Aerobic Physical Training and Heart Rate Variability in Hypertersion

Not Applicable

Completed

• Conditions: Autonomic Nervous System Diseases
• Interventions: Behavioral: Physical training program

• Registration Number: NCT03064256
• Lead Sponsor: University of Campinas, Brazil

Brief 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.

Detailed 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 Timeline

• Study Start: 2014-11-14
• Primary Completion: 2015-12-21
• Study Completion: 2017-01-16
• Status Verified: 2017-02
• Study First Submitted: 2017-02-19
• Study First Submitted QC: 2017-02-21
• Last Update Submitted: 2017-02-21
• Study First Posted: 2017-02-27
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• SBP ≤ 180 mmHg and DBP ≤ 110 mmHg)
• low risk for physical training.

Exclusion Criteria

• obesity III
• musculoskeletal conditions
• peripheral neuropathy
• Parkinson's disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical training program	Physical training program	Intervention participants are submitted to supervised aerobic physical training at the predetermined intensity, which is composed of three weekly sessions, lasting one hour, over a period of 12 weeks. All sessions were started with stretches for lower and upper limbs lasting 10 minutes for warm-up, and after trekking on treadmill using the predetermined critical velocity (Vcrit). The exercises were completed with cooling of the muscle groups for one minute still on the treadmill, plus 10 minutes of relaxation exercises on the mat at the end of aerobic exercise.

Primary Outcome Measures

Name	Time	Method
Heart rate variability will be measured by nonlinear methods in hypertensive patients to observe changes in baseline values after 12 weeks.	Finalized study (12 weeks)	A heart rate meter RS800CX (Polar Electro Co.Ltda. Kempele, Finland) is used to obtain HR and R-R (iR-R) intervals. The iR-Rs are captured from a tape with a coded transmitter placed in the chest region at the 5th intercostal space and transmitted to the cardiofrequency meter where they are recorded

Secondary Outcome Measures

Name	Time	Method
The peak oxygen consumption (mL / kg · min) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.	Finalized study (12 weeks)	Cardiopulmonary exercise test used to determine peak oxygen consumption to exercise .
The double product (mmHg) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.	Finalized study (12 weeks)	Cardiopulmonary exercise test used to determine double produc to exercise .
The oxigen pulse (ml/heart rate) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.	Finalized study (12 weeks)	Cardiopulmonary exercise test used to determine oxigen pulse to exercise .