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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aerobic Exercise Training
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Heart Institute (InCor), University of Sao Paulo Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Heart Failure Untrained Group

Heart Failure Exercise-trained Group

Arm Description

Control Group

Aerobic Exercise Training

Outcomes

Primary Outcome Measures

Autonomic Control
Mechanoreceptors were activated by passive exercise and metaboreceptors by post-exercise circulatory arrest
Muscular Evaluation
Muscular evaluation will be done by muscle gene expression

Secondary Outcome Measures

Functional Capacity
Functional Capacity will be determined by cardiopulmonary exercise testing
Muscle Blood Flow
Forearm blood flow will be assessed by venous occlusion plethysmography
Blood Pressure
Blood pressure will be monitored non-invasively

Full Information

First Posted
March 27, 2013
Last Updated
April 26, 2021
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
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1. Study Identification

Unique Protocol Identification Number
NCT01884142
Brief Title
Effects of Exercise Training on Mechanoreflex and Metaboreflex Control in Heart Failure Patients
Official Title
Effects of Exercise Training on Mechanoreflex and Metaboreflex Control of Muscle Sympathetic Nerve Activity in Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 2008 (Actual)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heart Failure Untrained Group
Arm Type
No Intervention
Arm Description
Control Group
Arm Title
Heart Failure Exercise-trained Group
Arm Type
Experimental
Arm Description
Aerobic Exercise Training
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise Training
Primary Outcome Measure Information:
Title
Autonomic Control
Description
Mechanoreceptors were activated by passive exercise and metaboreceptors by post-exercise circulatory arrest
Time Frame
4 months
Title
Muscular Evaluation
Description
Muscular evaluation will be done by muscle gene expression
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Functional Capacity
Description
Functional Capacity will be determined by cardiopulmonary exercise testing
Time Frame
4 months
Title
Muscle Blood Flow
Description
Forearm blood flow will be assessed by venous occlusion plethysmography
Time Frame
4 months
Title
Blood Pressure
Description
Blood pressure will be monitored non-invasively
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos E Negrão, PhD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute (InCor), University of Sao Paulo Medical School
City
Sao Paulo
ZIP/Postal Code
05403-904
Country
Brazil

12. IPD Sharing Statement

Citations:
Citation
Unable to connect to PubMed to validate , last attempt on June 19, 2013 at 12:03 PM EDT
Results Reference
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Effects of Exercise Training on Mechanoreflex and Metaboreflex Control in Heart Failure Patients

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