Bilevel Positive Pressure Airway
DeviceHeart rehabilitation with noninvasive ventilation, for 12 weeks, 3 times a week
NCT Number: NCT02811146
The study aims to demonstrate the efficacy of NIV continuously in cardiac rehabilitation programs, improvement of exercise tolerance, with consequent reflection in functional capacity and quality of life of this population.
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Notify Me21 year–65 year
All sexes
Interventional
Not applicable
Cardiopulmonary Physiotherapy Laboratory, Recife, Pernambuco, Brazil
BACKGROUND: Heart failure (HF) is a cardiovascular syndrome with enormous impact on public health by high morbidity and mortality rates that are associated. Studies show that changes in striated skeletal muscle of those individuals, possibly caused by progressive physical inactivity, contribute to the construction of the pathophysiology of this disease, emphasizing the importance of exercise for these patients. Exercise programs can be traced safer and related form the actual functional capacity thereof. Cardiac rehabilitation it is a set of activities that aims to ensure that patients with heart disease the best conditions, especially physical. In this context, non-invasive ventilation (NIV) is an alternative to provide an improved tolerance during exercise in patients with HF.
GOALS: Evaluate the effectiveness of the use of NIV association to aerobic exercise in exercise programs supervised during cardiac rehabilitation exercise tolerance and quality of life in patients with heart failure when compared to performing these exercises without ventilatory support.
METHODS: This is a clinical trial, controlled, randomized and blind to be developed with patients arising out of the main Recife reference centers in the care of patients with heart failure. It will be conducted assessments of functional capacity made by cardiopulmonary exercise testing (CPET), the Glittre-ADL test and through the questionnaire Duke Activity Status Index (DASI), assessment of quality of life using the questionnaire Minnesota Living with Heart Failure (MLWHF), and finally, in order to determine a clinical change, will be used to Patient Global Impression of Change Scale (PGIS).
EXPECTED RESULTS: This study aims to demonstrate the efficacy of NIV continuously in cardiac rehabilitation programs, improvement of exercise tolerance, with consequent reflection in functional capacity and quality of life of this population.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Heart rehabilitation with noninvasive ventilation, for 12 weeks, 3 times a week
Heart rehabilitation, for 12 weeks, 3 times a week
Time frame: Baseline and 12 weeks
Change in functional capacity
Time frame: Baseline and 12 weeks
Change in submaximal functional capacity
Time frame: Baseline
Change in submaximal functional capacity
Time frame: Baseline and 12 weeks
Compare the ventilatory metabolic response of the six-minute walk test and Glittre-ADL Test
Time frame: Baseline and 12 weeks
Improved in quality of life
Time frame: Baseline and 12 weeks
Change in the body composition
Universidade Federal de Pernambuco
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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