Exercise Training Associated With Inspiratory Muscle Training in Heart Failure

April 27, 2021 updated by: Patricia Fernandes Trevizan, University of Sao Paulo General Hospital

Effects of Aerobic Exercise Training Associated With Inspiratory Muscle Training in Patients With Heart Failure

The investigators hypothesize that aerobic exercise training associated with respiratory muscle training will cause additional benefits compared to isolated exercise training or respiratory training in chronic heart failure patients.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators hypothesize that aerobic exercise training associated with respiratory muscle training will cause additional benefits in the autonomic control and respiratory function compared to isolated exercise training or respiratory training in chronic heart failure patients.

Study Type

Interventional

Enrollment (Anticipated)

40

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
    • SP
      • São Paulo, SP, Brazil
        • Instituto do coração - HC/FMUSP

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 systolic heart failure and New York Heart Association (NYHA) class II-III
  • Left ventricular ejection fraction less than 40%
  • Peak Oxygen Consumption less than 20 ml/Kg/min

Exclusion Criteria:

  • Chronic Obstructive Pulmonary Disease
  • Neuromuscular, Orthopedic, Neurologic and Neoplastic Diseases
  • Recent myocardial infarction or cardiac surgery (less than 6 months)
  • Unstable angina pectoris
  • Atrial Fibrillation
  • Pacemakers users
  • Actual Smoker
  • Pregnant
  • 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: Control Group
No exercise group (sedentary)
Experimental: Aerobic Exercise Training
Group undergoing isolate aerobic exercise training 3 times/week, during 40 minutes, for 04 mouths
Other: Exercise training
The heart failure patients are subjected to differents protocols of physical training
Experimental: Inspiratory Muscle Training
Group undergoing isolate inspiratory muscle training 7 times/week, during 30 minutes, for 04 mouths
Other: Exercise training
The heart failure patients are subjected to differents protocols of physical training
Experimental: Aerobic+Inspiratory Muscle Training
Group undergoing aerobic exercise training (3 times/week during 40 minutes) associate inspiratory muscle training (7 times/week during 30 minutes) for 04 mounths
Other: Exercise training
The heart failure patients are subjected to differents protocols of physical training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autonomic control
Time Frame: 4 months
Exercise training associated with inspiratory muscle training will reduce sympathetic nerve activity.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Capacity
Time Frame: 4 months
Exercise training associated with inspiratory muscle training will improve peak oxygen consumption
4 months
Quality of life
Time Frame: 4 months
Exercise training associated with inspiratory muscle training will improve quality of life
4 months
Blood inflammatory markers
Time Frame: 4 months
Exercise training associated with inspiratory muscle training will reduces blood inflammatory markers
4 months
Muscular evaluation
Time Frame: 4 months
Exercise training associated with inspiratory muscle training will increase skeletal muscle strength
4 months
Respiratoy muscle function
Time Frame: 4 months
Exercise training associated with inspiratory muscle training will increase inspitarory muscle strength and endurance.
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

Federal University of São Paulo

Investigators

  • Principal Investigator: Carlos Eduardo Negrão, InCor, HCFMUSP

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

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, 2012

Primary Completion (Actual)

April 1, 2020

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

December 6, 2012

First Submitted That Met QC Criteria

December 7, 2012

First Posted (Estimate)

December 11, 2012

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICRESP814/10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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