Aerobic Training on the Autonomic Modulation in Children

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

7 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Estadual de Londrina

Londrina, Paraná, 86057-970, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic training

Other

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.

Primary outcomes

Rest Heart Rate Variability in short term

Time frame: 10 weeks

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).

Sponsors and collaborators

Lead sponsor

Universidade Estadual de Londrina

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: Sep 10, 2014
Registry last updated: May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed