Exercise Improve Sympathetic Modulation in Chronic Heart Failure Patients

August 18, 2014 updated by: Raphaela Vilar Ramalho Groehs, University of Sao Paulo General Hospital

Exercise Training Improves Oscillatory Pattern and Arterial Baroreflex Control of Sympathetic Nerve Activity in Patients With Chronic Heart Failure

The purpose of this study is to verify the effects of exercise training on sympathetic modulation and arterial baroreflex control in patients with chronic heart failure.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Retrospective study. Patients were recruited by database from Rehabilitation Unit of Cardiovascular Rehabilitation and Exercise Physiology of the Heart Institute (InCor). The aim of this study is to assess the effects of exercise training on sympathetic modulation and arterial baroreflex control in patients with chronic heart failure. The investigators studied twenty-six chronic heart failure outpatients, age 30 to 70 years, functional class II to III of New York Heart Association, left ventricular ejection fraction (LVEF) ≤40% and peak oxygen uptake (VO2) ≤20. The exclusion criteria were recent myocardial infarction or unstable angina (<3 months), heart failure duration (<3 months), permanent pacemaker dependence, atrial fibrillation, skeletal muscle abnormality (e.g., arthritis) and participation in a regular exercise program. They were assigned to 2 groups: Untrained (n=13) and trained (n=13).

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sao Paulo, Brazil, 05403-900
        • Instituto do coração - HC/FMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with chronic heart failure
  • Age 30 to 70 years
  • Functional class II to III of New York Heart Association
  • Left ventricular ejection fraction (LVEF) ≤40%
  • Peak oxygen uptake (VO2) ≤20

Exclusion Criteria:

  • Recent myocardial infarction or unstable angina (<3 months)
  • heart failure duration (<3 months)
  • Permanent pacemaker dependence
  • Atrial fibrillation
  • Skeletal muscle abnormality (e.g., arthritis)
  • Participation in a regular exercise program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: exercise training
We studied twenty-six chronic heart failure outpatients and they were assigned to 2 groups: Untrained (n=13) and trained (n=13).
exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autonomic control
Time Frame: 4 months
To asses the effects of exercise training on sympathetic modulation by analyze of autonomic control in chronic heart failure patients after 4 months protocol.Time series of muscle sympathetic nerve activity and systolic arterial pressure were analyzed by autoregressive spectral analysis
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial baroreflex control
Time Frame: 4 months
To asses the effects of exercise training on arterial baroreflex by analyze of arterial baroreflex control in chronic heart failure patients after 4 months. The arterial baroreflex control was analyzed by bivariate autoregressive.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Heart Institute HC/FMUSP, HC/FMUSP, Heart Institute, University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

August 4, 2014

First Submitted That Met QC Criteria

August 18, 2014

First Posted (Estimate)

August 19, 2014

Study Record Updates

Last Update Posted (Estimate)

August 19, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sympathetic modulation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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