NCT03779737

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2017

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
Last Updated

December 27, 2018

Status Verified

December 1, 2018

Enrollment Period

6 months

First QC Date

September 28, 2017

Last Update Submit

December 26, 2018

Conditions

Resistance TrainingCardiovascular RiskLow Birth Weight

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

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

Interventions

Muscular Resistance trainingBEHAVIORAL
Habitual training
Cardiorespiratory trainingBEHAVIORAL
Habitual training
Habitual trainingBEHAVIORAL
Cardiorespiratory trainingMuscular resistance training

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

  • Lopez-Jaramillo P. Cardiometabolic disease in latin america: the role of fetal programming in response to maternal malnutrition. Rev Esp Cardiol. 2009 Jun;62(6):670-6. doi: 10.1016/s1885-5857(09)72231-5. English, Spanish.

    PMID: 19480763BACKGROUND

  • Steene-Johannessen J, Anderssen SA, Kolle E, Andersen LB. Low muscle fitness is associated with metabolic risk in youth. Med Sci Sports Exerc. 2009 Jul;41(7):1361-7. doi: 10.1249/MSS.0b013e31819aaae5.

    PMID: 19516166BACKGROUND

  • Lopez-Jaramillo P. Defining the research priorities to fight the burden of cardiovascular diseases in Latin America. J Hypertens. 2008 Sep;26(9):1886-9. doi: 10.1097/HJH.0b013e328308ba8d. No abstract available.

    PMID: 18698226BACKGROUND

  • 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/.

    BACKGROUND

  • Benson AC, Torode ME, Singh MA. Muscular strength and cardiorespiratory fitness is associated with higher insulin sensitivity in children and adolescents. Int J Pediatr Obes. 2006;1(4):222-31. doi: 10.1080/17477160600962864.

    PMID: 17907329BACKGROUND

  • Lopez-Jaramillo P, Lahera V, Lopez-Lopez J. Epidemic of cardiometabolic diseases: a Latin American point of view. Ther Adv Cardiovasc Dis. 2011 Apr;5(2):119-31. doi: 10.1177/1753944711403189. Epub 2011 Mar 15.

    PMID: 21406494BACKGROUND

  • Lopez-Jaramillo P, Silva SY, Rodriguez-Salamanca N, Duran A, Mosquera W, Castillo V. Are nutrition-induced epigenetic changes the link between socioeconomic pathology and cardiovascular diseases? Am J Ther. 2008 Jul-Aug;15(4):362-72. doi: 10.1097/MJT.0b013e318164bf9c.

    PMID: 18645341BACKGROUND

  • 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.

    BACKGROUND

  • Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.

    PMID: 15364185BACKGROUND

  • Lanas F, Avezum A, Bautista LE, Diaz R, Luna M, Islam S, Yusuf S; INTERHEART Investigators in Latin America. Risk factors for acute myocardial infarction in Latin America: the INTERHEART Latin American study. Circulation. 2007 Mar 6;115(9):1067-74. doi: 10.1161/CIRCULATIONAHA.106.633552.

    PMID: 17339564BACKGROUND

  • Gomez-Arbelaez D, Camacho PA, Cohen DD, Rincon-Romero K, Alvarado-Jurado L, Pinzon S, Duperly J, Lopez-Jaramillo P. Higher household income and the availability of electronic devices and transport at home are associated with higher waist circumference in Colombian children: the ACFIES study. Int J Environ Res Public Health. 2014 Feb 7;11(2):1834-43. doi: 10.3390/ijerph110201834.

    PMID: 24514426BACKGROUND

  • 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.

    BACKGROUND

  • Lopez-Jaramillo P, Herrera E, Garcia RG, Camacho PA, Castillo VR. Inter-relationships between body mass index, C-reactive protein and blood pressure in a Hispanic pediatric population. Am J Hypertens. 2008 May;21(5):527-32. doi: 10.1038/ajh.2007.86. Epub 2008 Mar 6.

    PMID: 18437144BACKGROUND

  • Tresierras MA, Balady GJ. Resistance training in the treatment of diabetes and obesity: mechanisms and outcomes. J Cardiopulm Rehabil Prev. 2009 Mar-Apr;29(2):67-75. doi: 10.1097/HCR.0b013e318199ff69.

