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The Effects of the Inspiratory Muscle Plus Aerobic Training Compare to Aerobic Training Alone in Heart Failure Patients.

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ClinicalTrials.gov Identifier: NCT00634296
Recruitment Status : Unknown
Verified March 2008 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : March 13, 2008
Last Update Posted : March 13, 2008
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre

Brief Summary:
This study aims to compare effects of inspiratory muscle training added by aerobic training to aerobic training alone in heart failure patients with inspiratory muscle weakness. To do so, strength and endurance of inspiratory muscles, functional capacity, quality of life, heart rate variability and sleep apnea evaluations will be conducted in patients with heart failure.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Inspiratory muscle added by aerobic to aerobic alone Not Applicable

Detailed Description:

A sample comprising at least 30 individuals is necessary. These subjects will be randomized in two groups, one consisting of inspiratory muscle training plus aerobic training, whereas the other will consist of the aerobic training alone.

This prospective, randomized, controlled trial will include patients with the diagnosis of chronic heart failure attributable to left ventricular systolic dysfunction who will be recruited from the Heart Failure Clinic.

Entry criteria for the study are a previous history of symptomatic heart failure caused by left ventricular systolic dysfunction, inspiratory muscle weakness (PImax < 70% of the predicted), and clinical stability, including no change in medications for the past three months.

Exclusion criteria will be unstable angina, myocardial infarction, or cardiac surgery within the previous three months, chronic metabolic, orthopedic, or infectious diseases, treatments with steroids, hormones, or cancer chemotherapy, history of exercise-induced asthma, chronic obstructive pulmonary disease and smokers will be not recruited.

The protocol was approved by the Committee for Ethics in Research of Hospital de Clinics de Porto Alegre and Ijuí University and all subjects are required to sign an informed consent form.

Variables will be measured by strength and endurance (progressive and constant load), 6-min walk test, cardiopulmonary exercise testing, quality of life questionnaire, evaluation of the heart rate variability and sleep apnea.

The inspiratory muscle training plus aerobic training will consist of cycle exercise (3 sessions/week) and inspiratory exercise by using Threshold equipment for 30 min, 7 times per week, whereas aerobic training group will perform only cycle exercise. Both treatments will last 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of the Inspiratory Muscle Training Plus Aerobic Training Compare to Aerobic Training Alone in Heart Failure Patients With Inspiratory Muscle Weakness.
Study Start Date : March 2005
Estimated Primary Completion Date : March 2008
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: G2
Inspiratory muscle training added by aerobic training to aerobic training alone
Other: Inspiratory muscle added by aerobic to aerobic alone
Inspiratory muscle added by aerobic to aerobic alone
Other Names:
  • Aerobic: G1
  • Inspiratory muscle added by aerobic: G2




Primary Outcome Measures :
  1. To compare effects of inspiratory muscle training added by aerobic training to aerobic training alone in heart failure patients with inspiratory muscle weakness. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. To compare effects between the training groups evaluating strength and endurance of inspiratory muscles; functional capacity; the physical and psychological perceptions of quality of life and heart rate variability and sleep apnea. [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • previous history of symptomatic heart failure caused by left ventricular systolic dysfunction
  • inspiratory muscle weakness (PImax < 70% of the predicted)
  • clinical stability, including no change in medications for the past three months

Exclusion Criteria:

  • unstable angina
  • myocardial infarction, or cardiac surgery within the previous three months
  • chronic metabolic, orthopedic, or infectious diseases
  • treatments with steroids, hormones, or cancer chemotherapy
  • history of exercise-induced asthma, chronic obstructive pulmonary disease
  • smokers

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): NCT00634296


Contacts
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Contact: Jorge P. Ribeiro, MD, ScD +55 51 9982 4984 jpribeiro@cpovo.net
Contact: Eliane R. Winkelmann, MS +55 55 9922 4402 elianew@unijui.edu.br

Locations
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Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-003
Contact: Jorge P. Ribeiro, MD, ScD    +55 51 9982 4984    jpribeiro@cpovo.net   
Contact: Eliane Winkelmann, MS    +55 55 9922 4402    elianew@unijui.edu.br   
Principal Investigator: Jorge P. Ribeiro, MD, ScD         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Jorge P. Ribeiro, MD, ScD Associate Professor and Chief of Non-invasive Cardiology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jorge Pinto Ribeiro, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00634296    
Other Study ID Numbers: HCPA2004-302
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: March 13, 2008
Last Verified: March 2008
Keywords provided by Hospital de Clinicas de Porto Alegre:
Heart failure
Systolic dysfunction
Inspiratory muscle weakness
Additional relevant MeSH terms:
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Muscle Weakness
Respiratory Aspiration
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases