Muscular Strength and Aerobic Capacity, a Symbiotic Relationship With Birth Weight and Metabolic Risk of Colombian Scholchildren: Study SIMAC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 主要终点
- % of change in the lipid profile levels within the experimental groups with the habitual training
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 12 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
% of change in the lipid profile levels within the experimental groups with the habitual training
时间窗: Twelve months
Evaluation of cardiometabolic risk factors related to physical training to take into account in patients with a risk of developing cardiometabolic diseases and that have as antecedents low birth weight to identify them and prevent the appearance of these pathologies that affect the health and quality of life
% of change in the glucose levels within the experimental groups with the habitual training
时间窗: Twelve months
Evaluation of cardiometabolic risk factors related to physical training to take into account in patients with a risk of developing cardiometabolic diseases and that have as antecedents low birth weight to identify them and prevent the appearance of these pathologies that affect the health and quality of life
% of change in the body mass index within the experimental groups with the habitual training
时间窗: Twelve months
Evaluation of cardiometabolic risk factors related to physical training to take into account in patients with a risk of developing cardiometabolic diseases and that have as antecedents low birth weight to identify them and prevent the appearance of these pathologies that affect the health and quality of life
次要结局
- % 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)
研究者
Paul Anthony Camacho Lopez
Principal Investigator
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
