Exercise Improve Sympathetic Modulation in Chronic Heart Failure Patients

Phase 4

Completed

• Conditions: Chronic Heart Failure
• Interventions: Other: exercise training

• Registration Number: NCT02219451
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2013-08
• Primary Completion: 2014-04
• Study Completion: 2014-07
• Status Verified: 2014-08
• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-08-18
• Last Update Submitted: 2014-08-18
• Study First Posted: 2014-08-19
• Last Update Posted: 2014-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Autonomic control	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

Secondary Outcome Measures

Name	Time	Method
Arterial baroreflex control	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.

Trial Locations

Locations (1)

Instituto do Coração - HC/FMUSP; 🇧🇷 Sao Paulo, Brazil