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

NCT ID: NCT01538069

Last Updated: 2013-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise group

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: 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).

CPAP group

Group Type: EXPERIMENTAL

CPAP group

Intervention Type: 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.

Exercise and CPAP group

Group Type: EXPERIMENTAL

Exercise and CPAP group

Intervention Type: OTHER

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

Interventions

Exercise training

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).

Intervention Type: OTHER

CPAP group

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.

Intervention Type: OTHER

Exercise and CPAP group

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Lia Azeredo-Bittencourt

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Denise M Servantes, PT

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Universidade Federal de Sao Paulo

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Lia Rita A Bittencourt, MD

Role: CONTACT

Phone: 55 11 21490155

Email: lia.rita@unifesp.br

Facility Contacts

Lia Rita A Bittencourt, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 33949944 (View on PubMed)

Other Identifiers

CEP1226/11

Identifier Type: -

Identifier Source: org_study_id