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Exercise Training Associated With Inspiratory Muscle Training in Heart Failure

This study is currently recruiting participants.
Verified May 2017 by Patricia Fernandes Trevizan, University of Sao Paulo General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01747395
First Posted: December 11, 2012
Last Update Posted: May 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Patricia Fernandes Trevizan, University of Sao Paulo General Hospital
  Purpose
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.

Condition Intervention
Heart Failure Other: Exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Aerobic Exercise Training Associated With Inspiratory Muscle Training in Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by Patricia Fernandes Trevizan, University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Autonomic control [ Time Frame: 4 months ]
    Exercise training associated with inspiratory muscle training will reduce sympathetic nerve activity.


Secondary Outcome Measures:
  • Functional Capacity [ Time Frame: 4 months ]
    Exercise training associated with inspiratory muscle training will improve peak oxygen consumption

  • Quality of life [ Time Frame: 4 months ]
    Exercise training associated with inspiratory muscle training will improve quality of life

  • Blood inflammatory markers [ Time Frame: 4 months ]
    Exercise training associated with inspiratory muscle training will reduces blood inflammatory markers

  • Muscular evaluation [ Time Frame: 4 months ]
    Exercise training associated with inspiratory muscle training will increase skeletal muscle strength

  • Respiratoy muscle function [ Time Frame: 4 months ]
    Exercise training associated with inspiratory muscle training will increase inspitarory muscle strength and endurance.


Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: December 2017
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747395


Contacts
Contact: Carlos Eduardo Negrão 21 11 26615699 cndnegrao@incor.usp.br
Contact: Patricia Fernandes Trevizan 21 11 2661 5099 patricia_trevizan@yahoo.com.br

Locations
Brazil
Instituto do Coração - HC/FMUSP Recruiting
São Paulo, SP, Brazil
Contact: Patricia Trevizan    21 11 2661 5099    patricia_trevizan@yahoo.com.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Federal University of São Paulo
Investigators
Principal Investigator: Carlos Eduardo Negrão InCor, HCFMUSP
  More Information

Responsible Party: Patricia Fernandes Trevizan, BS, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01747395     History of Changes
Other Study ID Numbers: ICRESP814/10
First Submitted: December 6, 2012
First Posted: December 11, 2012
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Patricia Fernandes Trevizan, University of Sao Paulo General Hospital:
Heart Failure
Exercise and Physical Fitness

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases