Clinical trial NCT02794935: The Effects of Inspiratory Muscle Training in Patients With Heart Failure and Obstructive Sleep Apnea Syndrome
Official title: The Effects of Inspiratory Muscle Training in Patients With Heart Failure and Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Heart Failure
Keywords: inspiratory muscle training
heart failure
obstructive sleep apnea
Lead sponsor: University of Cruz Alta
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2016-06-09
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research aims to evaluate the effects of inspiratory muscle training (IMT) on apnea hypopnea index, sleepiness, sleep quality, cognitive function, motor task, executive function, quality of life, chemoreflex sensitivity and vagal modulation of heart rate in patients with heart failure and obstructive sleep apnea syndrome.

Detailed description: Patients with heart failure will be selected through the Outpatient of the Rio Grande do Sul, for convenience. Subsequently, patients will be subjected to test respiratory muscle strength (manometer), respiratory muscle endurance, portable polysomnography, sleepiness, sleep quality, cognitive function (mini-mental state examination), motor task (execution of a sequence of digital movements), executive function, quality of life (SF-36), maximum exercise testing, chemoreflex sensitivity (peripheral chemoreflex by transient hypoxia and central chemoreflex by hypercapnic hyperoxia) and vagal modulation of heart rate (spectral analysis) before the start of the training protocol. Patients will be randomized to inspiratory muscle training or control group. Inspiratory muscle training will be performed for 30 minutes a day, 7 days a week, for 12 weeks with muscle training device (PowerBreathe). There will be a weekly monitoring in the Clinical Research Center of the institution where the maximal inspiratory pressure (MIP) and respiratory training techniques will be reassessed and readjusted (30% of MIP). The control group will be submitted to respiratory training techniques with muscle training device (PowerBreathe) without load. After this period, all initial tests will be reassessed. A group study with 15 heart failure patients without obstructive sleep apnea syndrome will be included.

Eligibility criteria: Inclusion Criteria:

* Heart failure patients with obstructive sleep apnea- hypopnea
* Heart failure patients without sleep apnea
* Left ventricle fraction ejection \< 51 % for men and \< 53% for woman
* Must be clinically stable
* New York Heart Association I, II and III
* Without changes in medication for the last three months.

Exclusion Criteria:

* Unstable angina
* Atrial fibrillation
* Acute myocardial infarction (\<6 months)
* Recent heart surgery (\<6 months)
* Chronic metabolic disease
* Infectious disease
* Anemia
* Severe hypoxemia
* Neuromuscular disease
* Diabetes mellitus
* Obesity
* Use of continuous positive airway pressure
* Smoking
* Pulmonary disease (forced vital capacity \<80% of predicted and / or forced expiratory volume in one second \<70% predicted).

Primary outcomes:
measure: Apnea hypopnea index
timeFrame: 12 weeks
Secondary outcomes:
measure: sleepiness
timeFrame: 12 weeks
measure: sleep quality
timeFrame: 12 weeks
measure: cognitive function
timeFrame: 12 weeks
measure: motor task
timeFrame: 12 weeks
measure: executive function measured by Trail Making Test
timeFrame: 12 weeks
measure: quality of life assessed by the The Medical Outcomes Study - Short-form 36 (SF-36)
timeFrame: 12 weeks
measure: peak oxygen consumption
timeFrame: 12 weeks
measure: chemoreflex sensitivity
timeFrame: 12 weeks
measure: vagal modulation measured by heart rate monitoring in the time domain (spectral analysis)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cruz Alta
country: Brazil
facility: University of Cruz Alta
state: Rio Grande do Sul
Study officials:
affiliation: University of Cruz Alta
name: Carine C Callegaro, PhD
role: PRINCIPAL_INVESTIGATOR
References: