The Effects of the Inspiratory Muscle Plus Aerobic Training Compare to Aerobic Training Alone in Heart Failure Patients.
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Mar 2005
Longer than P75 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 6, 2008
CompletedFirst Posted
Study publicly available on registry
March 13, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedMarch 13, 2008
March 1, 2008
3 years
March 6, 2008
March 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare effects of inspiratory muscle training added by aerobic training to aerobic training alone in heart failure patients with inspiratory muscle weakness.
one year
Secondary Outcomes (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.
one year
Study Arms (1)
G2
ACTIVE COMPARATORInspiratory muscle training added by aerobic training to aerobic training alone
Interventions
Inspiratory muscle added by aerobic to aerobic alone
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Related Publications (1)
Winkelmann ER, Chiappa GR, Lima CO, Viecili PR, Stein R, Ribeiro JP. Addition of inspiratory muscle training to aerobic training improves cardiorespiratory responses to exercise in patients with heart failure and inspiratory muscle weakness. Am Heart J. 2009 Nov;158(5):768.e1-7. doi: 10.1016/j.ahj.2009.09.005. Epub 2009 Oct 2.
PMID: 19853695DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jorge P. Ribeiro, MD, ScD
Associate Professor and Chief of Non-invasive Cardiology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 6, 2008
First Posted
March 13, 2008
Study Start
March 1, 2005
Primary Completion
March 1, 2008
Study Completion
March 1, 2010
Last Updated
March 13, 2008
Record last verified: 2008-03