    PMID: 19305230BACKGROUND

  • Faigenbaum AD, Westcott WL, Loud RL, Long C. The effects of different resistance training protocols on muscular strength and endurance development in children. Pediatrics. 1999 Jul;104(1):e5. doi: 10.1542/peds.104.1.e5.

    PMID: 10390291BACKGROUND

  • Faigenbaum AD, Milliken LA, Loud RL, Burak BT, Doherty CL, Westcott WL. Comparison of 1 and 2 days per week of strength training in children. Res Q Exerc Sport. 2002 Dec;73(4):416-24. doi: 10.1080/02701367.2002.10609041.

    PMID: 12495243BACKGROUND

  • Malina RM. Weight training in youth-growth, maturation, and safety: an evidence-based review. Clin J Sport Med. 2006 Nov;16(6):478-87. doi: 10.1097/01.jsm.0000248843.31874.be.

    PMID: 17119361BACKGROUND

  • Pikosky M, Faigenbaum A, Westcott W, Rodriguez N. Effects of resistance training on protein utilization in healthy children. Med Sci Sports Exerc. 2002 May;34(5):820-7. doi: 10.1097/00005768-200205000-00015.

    PMID: 11984301BACKGROUND

  • Shaibi GQ, Cruz ML, Ball GD, Weigensberg MJ, Salem GJ, Crespo NC, Goran MI. Effects of resistance training on insulin sensitivity in overweight Latino adolescent males. Med Sci Sports Exerc. 2006 Jul;38(7):1208-15. doi: 10.1249/01.mss.0000227304.88406.0f.

    PMID: 16826016BACKGROUND

  • Holten MK, Zacho M, Gaster M, Juel C, Wojtaszewski JF, Dela F. Strength training increases insulin-mediated glucose uptake, GLUT4 content, and insulin signaling in skeletal muscle in patients with type 2 diabetes. Diabetes. 2004 Feb;53(2):294-305. doi: 10.2337/diabetes.53.2.294.

    PMID: 14747278BACKGROUND

  • Bell LM, Watts K, Siafarikas A, Thompson A, Ratnam N, Bulsara M, Finn J, O'Driscoll G, Green DJ, Jones TW, Davis EA. Exercise alone reduces insulin resistance in obese children independently of changes in body composition. J Clin Endocrinol Metab. 2007 Nov;92(11):4230-5. doi: 10.1210/jc.2007-0779. Epub 2007 Aug 14.

    PMID: 17698905BACKGROUND

  • Moore DR, Del Bel NC, Nizi KI, Hartman JW, Tang JE, Armstrong D, Phillips SM. Resistance training reduces fasted- and fed-state leucine turnover and increases dietary nitrogen retention in previously untrained young men. J Nutr. 2007 Apr;137(4):985-91. doi: 10.1093/jn/137.4.985.

    PMID: 17374665BACKGROUND

  • Mascher H, Tannerstedt J, Brink-Elfegoun T, Ekblom B, Gustafsson T, Blomstrand E. Repeated resistance exercise training induces different changes in mRNA expression of MAFbx and MuRF-1 in human skeletal muscle. Am J Physiol Endocrinol Metab. 2008 Jan;294(1):E43-51. doi: 10.1152/ajpendo.00504.2007. Epub 2007 Oct 30.

    PMID: 17971512BACKGROUND

  • Ballor DL, Katch VL, Becque MD, Marks CR. Resistance weight training during caloric restriction enhances lean body weight maintenance. Am J Clin Nutr. 1988 Jan;47(1):19-25. doi: 10.1093/ajcn/47.1.19.

    PMID: 3337037BACKGROUND

  • Kraemer WJ, Volek JS, Clark KL, Gordon SE, Puhl SM, Koziris LP, McBride JM, Triplett-McBride NT, Putukian M, Newton RU, Hakkinen K, Bush JA, Sebastianelli WJ. Influence of exercise training on physiological and performance changes with weight loss in men. Med Sci Sports Exerc. 1999 Sep;31(9):1320-9. doi: 10.1097/00005768-199909000-00014.

    PMID: 10487375BACKGROUND

  • Faigenbaum AD, Kraemer WJ, Blimkie CJ, Jeffreys I, Micheli LJ, Nitka M, Rowland TW. Youth resistance training: updated position statement paper from the national strength and conditioning association. J Strength Cond Res. 2009 Aug;23(5 Suppl):S60-79. doi: 10.1519/JSC.0b013e31819df407.

    PMID: 19620931BACKGROUND

  • American Academy of Pediatrics Council on Sports Medicine and Fitness; McCambridge TM, Stricker PR. Strength training by children and adolescents. Pediatrics. 2008 Apr;121(4):835-40. doi: 10.1542/peds.2007-3790.

    PMID: 18381549BACKGROUND

  • Popkin BM. The nutrition transition: an overview of world patterns of change. Nutr Rev. 2004 Jul;62(7 Pt 2):S140-3. doi: 10.1111/j.1753-4887.2004.tb00084.x.

    PMID: 15387480BACKGROUND

  • Lopez P. Capítulo 1: Las enfermedades Cardiovasculares en los países subdesarrollados Bioquímica del endotelio vascular: Implicaciones fisiológicas y clínicas 2001. p. 21 - 34.

    BACKGROUND

  • Barker DJ, Meade TW, Fall CH, Lee A, Osmond C, Phipps K, Stirling Y. Relation of fetal and infant growth to plasma fibrinogen and factor VII concentrations in adult life. BMJ. 1992 Jan 18;304(6820):148-52. doi: 10.1136/bmj.304.6820.148.

    PMID: 1737158BACKGROUND

  • Victora CG, Adair L, Fall C, Hallal PC, Martorell R, Richter L, Sachdev HS; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: consequences for adult health and human capital. Lancet. 2008 Jan 26;371(9609):340-57. doi: 10.1016/S0140-6736(07)61692-4.

    PMID: 18206223BACKGROUND

  • Prentice AM, Moore SE. Early programming of adult diseases in resource poor countries. Arch Dis Child. 2005 Apr;90(4):429-32. doi: 10.1136/adc.2004.059030.

    PMID: 15781942BACKGROUND

  • Wright CM, Parker L, Lamont D, Craft AW. Implications of childhood obesity for adult health: findings from thousand families cohort study. BMJ. 2001 Dec 1;323(7324):1280-4. doi: 10.1136/bmj.323.7324.1280.

    PMID: 11731390BACKGROUND

  • Sawaya AL, Dallal G, Solymos G, de Sousa MH, Ventura ML, Roberts SB, Sigulem DM. Obesity and malnutrition in a Shantytown population in the city of Sao Paulo, Brazil. Obes Res. 1995 Sep;3 Suppl 2:107s-115s. doi: 10.1002/j.1550-8528.1995.tb00453.x.

    PMID: 8581766BACKGROUND

  • Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.

    PMID: 23746772BACKGROUND

  • Perez-Farinos N, Lopez-Sobaler AM, Dal Re MA, Villar C, Labrado E, Robledo T, Ortega RM. The ALADINO study: a national study of prevalence of overweight and obesity in Spanish children in 2011. Biomed Res Int. 2013;2013:163687. doi: 10.1155/2013/163687. Epub 2013 Sep 8.

    PMID: 24089663BACKGROUND

  • Touwslager RN, Gielen M, Tan FE, Mulder AL, Gerver WJ, Zimmermann LJ, Houben AJ, Zeegers MP, Derom C, Vlietinck R, Maes HH, Stehouwer CD, Thomis M. Genetic, maternal and placental factors in the association between birth weight and physical fitness: a longitudinal twin study. PLoS One. 2013 Oct 23;8(10):e76423. doi: 10.1371/journal.pone.0076423. eCollection 2013.

    PMID: 24194838BACKGROUND

  • Kuh D, Bassey J, Hardy R, Aihie Sayer A, Wadsworth M, Cooper C. Birth weight, childhood size, and muscle strength in adult life: evidence from a birth cohort study. Am J Epidemiol. 2002 Oct 1;156(7):627-33. doi: 10.1093/aje/kwf099.

    PMID: 12244031BACKGROUND

  • Inskip HM, Godfrey KM, Martin HJ, Simmonds SJ, Cooper C, Sayer AA; Southampton Women's Survey Study Group. Size at birth and its relation to muscle strength in young adult women. J Intern Med. 2007 Sep;262(3):368-74. doi: 10.1111/j.1365-2796.2007.01812.x.

