
      allow the coordination of arm movements. The vertical jump test is performed against a
      movement, where there is flexion of the knees before the jump. The necessary equipment to
      carry out this activity is the force plate (PASCO, USA, software, NMP technologies, London,
      UK).

      Explosive force: The long jump test allows to measure muscle strength. For the test is needed
      a non-slip surface, a tape measure, tape and cones. The teenager is going to stand behind the
      jump line, they must stand with their feet in an equal distance to the anchor of their
      shoulders, parallel to the ground. Subsequently they will bend the knees with the arms in
      front of the body and from that position they will balance the arms, they will push with
      force and jump as far as possible. they will land on both feet simultaneously and in an
      upright position. The examiner will show the correct form of execution; the test will be done
      twice and the best result will be recorded. The horizontal lines of measurement are drawn in
      the drop landing zone at 10 cm, from 1 m from the take-off line. A tape measure is going to
      be put perpendicular to these lines. The examiner would be remained by the tape measure and
      will record the distance jumped by the adolescent. The jumped distance will be measured from
      the takeoff line to the back of the heel nearest to that line. A new attempt is allowed if
      the teenager falls backwards or contacts the surface with another part of the body.

      Strength of resistance: Using the same test and the high jump protocol, but the participants
      would have to jump repeatedly for 15 seconds. The test is implemented with a Platform that
      allows the evaluation of the time in flight, time of contact between jumps and the power in
      each jump. The resistance is calculated with the average of these variables for 15 seconds
      and a fatigue index.

      6-RM submaximal strength test: The American Academy of Pediatrics recommends strength
      training in the adolescent with a load adjusted to the ability of the Adolescent and with 6
      maximal repetitions (6RM), which means that loading in an exercise should allow adolescents
      achieve 6 concentric and eccentric movements with good technique. In the program use a range
      of loads (RM's) It is going to be lighter adjusted to the assessment of the beginning of the
      program, and after every 6 weeks of training, the protocol will implement the test of 6 RM in
      exercise in machines (chest press, folding, shoulder press, extension of the Leg) to adjust
      the load according to the progression of the strength of each adolescent.

      Flexibility: The protocol can define flexibility as the ability of the individual to get
      his/her body placed in as many positions as possible, both statics and moving positions. This
      implies a great capacity of mobility of the different corporal segments with an ample freedom
      of corporal movements.

      Weight: The adolescent would be placed in the center of the scale in a standard upright
      position, without the body being in contact with anything around him/her. The participant
      will remain in the described position on the previously calibrated weight balance and it
      would be determined the weight in Kilograms.

      Size: Have the participant stand erect on the floor board of the stadiometer with his or her
      back to the vertical backboard of the stadiometer. The weight of the participant is evenly
      distributed on both feet. The heels of the feet are placed together with both heels touching
      the base of the vertical board. Place the feet pointed slightly outward at a 60-degree angle.
      The adolescent will remain standing, keeping the position of Anthropometric attention with
      the heels, glutes, back and occipital region in contact with the vertical plane of the
      tallimeter. The evaluator makes an in-depth inspiration at the time of the measurement to
      compensate for the shortening of the intervertebral discs.

      Body mass index - BMI: The body mass index or the Quetelet index, has been defined as the
      ratio of weight to height squared (kilogram/m2). This index changes substantially with age,
      at birth, is as low as 13 kg/m2. The CDC proposes to use as cutoffs of the 85th and 95th
      percentile of its own data.

      Development of the study: There would be three arms of the study (strength group, aerobic
      exercise group and control group) of adolescents of 12 to 17 years old. The person
      responsible for the analyzes will be blind about the interventions. The analysis will be by
      intention to treat. Once the inclusion/exclusion criteria are checked, the selected
      candidates will receive information about the study objectives and methodology, and finally
      the adolescent will sign the informed consent and the guardian or responsible of the child
      will sign the informed consent too. After the screening procedures and the initial evaluation
      of the inclusion and selection criteria, the patients will begin the initial evaluation
      period. 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.
      This study is designed with a primary efficacy endpoint at six months and at twelve months.
      Upon completion of 6 months of intervention, the strength and aerobic capacity groups would
      be integrated into a single group to evaluate the combined effect of the interventions versus
      the control group.

      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. Again, at the end of phase III, the outcomes related to possible
      changes in the anthropometric, clinical and biochemical markers in the two groups will be
      evaluated.
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.
primary purpose: Prevention
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.
measure: % of change in the glucose levels within the experimental groups with the habitual training
time frame: Twelve months
description: 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
measure: % of change in the body mass index within the experimental groups with the habitual training
time frame: Twelve months
description: 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
measure: % of change in the lipid profile levels within the experimental groups with the habitual training
time frame: Twelve months
description: 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
measure: % change in the hand grip strenght test within the experimental groups with the habitual training
time frame: Twelve months
description: % 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)
measure: % change in the flexibility within the experimental groups with the habitual training
time frame: Twelve months
description: % 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)
measure: % change in the vertical jump within the experimental groups with the habitual training
time frame: Twelve months
description: % 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)
arm group label: Habitual training
arm group type: Active Comparator
description: The control group will be monitored passively for the detection of adverse or secondary events.
arm group label: Muscular resistance training
arm group type: Experimental
description: 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.
arm group label: Cardiorespiratory training
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: Muscular Resistance training
arm group label: Habitual training
intervention type: Behavioral
intervention name: Cardiorespiratory training
arm group label: Habitual training
intervention type: Behavioral
intervention name: Habitual training
arm group label: Cardiorespiratory training
arm group label: Muscular resistance training
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: PATRICIO LOPEZ, JARAMILLO
role: Study Director
affiliation: FUNDACION OFTALMOLOGICA DE SANTANDER
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PMID: 24714401
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PMID: 14600186
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responsible party type: Principal Investigator
investigator affiliation: Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
investigator full name: Paul Anthony Camacho Lopez
investigator title: Principal Investigator
mesh term: Body Weight
mesh term: Birth Weight
sharing ipd: Undecided