NCT01538069

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

Comparison Between Exercise Training and CPAP Treatment for Patients With Heart Failure and Sleep Apnea.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Associação Fundo de Incentivo à Pesquisa · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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).
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.
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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-08-01
• Completion: 2013-10-01
• First posted: 2012-02-23
• Last updated: 2013-08-09

Locations

1 site across 1 country: Brazil