    PMID: 17697158BACKGROUND

  • Ortega FB, Ruiz JR, Labayen I, Redondo C, Breidenassel C, Gomez S, Moreno LA, Castillo MJ; Avena Study Group. High fitness is associated with a healthier programming of body composition at adolescence. Am J Hum Biol. 2008 Nov-Dec;20(6):732-4. doi: 10.1002/ajhb.20813.

    PMID: 18770529BACKGROUND

  • Laaksonen DE, Lakka HM, Lynch J, Lakka TA, Niskanen L, Rauramaa R, Salonen JT, Kauhanen J. Cardiorespiratory fitness and vigorous leisure-time physical activity modify the association of small size at birth with the metabolic syndrome. Diabetes Care. 2003 Jul;26(7):2156-64. doi: 10.2337/diacare.26.7.2156.

    PMID: 12832329BACKGROUND

  • Ortega FB, Artero EG, Ruiz JR, Espana-Romero V, Jimenez-Pavon D, Vicente-Rodriguez G, Moreno LA, Manios Y, Beghin L, Ottevaere C, Ciarapica D, Sarri K, Dietrich S, Blair SN, Kersting M, Molnar D, Gonzalez-Gross M, Gutierrez A, Sjostrom M, Castillo MJ; HELENA study. Physical fitness levels among European adolescents: the HELENA study. Br J Sports Med. 2011 Jan;45(1):20-9. doi: 10.1136/bjsm.2009.062679. Epub 2009 Aug 20.

    PMID: 19700434BACKGROUND

  • Wells JC, Chomtho S, Fewtrell MS. Programming of body composition by early growth and nutrition. Proc Nutr Soc. 2007 Aug;66(3):423-34. doi: 10.1017/S0029665107005691.

    PMID: 17637095BACKGROUND

  • Eriksson M, Tynelius P, Rasmussen F. Associations of birthweight and infant growth with body composition at age 15--the COMPASS study. Paediatr Perinat Epidemiol. 2008 Jul;22(4):379-88. doi: 10.1111/j.1365-3016.2008.00944.x.

    PMID: 18578752BACKGROUND

  • Wells JC, Hallal PC, Wright A, Singhal A, Victora CG. Fetal, infant and childhood growth: relationships with body composition in Brazilian boys aged 9 years. Int J Obes (Lond). 2005 Oct;29(10):1192-8. doi: 10.1038/sj.ijo.0803054.

    PMID: 16103893BACKGROUND

  • Kelly LA, Lane CJ, Ball GD, Weigensberg MJ, Vargas LG, Byrd-Williams CE, Ventura EE, Goran MI. Birth weight and body composition in overweight Latino youth: a longitudinal analysis. Obesity (Silver Spring). 2008 Nov;16(11):2524-8. doi: 10.1038/oby.2008.401. Epub 2008 Sep 11.

    PMID: 18787529BACKGROUND

  • Sawaya AL, Martins P, Hoffman D, Roberts SB. The link between childhood undernutrition and risk of chronic diseases in adulthood: a case study of Brazil. Nutr Rev. 2003 May;61(5 Pt 1):168-75. doi: 10.1301/nr.2003.may.168-175.

    PMID: 12822705BACKGROUND

  • Yajnik CS, Fall CH, Coyaji KJ, Hirve SS, Rao S, Barker DJ, Joglekar C, Kellingray S. Neonatal anthropometry: the thin-fat Indian baby. The Pune Maternal Nutrition Study. Int J Obes Relat Metab Disord. 2003 Feb;27(2):173-80. doi: 10.1038/sj.ijo.802219.

    PMID: 12586996BACKGROUND

  • Sayer AA, Syddall HE, Gilbody HJ, Dennison EM, Cooper C. Does sarcopenia originate in early life? Findings from the Hertfordshire cohort study. J Gerontol A Biol Sci Med Sci. 2004 Sep;59(9):M930-4. doi: 10.1093/gerona/59.9.m930.

    PMID: 15472158BACKGROUND

  • Jackson AW, Lee DC, Sui X, Morrow JR Jr, Church TS, Maslow AL, Blair SN. Muscular strength is inversely related to prevalence and incidence of obesity in adult men. Obesity (Silver Spring). 2010 Oct;18(10):1988-95. doi: 10.1038/oby.2009.422. Epub 2009 Dec 3.

    PMID: 19960002BACKGROUND

  • Lazarus R, Sparrow D, Weiss ST. Handgrip strength and insulin levels: cross-sectional and prospective associations in the Normative Aging Study. Metabolism. 1997 Nov;46(11):1266-9. doi: 10.1016/s0026-0495(97)90228-6.

    PMID: 9361683BACKGROUND

  • Silventoinen K, Magnusson PK, Tynelius P, Batty GD, Rasmussen F. Association of body size and muscle strength with incidence of coronary heart disease and cerebrovascular diseases: a population-based cohort study of one million Swedish men. Int J Epidemiol. 2009 Feb;38(1):110-8. doi: 10.1093/ije/dyn231. Epub 2008 Nov 25.

    PMID: 19033357BACKGROUND

  • Ruiz JR, Sui X, Lobelo F, Lee DC, Morrow JR Jr, Jackson AW, Hebert JR, Matthews CE, Sjostrom M, Blair SN. Muscular strength and adiposity as predictors of adulthood cancer mortality in men. Cancer Epidemiol Biomarkers Prev. 2009 May;18(5):1468-76. doi: 10.1158/1055-9965.EPI-08-1075. Epub 2009 Apr 14.

    PMID: 19366909BACKGROUND

  • Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

    PMID: 20392703BACKGROUND

  • Jensen CB, Martin-Gronert MS, Storgaard H, Madsbad S, Vaag A, Ozanne SE. Altered PI3-kinase/Akt signalling in skeletal muscle of young men with low birth weight. PLoS One. 2008;3(11):e3738. doi: 10.1371/journal.pone.0003738. Epub 2008 Nov 17.

    PMID: 19011679BACKGROUND

  • Jensen CB, Storgaard H, Madsbad S, Richter EA, Vaag AA. Altered skeletal muscle fiber composition and size precede whole-body insulin resistance in young men with low birth weight. J Clin Endocrinol Metab. 2007 Apr;92(4):1530-4. doi: 10.1210/jc.2006-2360. Epub 2007 Feb 6.

    PMID: 17284623BACKGROUND

  • Ozanne SE, Jensen CB, Tingey KJ, Storgaard H, Madsbad S, Vaag AA. Low birthweight is associated with specific changes in muscle insulin-signalling protein expression. Diabetologia. 2005 Mar;48(3):547-52. doi: 10.1007/s00125-005-1669-7. Epub 2005 Feb 24.

    PMID: 15729577BACKGROUND

  • Scribbans TD, Edgett BA, Vorobej K, Mitchell AS, Joanisse SD, Matusiak JB, Parise G, Quadrilatero J, Gurd BJ. Fibre-specific responses to endurance and low volume high intensity interval training: striking similarities in acute and chronic adaptation. PLoS One. 2014 Jun 5;9(6):e98119. doi: 10.1371/journal.pone.0098119. eCollection 2014.

    PMID: 24901767BACKGROUND

  • Bruce CR, Anderson MJ, Carey AL, Newman DG, Bonen A, Kriketos AD, Cooney GJ, Hawley JA. Muscle oxidative capacity is a better predictor of insulin sensitivity than lipid status. J Clin Endocrinol Metab. 2003 Nov;88(11):5444-51. doi: 10.1210/jc.2003-030791.

    PMID: 14602787BACKGROUND

  • Olsson AH, Ronn T, Elgzyri T, Hansson O, Eriksson KF, Groop L, Vaag A, Poulsen P, Ling C. The expression of myosin heavy chain (MHC) genes in human skeletal muscle is related to metabolic characteristics involved in the pathogenesis of type 2 diabetes. Mol Genet Metab. 2011 Jul;103(3):275-81. doi: 10.1016/j.ymgme.2011.03.017. Epub 2011 Mar 21.

    PMID: 21470888BACKGROUND

  • Wade AJ, Marbut MM, Round JM. Muscle fibre type and aetiology of obesity. Lancet. 1990 Apr 7;335(8693):805-8. doi: 10.1016/0140-6736(90)90933-v.

