Heart Failure Clinical Trial
Official title:
Comparison Between Exercise Training and CPAP Treatment for Patients With Heart Failure and Sleep Apnea.
Introduction. Heart failure is the result of primary ventricular dysfunction followed by
neurohormorais changes, distribution of cardiac output, peripheral circulation, the skeletal
and respiratory muscles, which determine their clinical and prognosis. Despite the
advancement in treatment, morbidity and mortality remain high. Physical training appears as
a therapeutic strategy, because most of its beneficial effects is by inducing changes in
peripheral physiological changes resulting from heart failure. Associated factors that may
contribute to its progression and worse prognosis, now beginning to be studied, such as
sleep apnea, the diagnosis provides important prognostic information and a potential
therapeutic option for these patients.
Objectives. Demonstrate the benefits of physical training for patients with heart failure
and sleep apnea, and compare treatment with CPAP alone and associated with the exercise
program. Will also be assessed risk and adherence to physical training.
Material and Methods. The design will be prospective, longitudinal, randomized consecutive
patients. After screening and baseline evaluations the patients will be randomized into
Group 1 (CPAP, n = 20), Group 2 (CPAP + Physical training, n = 20), Group 3 (Physical
Training, n = 20) and Group 4 (Control without intervention, n = 20). Outcomes (baseline and
3 months): Quality of sleep (polysomnography), Quality of life (Minnesota and SF-36), sexual
function (QS-M and QS-F) and functional capacity (cardiopulmonary exercise testing and
isokinetic testing). Physical training: aerobic and resistance exercises three times a week
for three months. CPAP therapy:after polysomnography for titration with ventilator
servo-assisted, and outpatient follow monthly, for three months.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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