Exercise Training Associated With Inspiratory Muscle Training in Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Sao Paulo General Hospital
Sponsor:
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Patricia Fernandes Trevizan, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01747395
First received: December 6, 2012
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Heart Failure
Other: Physical exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Autonomic control [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Exercise training associated with inspiratory muscle training will reduce sympathetic nerve activity.

  • Respiratory function [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Exercise training associated with inspiratory muscle training will improve respiratory muscle strength and resistance.


Secondary Outcome Measures:
  • Functional Capacity [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Exercise training associated with inspiratory muscle training will improve peak oxygen consumption

  • Quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Exercise training associated with inspiratory muscle training will improve quality of life

  • Blood inflammatory markers [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Exercise training associated with inspiratory muscle training will reduces blood inflammatory markers

  • Muscular evaluation [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Exercise training associated with inspiratory muscle training will increase skeletal muscle strength


Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
Experimental: Aerobic Exercise Training
Isolate Aerobic Exercise Training for 4 months
Other: Physical exercise
Experimental: Inspiratory Muscle Training
Isolate Inspiratory Muscle Training for 4 months
Other: Physical exercise
Experimental: Aerobic Exercise Training + Inspiratory Muscle Training
Aerobic Exercise Training associated with Inspiratory Muscle Training for 4 months
Other: Physical exercise

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 6, 2012
Last Updated: December 11, 2012
Health Authority: Brazil: Ethics Committee

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

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 22, 2014