    PMID: 1969558BACKGROUND

  • Tikkanen HO, Hamalainen E, Sarna S, Adlercreutz H, Harkonen M. Associations between skeletal muscle properties, physical fitness, physical activity and coronary heart disease risk factors in men. Atherosclerosis. 1998 Apr;137(2):377-89. doi: 10.1016/s0021-9150(97)00276-1.

    PMID: 9622281BACKGROUND

  • Frosig C, Richter EA. Improved insulin sensitivity after exercise: focus on insulin signaling. Obesity (Silver Spring). 2009 Dec;17 Suppl 3:S15-20. doi: 10.1038/oby.2009.383.

    PMID: 19927140BACKGROUND

  • Daugaard JR, Nielsen JN, Kristiansen S, Andersen JL, Hargreaves M, Richter EA. Fiber type-specific expression of GLUT4 in human skeletal muscle: influence of exercise training. Diabetes. 2000 Jul;49(7):1092-5. doi: 10.2337/diabetes.49.7.1092.

    PMID: 10909963BACKGROUND

  • Simoneau JA, Lortie G, Boulay MR, Marcotte M, Thibault MC, Bouchard C. Human skeletal muscle fiber type alteration with high-intensity intermittent training. Eur J Appl Physiol Occup Physiol. 1985;54(3):250-3. doi: 10.1007/BF00426141.

    PMID: 4065109BACKGROUND

  • Fry AC. The role of resistance exercise intensity on muscle fibre adaptations. Sports Med. 2004;34(10):663-79. doi: 10.2165/00007256-200434100-00004.

    PMID: 15335243BACKGROUND

  • Miller BF, Olesen JL, Hansen M, Dossing S, Crameri RM, Welling RJ, Langberg H, Flyvbjerg A, Kjaer M, Babraj JA, Smith K, Rennie MJ. Coordinated collagen and muscle protein synthesis in human patella tendon and quadriceps muscle after exercise. J Physiol. 2005 Sep 15;567(Pt 3):1021-33. doi: 10.1113/jphysiol.2005.093690. Epub 2005 Jul 7.

    PMID: 16002437BACKGROUND

  • Phillips SM, Tipton KD, Aarsland A, Wolf SE, Wolfe RR. Mixed muscle protein synthesis and breakdown after resistance exercise in humans. Am J Physiol. 1997 Jul;273(1 Pt 1):E99-107. doi: 10.1152/ajpendo.1997.273.1.E99.

    PMID: 9252485BACKGROUND

  • Petersen AM, Pedersen BK. The anti-inflammatory effect of exercise. J Appl Physiol (1985). 2005 Apr;98(4):1154-62. doi: 10.1152/japplphysiol.00164.2004.

    PMID: 15772055BACKGROUND

  • Shaibi GQ, Cruz ML, Weigensberg MJ, Toledo-Corral CM, Lane CJ, Kelly LA, Davis JN, Koebnick C, Ventura EE, Roberts CK, Goran MI. Adiponectin independently predicts metabolic syndrome in overweight Latino youth. J Clin Endocrinol Metab. 2007 May;92(5):1809-13. doi: 10.1210/jc.2006-2294. Epub 2007 Feb 20.

    PMID: 17311859BACKGROUND

  • Nappo A, Iacoviello L, Fraterman A, Gonzalez-Gil EM, Hadjigeorgiou C, Marild S, Molnar D, Moreno LA, Peplies J, Sioen I, Veidebaum T, Siani A, Russo P. High-sensitivity C-reactive protein is a predictive factor of adiposity in children: results of the identification and prevention of dietary- and lifestyle-induced health effects in children and infants (IDEFICS) study. J Am Heart Assoc. 2013 Jun 6;2(3):e000101. doi: 10.1161/JAHA.113.000101.

    PMID: 23744403BACKGROUND

  • Nazmi A, Victora CG. Socioeconomic and racial/ethnic differentials of C-reactive protein levels: a systematic review of population-based studies. BMC Public Health. 2007 Aug 17;7:212. doi: 10.1186/1471-2458-7-212.

