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Clinical Trial Summary

This study compared the changes in the cardiovascular, hemodynamic and metabolic variables of hypertensive patients who received aerobic physical training with intensity determined by the protocol of double non-exhaustive efforts (DENE) with that of patients who received routine outpatient care 12 weeks after Entry into the study. 63 men and women participated in the study and were allocated in the intervention group (n = 42) and control group (n = 21).The following were performed: Cardiopulmonary exercise test (TECP) for evaluation of peak oxygen consumption (VO2peak), oxygen pulse and double product; DENE protocol for the determination of the intensity of the training. It was obtained the recording of the intervals between consecutive heart beats (iRR) to evaluate the autonomic modulation of the heart rate. Body mass index, waist circumference (AC), hip circumference (CQ) and Waist / hip ratio (WHR) were measured.


Clinical Trial Description

The study was designed to compare changes in the cardiovascular, hemodynamic and metabolic variables of hypertensive patients who received aerobic physical training with intensity determined by the DENE protocol with that of patients who received routine ambulatory care 12 weeks after entering the study.

Sixty-three hypertensive men and women, divided into the intervention group (GI) (n=42) and the control group (n = 21) participated in the study.

All procedures were performed by trained researchers and qualified staff and the evaluations and intervention were performed at the specialty medical outpatient clinic.

After agreeing to participate in the study, we collected sociodemographic and clinical data, body mass index (BMI), waist circumference (WC) and waist / hip ratio (WHR). The participants were submitted to the cardiopulmonary exercise test (TECP), to evaluate the peak oxygen consumption (VO2peak), oxygen pulse and double product. Between one and seven days after TECP, consecutive heart rate intervals (iRR) were recorded for evaluation of autonomic heart rate modulation using a Polar model RS800CX (Polar Electro Co.Ltda Kempele, Finland). . The DENE protocol for determining the intensity of the training was applied in the GI to determine the training intensity in the treadmill. Intervention participants underwent supervised aerobic physical training at the pre-determined intensity, which consisted of three weekly sessions, lasting one hour, over a period of 12 weeks. Control participants receive routine care from the outpatient clinic for the same period. At the end of the 12 weeks, measures, recording of the iRR intervals, oxygen pulse, double product, BMI, waist circumference (AC), hip circumference (QC) and waist / hip ratio (WHR) were obtained. All subjects were previously informed about the procedures Signed a free and informed consent form. The project was approved by the Commission of Research Committee of the Institution with the number 086.096 / 14. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03064256
Study type Interventional
Source University of Campinas, Brazil
Contact
Status Completed
Phase N/A
Start date November 14, 2014
Completion date January 16, 2017

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