- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02219451
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
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
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Sao Paulo, Brazil, 05403-900
- Instituto do coração - HC/FMUSP
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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).
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exercise training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Autonomic control
Time Frame: 4 months
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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
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4 months
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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.
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4 months
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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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