Aerobic Training on the Autonomic Modulation in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02236117|
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : May 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: Aerobic Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effects of 10 Weeks of Aerobic Training on the Autonomic Modulation in Prepubertal Children: a Randomized Control Trial|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||February 2017|
Experimental: Intervention: Aerobic Training
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
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.
|No Intervention: physical education classes|
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236117
|Universidade Estadual de Londrina|
|Londrina, Paraná, Brazil, 86057-970|
|Principal Investigator:||Carla Silva, Doctor||Universidade Estadual de Londrina|