Effects of Exercise Training on Mechanoreflex and Metaboreflex Control in Heart Failure Patients

April 26, 2021 updated by: Lígia M. Antunes-Correa, University of Sao Paulo General Hospital

Effects of Exercise Training on Mechanoreflex and Metaboreflex Control of Muscle Sympathetic Nerve Activity in Heart Failure Patients

The investigators hypothesize that exercise training would improve the mechanoreflex and metaboreflex control in heart failure patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

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

  • Brazil
      • Sao Paulo, Brazil, 05403-904
        • Heart Institute (InCor), University of Sao Paulo Medical School

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with systolic heart failure;
  • New York Heart Association (NYHA) class II-III;
  • Left ventricular ejection fraction less than 40%;
  • Peak Oxygen Consumption less than 20 ml/Kg/min;
  • Stable Clinical Status.

Exclusion Criteria:

  • Chronic Obstructive Pulmonary Disease;
  • Neuromuscular Diseases;
  • Orthopedic Diseases;
  • Neurologic Diseases;
  • Neoplastic Diseases;
  • Recent myocardial infarction or cardiac surgery (less than 6 months);
  • Unstable angina pectoris;
  • Atrial Fibrillation;
  • Pacemakers users;
  • Changing medication or hospital admission.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Heart Failure Untrained Group
Control Group
Experimental: Heart Failure Exercise-trained Group
Aerobic Exercise Training
Other: Aerobic Exercise Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autonomic Control
Time Frame: 4 months
Mechanoreceptors were activated by passive exercise and metaboreceptors by post-exercise circulatory arrest
4 months
Muscular Evaluation
Time Frame: 4 months
Muscular evaluation will be done by muscle gene expression
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Blood Flow
Time Frame: 4 months
Forearm blood flow will be assessed by venous occlusion plethysmography
4 months
Functional Capacity
Time Frame: 4 months
Functional Capacity will be determined by cardiopulmonary exercise testing
4 months
Blood Pressure
Time Frame: 4 months
Blood pressure will be monitored non-invasively
4 months

Collaborators and Investigators

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

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Carlos E Negrão, PhD, University of Sao Paulo General Hospital

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.

General Publications

  • Unable to connect to PubMed to validate , last attempt on June 19, 2013 at 12:03 PM EDT

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 (Actual)

March 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 27, 2013

First Submitted That Met QC Criteria

June 19, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ergoreflex

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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