Clinical trial NCT01538069: Heart Failure and Sleep Apnea: Exercise Training and Continuous Positive Airway Pressure
Official title: Comparison Between Exercise Training and CPAP Treatment for Patients With Heart Failure and Sleep Apnea.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Sleep Apnea Syndromes
Keywords: Heart failure
Sleep apnea syndromes
Exercise
Continuous Positive Airway Pressure
Lead sponsor: Associação Fundo de Incentivo à Pesquisa
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Polysomnography
timeFrame: Two evaluations (baseline and 3 month)
Secondary outcomes:
measure: Cardiopulmonary exercise testing
timeFrame: Two evaluations (baseline and 3 month)
measure: Isokinetic strength and endurance
timeFrame: Two evaluations (baseline and 3 month)
measure: Quality of Life
timeFrame: Two evaluations (baseline and 3 month)
measure: Sexual Function
timeFrame: Two evaluations (baseline and 3 month)
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Denise M Servantes, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bittencourt L, Javaheri S, Servantes DM, Kravchychyn ACP, Almeida DR, Tufik S. In patients with heart failure, enhanced ventilatory response to exercise is associated with severe obstructive sleep apnea. J Clin Sleep Med. 2021 Sep 1;17(9):1875-1880. doi: 10.5664/jcsm.9396.