    PMID: 17705867BACKGROUND

  • Ruiz JR, Ortega FB, Warnberg J, Moreno LA, Carrero JJ, Gonzalez-Gross M, Marcos A, Gutierrez A, Sjostrom M. Inflammatory proteins and muscle strength in adolescents: the Avena study. Arch Pediatr Adolesc Med. 2008 May;162(5):462-8. doi: 10.1001/archpedi.162.5.462.

    PMID: 18458193BACKGROUND

  • Donges CE, Duffield R, Drinkwater EJ. Effects of resistance or aerobic exercise training on interleukin-6, C-reactive protein, and body composition. Med Sci Sports Exerc. 2010 Feb;42(2):304-13. doi: 10.1249/MSS.0b013e3181b117ca.

    PMID: 20083961BACKGROUND

  • Daray LA, Henagan TM, Zanovec M, Earnest CP, Johnson LG, Winchester J, Tuuri G, Stewart LK. Endurance and resistance training lowers C-reactive protein in young, healthy females. Appl Physiol Nutr Metab. 2011 Oct;36(5):660-70. doi: 10.1139/h11-077. Epub 2011 Oct 4.

    PMID: 21970447BACKGROUND

  • Kamal NN, Ragy MM. The effects of exercise on C-reactive protein, insulin, leptin and some cardiometabolic risk factors in Egyptian children with or without metabolic syndrome. Diabetol Metab Syndr. 2012 Jun 12;4(1):27. doi: 10.1186/1758-5996-4-27.

    PMID: 22691465BACKGROUND

  • Nassis GP, Papantakou K, Skenderi K, Triandafillopoulou M, Kavouras SA, Yannakoulia M, Chrousos GP, Sidossis LS. Aerobic exercise training improves insulin sensitivity without changes in body weight, body fat, adiponectin, and inflammatory markers in overweight and obese girls. Metabolism. 2005 Nov;54(11):1472-9. doi: 10.1016/j.metabol.2005.05.013.

    PMID: 16253636BACKGROUND

  • Artero EG, Lee DC, Lavie CJ, Espana-Romero V, Sui X, Church TS, Blair SN. Effects of muscular strength on cardiovascular risk factors and prognosis. J Cardiopulm Rehabil Prev. 2012 Nov-Dec;32(6):351-8. doi: 10.1097/HCR.0b013e3182642688.

    PMID: 22885613BACKGROUND

  • Lopez-Jaramillo P, Cohen DD, Gomez-Arbelaez D, Bosch J, Dyal L, Yusuf S, Gerstein HC; ORIGIN Trial Investigators. Association of handgrip strength to cardiovascular mortality in pre-diabetic and diabetic patients: a subanalysis of the ORIGIN trial. Int J Cardiol. 2014 Jun 15;174(2):458-61. doi: 10.1016/j.ijcard.2014.04.013. Epub 2014 Apr 13. No abstract available.

    PMID: 24768457BACKGROUND

  • van Deutekom AW, Chinapaw MJ, Vrijkotte TG, Gemke RJ. Study protocol: the relation of birth weight and infant growth trajectories with physical fitness, physical activity and sedentary behavior at 8-9 years of age - the ABCD study. BMC Pediatr. 2013 Jul 9;13:102. doi: 10.1186/1471-2431-13-102.

    PMID: 23835159BACKGROUND

  • 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.

    PMID: 21050079BACKGROUND

  • 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.

    PMID: 18628517BACKGROUND

  • Batería ALPHA-Fitness: Test de campo para la evaluación de la condición física relacionada con la salud en niños y adolescentes.Pag 21

    BACKGROUND

  • 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.

    PMID: 20426223BACKGROUND

  • 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.

    PMID: 20178516BACKGROUND

  • 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.

    PMID: 19268640BACKGROUND

  • RICKE O, SCHOENAU E ibid Pag 228

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 12032755BACKGROUND

  • 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.

    PMID: 21509084BACKGROUND

Study Officials

  • PATRICIO LOPEZ, JARAMILLO

    FUNDACION OFTALMOLOGICA DE SANTANDER

    STUDY DIRECTOR

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

Study Record Dates

First Submitted

September 28, 2017

First Posted

December 19, 2018

Study Start

February 1, 2016

Primary Completion

July 30, 2016

Study Completion

December 10, 2016

Last Updated

December 27, 2018

Record last verified: 2018-12