Heart Failure and Sleep Apnea: Exercise Training and Continuous Positive Airway Pressure

NCT01538069 | Unknown DMC

• 1 other identifier: CEP1226/11
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Sleep Apnea Syndromes

Keywords

Heart failure; Sleep apnea syndromes; Exercise; Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Cardiopulmonary exercise testing

  Two evaluations (baseline and 3 month)

• Isokinetic strength and endurance

  Two evaluations (baseline and 3 month)

• Quality of Life

  Two evaluations (baseline and 3 month)

• Sexual Function

  Two evaluations (baseline and 3 month)

Study Arms (4)

Control group

NO INTERVENTION

Exercise group

EXPERIMENTAL

Other: Exercise training

CPAP group

EXPERIMENTAL

Other: CPAP group

Exercise and CPAP group

EXPERIMENTAL

Other: Exercise and CPAP group

Interventions

Exercise training OTHER

It consisted of three sessions/week, on non-consecutive days. The aerobic protocol consisted of a warm-up (strengthening exercises, 10 minutes), aerobic exercise (30 minutes in the first month and 45 minutes in the last two months) and cool-down (strengthening exercises, 10 minutes). The aerobic exercise intensity was established by heart rate levels that corresponded to anaerobic threshold, 10 heart rates down and 10 heart rates up, assessed by cardiopulmonary exercise testing. The strength training consisted of eight exercises attending the major muscle groups and the intensity was determined by 50-60% of one-repetition maximum (1-RM) and the progression of the training will be monthly: first month (a series of 12 repetitions with 50% 1-RM), second month (1 set of 15 repetitions with 60% 1-RM) and third months (2 sets of 10 repetitions with 60% 1-RM).

Exercise group

CPAP group OTHER

The CPAP treatment will be according to protocol of the Department of Psychobiology. Titration will be perform after randomization with ventilation device servo-assisted so as to ensure positive pressure within the first 24 hours of treatment. The treatment will be for three months.

CPAP group

Exercise and CPAP group OTHER

The patients randomized for this group will perform both Exercise protocol and CPAP treatment at the same time for three months.

Exercise and CPAP group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Associação Fundo de Incentivo à Pesquisa: lead

Study Sites (1)

Universidade Federal de Sao Paulo

São Paulo, São Paulo, 04023-062, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 33949944 DERIVED

MeSH Terms

Conditions

Heart Failure; Sleep Apnea Syndromes; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Denise M Servantes, PT

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lia Rita A Bittencourt, MD

CONTACT

55 11 21490155; lia.rita@unifesp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: February 23, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: October 1, 2013
• Last Updated: August 9, 2013

Record last verified: 2013-08

Locations

BR (1)