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
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Other: Inspiratory muscle added by aerobic to aerobic alone||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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 ]
- 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 ]
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
|Contact: Jorge P. Ribeiro, MD, ScD||+55 51 9982 email@example.com|
|Contact: Eliane R. Winkelmann, MS||+55 55 9922 firstname.lastname@example.org|
|Hospital de Clínicas de Porto Alegre||Recruiting|
|Porto Alegre, RS, Brazil, 90035-003|
|Contact: Jorge P. Ribeiro, MD, ScD +55 51 9982 4984 email@example.com|
|Contact: Eliane Winkelmann, MS +55 55 9922 4402 firstname.lastname@example.org|
|Principal Investigator: Jorge P. Ribeiro, MD, ScD|
|Principal Investigator:||Jorge P. Ribeiro, MD, ScD||Associate Professor and Chief of Non-invasive Cardiology|