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Resistance TrainingSIMACNCT03779737

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

A study testing Muscular Resistance training, Cardiorespiratory training and Habitual training in people with Resistance Training and Cardiovascular Risk, run by Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 17 yearsHealthy volunteers can take part
What is being tested?
Muscular Resistance training, Cardiorespiratory training and Habitual training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
No sites listed yet
Study dates
1 Feb 2016to 10 Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

About this study

Official title: Muscular Strength and Aerobic Capacity, a Symbiotic Relationship With Birth Weight and Metabolic Risk of Colombian Scholchildren: Study SIMAC

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.

Read more

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.

Read the detailed description

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.

Being tested
Muscular Resistance training, Cardiorespiratory training, Habitual training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Muscular Resistance trainingBehavioural

  • Cardiorespiratory trainingBehavioural

  • Habitual trainingBehavioural

Study groups in NCT03779737
Study groupRoleWhat they receive
Habitual trainingActive comparatorThe control group will be monitored passively for the detection of adverse or secondary events.
Receives: Behavioral: Muscular Resistance training; Behavioral: Cardiorespiratory training
Muscular resistance trainingExperimentalThis 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.
Receives: Behavioral: Habitual training
Cardiorespiratory trainingExperimentalIn 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.
Receives: Behavioral: Habitual training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. % 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

    Measured: Twelve months

  2. % 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

    Measured: Twelve months

  3. % 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

    Measured: Twelve months

Secondary outcomes (3)
  1. % change in the hand grip strenght test within the experimental groups with the habitual training

    % 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)

    Measured: Twelve months

  2. % change in the flexibility within the experimental groups with the habitual training

    % 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)

    Measured: Twelve months

  3. % change in the vertical jump within the experimental groups with the habitual training

    % 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)

    Measured: Twelve months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2018
  2. Study start1 Feb 2016
  3. Primary completion30 Jul 2016
  4. Study completion10 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03779737
Sponsor's protocol ID
651765741093
Acronym
SIMAC
Status last verified
Dec 2018
First submitted
28 Sep 2017
Last updated
27 Dec 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 24714401
  • 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.

    PubMed 14600186
  • 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.

    PubMed 19480763
  • 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.

    PubMed 19516166
  • 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.

    PubMed 18698226
  • 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/.

  • 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.

    PubMed 17907329
  • 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.

    PubMed 21406494
  • 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.

    PubMed 18645341
  • 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.

  • 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.

    PubMed 15364185
  • 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.

    PubMed 17339564
  • 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.

    PubMed 24514426
  • 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-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.

    PubMed 18437144

Questions about this trial

What is this clinical trial studying?

A study testing Muscular Resistance training, Cardiorespiratory training and Habitual training in people with Resistance Training and Cardiovascular Risk, run by Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% of change in the glucose levels within the experimental groups with the habitual training (time frame: Twelve months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03779737, which also lists 93 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2018.

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