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Sponsored by: |
Hospital de Clinicas de Porto Alegre |
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Information provided by: | Hospital de Clinicas de Porto Alegre |
ClinicalTrials.gov Identifier: | NCT00634296 |
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 | Intervention |
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Heart Failure |
Other: Inspiratory muscle added by aerobic to aerobic alone |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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. |
Estimated Enrollment: | 30 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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G2: Active Comparator
Inspiratory muscle training added by aerobic training to aerobic training alone
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Other: Inspiratory muscle added by aerobic to aerobic alone
Inspiratory muscle added by aerobic to aerobic alone
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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.
Ages Eligible for Study: | 25 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Brazil, RS | |
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 |
Principal Investigator: | Jorge P. Ribeiro, MD, ScD | Associate Professor and Chief of Non-invasive Cardiology |
Responsible Party: | Hospital de Clínicas de Porto Alegre ( Jorge Pinto Ribeiro ) |
Study ID Numbers: | HCPA2004-302 |
Study First Received: | March 6, 2008 |
Last Updated: | March 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00634296 History of Changes |
Health Authority: | Brazil: Ministry of Health |
Heart failure Systolic dysfunction Inspiratory muscle weakness |
Heart Failure Heart Diseases Asthenia Muscle Weakness |
Heart Failure Heart Diseases Cardiovascular Diseases |