Aerobic Physical Training and Heart Rate Variability in Hypertersion

NCT03064256 | Completed DMC

• 1 other identifier: 865.096
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autonomic Nervous System Diseases

Keywords

Exercisy therapy; Hypertension; Physiopathology; Heart rate; Nonlinear dynamics

Outcome Measures

Primary Outcomes (1)

• Heart rate variability will be measured by nonlinear methods in hypertensive patients to observe changes in baseline values after 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

  Finalized study (12 weeks)

Secondary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

Physical training program

EXPERIMENTAL

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.

Behavioral: Physical training program

Control Group

NO INTERVENTION

Control participants receive routine outpatient care for a 12-week period.

Interventions

Physical training program BEHAVIORAL

Physical training program consisted of three weekly sessions lasting up to one hour over a period of twelve weeks. and will be carried out respecting the traditional training principles: biological individuality, Specificity, overload, adaptation and reversibility

Physical training program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Medical Outpatient Vlinic of the Government of the State of São Paulo: collaborator

MeSH Terms

Conditions

Autonomic Nervous System Diseases; Hypertension

Condition Hierarchy (Ancestors)

Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: February 19, 2017
• First Posted: February 27, 2017
• Study Start: November 14, 2014
• Primary Completion: December 21, 2015
• Study Completion: January 16, 2017
• Last Updated: February 27, 2017

Record last verified: 2017-02