Exercise Improve Sympathetic Modulation in Chronic Heart Failure Patients

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219451
• Other study ID #: sympathetic modulation
• Status: Completed
• Phase: Phase 4
• First received: August 4, 2014
• Last updated: August 18, 2014
• Start date: August 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Other:
• exercise training
exercise training

Locations

Country	Name	City	State
Brazil	Instituto do Coração - HC/FMUSP	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	InCor Heart Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autonomic control	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	No
Secondary	Arterial baroreflex control	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	No