Aerobic Training on the Autonomic Modulation in Children

Study Overview
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Brief Summary
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The heart rate variability is a tool used to asses non-invasive cardiac autonomic. In fact, many studies have been disseminated of heart rate variability in adults, however few results in a literature this parameters in pediatric population, mainly with children submitted the physical training. Thus, this Project aims to verify the effects of aerobic training, with 10 weeks, in prepubertal on the performance and heart rate variability in rest.

Detailed Description
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The randomized control trial in accordance with Consort - Statement (Moher et al., 2012) will be done. Will be included 160 children, 80 in an experimental group and 80 children with no intervention, of both genders.

Official Title
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The Effects of 10 Weeks of Aerobic Training on the Autonomic Modulation in Prepubertal Children: a Randomized Control Trial

Conditions
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Healthy

Intervention / Treatment
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* Other: Aerobic Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children be with body weight and height between the 10th and 90th percentiles, according to criteria adopted by the Centers for Disease Control and Prevention (CDC, 2002). To characterize the infant state, all volunteers will conduct evaluation of secondary sexual characters by criteria of Tanner (Marshall and Tanner, 1970), through visual inspection by a single experienced paediatrician. Children must show the initial stage of pubertal development, for girls (1 breast) and boys (genital 1) to be included and characterized such prepubertal. Participants throughout the trial entering puberty will be excluded from the final analysis. The children will be healthy, without clinical or historical evidence of cardiovascular disease, hypertension, insulin-dependent diabetes mellitus or obesity, and were not taking any drugs. Exclusion Criteria: The participants can be not linked to sports practices at least one year before the beginning the study, and can be involved only with the physical education classes two times a week for 50 minutes each class.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: Aerobic Training<br>The children included in the experimental group will make 10 weeks of aerobic training. The intensity of the race will be based on individual speed obtained in the last stage completed the progressive test, known as the maximal aerobic speed (MAV) in km/h. The running speed of the exercise protocol will be minimum 80% of the MAV in the protocol of continuous training. The intermittent progressive training is n * (10*15 s) to 100% MAV, and n from 2 to 6 series between the first and tenth week. The training protocol was adapted from previously described (Mandigout et al, 2002, Gamelin et al, 2009.). Acceptance of the exercise in a pediatric population has been previously observed by pilot study. | Other: Aerobic Training<br>* Will be included 160 children, 80 in an experimental group and 80 in a control group of both genders. The experimental group will realize aerobic training during 10 weeks (3×40min week-1; intensity, >80% maximal aerobic velocity - MAV), while the control group will have involved with the physical education classes two times a week for 50 minutes each class. The aerobic protocol will be composed by 2 sessions of intermittent running and 1 session by continuous.<br>|
| No Intervention: physical education classes<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rest Heart Rate Variability in short term | The cardiac autonomic modulation of the sinoatrial node will be estimated via heart rate variability (HRV) pre- after 5 weeks - post-10 weeks of training and after 8 weeks of finished the intervention (follow-up period). The duration of the RR interval recordings (RRinterval) will be obtained from each children using a portable heart rate monitor (Polar RS800) at a sampling rate of 1000 Hz. The recordings will be downloaded via commercial software and export for later analysis of time and frequency domain measures of HRV. The time domain indices examined will be: the mean RR interval, the root-mean-square difference of successive normal RR intervals (RMSSD), which reflects vagal modulation, and the standard deviation of all normal RR intervals (SDNN), which comprises both sympathetic and vagal cardiac modulations (Task Force, 1996). | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart rate variability, children, progressive test