Heart Failure Clinical Trial
— CPAPOfficial 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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | October 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Age range 20-70 years - New York Heart Association Class II-III - Clinically stable for one month - Ejection fraction <40% - Peak VO2 <20 ml/kg/min - Stable and optimized medical therapy at least one month before the study - B-blocker therapy - Clinical and polysomnographic diagnosis of sleep apnea (IAH>10) Exclusion Criteria: - Patients with previous treatment of sleep apnea - New York Heart Association Class IV - Clinical instability - Poor adherence to drug treatment - Myocardial infarction or revascularization within the past two months - Unstable angina - Symptomatic arrhythmias (pacemaker and defibrillator) - Obstructive aortic or mitral valvular disease - Hypertrophic cardiomyopathy - Abnormal exercise testing - Pulmonary arterial pressure >50mmHg - Chronic obstructive pulmonary disease - Intermittent leg claudication - Musculoskeletal disorders or psychiatric disease that prevents the patient from understanding and following the exercise prescription safely |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Universidade Federal de Sao Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Associação Fundo de Incentivo à Pesquisa |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Polysomnography | To evaluate changes from Baseline in quality of sleep, mainly sleep apnea, after 3 months. Overnight polysomnography will be perform using a digital system with 17 channels(EMBLA, Medicare Medical Devices). The following variables will be monitor: electroencephalogram, electrooculogram, electromyogram, electrocardiogram,snoring and body position. Airflow will be monitor using a thermocouple and pressure transducer. Chest and abdominal piezo-sensors will monitor respiratory effort. Arterial oxygen saturation and pulse will be record with a pulse oxymeter. | Two evaluations (baseline and 3 month) | Yes |
Secondary | Cardiopulmonary exercise testing | To evaluate changes from Baseline in functional capacity, after 3 months. All patients will realize a symptom limited, treadmill test with respiratory gas exchange analysis, according to Weber protocol. Heart rate and rhythm were monitored by 12-lead electrocardiogram. Blood pressure was determined by a mercury sphygmomanometer at rest and at the end of each stage. The self-perceived level of exertion (15-point Borg scale) was assessed at peak effort. | Two evaluations (baseline and 3 month) | Yes |
Secondary | Isokinetic strength and endurance | To evaluate changes from Baseline in strenght and endurance of legs after 3 months. Strength and endurance of the knee extensors and flexors were measured using an isokinetic dynamometer, which modifies the speed and angle of movements. The test protocol consisted of a warm-up (five minutes on a cycle ergometer), three repetitions at 60degree/second (Maximal dynamic strength, peak torque - Nm) and 10 repetitions at 180degree/second (endurance, total work - J), followed by a cool-down (five minutes on a cycle ergometer). | Two evaluations (baseline and 3 month) | Yes |
Secondary | Quality of Life | To evaluate changes from Baseline in quality of life after 3 months. Quality of life will be measure by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) that assesses disease-specific health-related quality of life by including the patient's perception of the effects of chronic heart failure and its treatment on daily life. And by 36-item Short-Form Health Survey (SF-36) that is a generic instrument to evaluate the quality of life. | Two evaluations (baseline and 3 month) | Yes |
Secondary | Sexual Function | To evaluate changes from Baseline in sexual function after 3 months. Sexual function of men will be evaluate by the questionnaire Quociente Sexual Masculino (QS-M) and sexual function of women will be evaluate by the questionnaire Quociente Sexual Feminino (QS-F). Both questionnaires evaluate the sexual function of men and women in a comprehensive way to measure the elements of physical, emotional and relational. | Two evaluations (baseline and 3 month) | Yes |
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