Aerobic Training on the Autonomic Modulation in Children

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236117
• Other study ID #: CONEP 5231
• Status: Completed
• Phase: N/A
• First received: August 25, 2014
• Last updated: May 17, 2017
• Start date: September 2015
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: Universidade Estadual de Londrina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Aerobic Training
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.

Locations

Country	Name	City	State
Brazil	Universidade Estadual de Londrina	Londrina	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual de Londrina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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