Clinical trial NCT02763774: Effects a Rehabilitation Program in Patients With Left Ventricular Dysfunction After Coronary Artery Bypass Grafting
Official title: Effects of Exercise Rehabilitation Program at Hospitalar Fase on Inflammatory Markers, Functional Capacity and Clinical Outcomes in Patients With Left Ventricular Dysfunction After Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Disorder; Heart, Functional, Postoperative, Cardiac Surgery
Keywords: coronary artery bypass
sistemic inflammatory response syndrome
left ventricular dysfunction
postoperative complications
physical fitness
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 45
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to analyze effects of three types of cardiac rehabilitation protocol on fuctional capacity, inflammatory markers, pulmonary function and clinical outcomes after coronary artery bypass grafting (CABG) in patients with left ventricular disfunction. Patients will be randomized and allocated in three groups according to type of exercise protocol: 1. walk; 2. cycle; 3. functional electrical stimulation.

Detailed description: Several studies have been demonstrated beneficial effects of exercise to minimize impact of CABG. However, there is no consensus on what kind of exercise is safe and effective for patients with left ventricular dysfunction.

Walking

Eligibility criteria: Inclusion Criteria:

* Coronary artery disease proven by coronary angiography;
* Elective CABG;
* No acute or chronic pulmonary disease;
* Patients after surgery, keep in spontaneous ventilation on first postoperative day;
* Absence of neurological, neuromuscular, musculoskeletal and osteoarticular incapacitating;
* Consent form signed for participation in the survey.

Exclusion Criteria:

* Inability to perform spirometry;
* Presence of acute lung disease or chronic;
* Surgical indication of urgency;
* Morbid obesity;
* Hemodynamics instability at the time of spirometry or during six minutes walking test;
* Intraoperative death or until the sixth postoperative day;
* Patients remaining in mechanical prolonged ventilation for more than 12 hours;
* Severe cardiac arrhythmia during application of assessment protocols and exercises (ventricular tachycardia, atrioventricular block second or degree) any other condition the investigator's discretion put the patient at increased risk with beginning of the year; Any change that may lead to failure of proposed protocols.

Primary outcomes:
measure: Functional Capacity
timeFrame: Up to ten days after surgery, at hospital discharge.
Secondary outcomes:
measure: Inflammatory markers
timeFrame: in-hospital postoperative period, up to ten days after surgery.
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Solange Guizilini, PhD
role: PRINCIPAL_INVESTIGATOR
References: