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Clinical Trials/NCT02236117
NCT02236117
Completed
Not Applicable

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

Universidade Estadual de Londrina1 site in 1 country160 target enrollmentSeptember 2015
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Universidade Estadual de Londrina
Enrollment
160
Locations
1
Primary Endpoint
Rest Heart Rate Variability in short term
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
February 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carla Cristiane da Silva

The Effects of 10 weeks of aerobic training on the autonomic modulation in prepubertal children: a randomized control trial

Universidade Estadual de Londrina

Eligibility Criteria

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.

Outcomes

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).

Study Sites (1)

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