Clinical trial NCT02758600: Cardiopulmonary and Metabolic Responses to Early Exercise in Patients After Coronary Arterial Bypass Grafting
Official title: Cardiopulmonary and Metabolic Responses in Early Exercise-based Rehabilitation in Patients With or Without Left Ventricular Dysfunction After Coronary Arterial Bypass Grafting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction: Rehabilitation Phase
Coronary Artery Bypass Graft Triple Vessel
Physical Activity
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Coronary arterial bypass graft surgery (CABG) is proven safe with improved survival and greater quality of life in patients with coronary arterial disease. Evidences on the cardiovascular and gas-exchanges responses during and right after early exercise-based rehabilitation of this patients are limited. Objective: The investigators aim to analyse breath-by-breath cardiopulmonary and metabolic responses during six-minute walk test (6MWT) and shuttle walk test (SWT) in patients with or without left ventricular dysfunction (LVD) after CABG. In addition, the investigators will investigate oxygen consumption and cardiopulmonary responses during the early exercise-based rehabilitation in the first days after surgery. Methods: According to the left ventricular ejection fraction (LVEF), subjects will be allocated into two groups: with LVD (LVEF \< 45%) and without LVD (LVEF \> 45%). Patients will be submitted to the 6MWT and SWT linked to portable spirometric-telemetric device before and 6 days after CABG. During the first days after surgery, patients will be evaluated about pulmonary function and respiratory strenght at rest and oxygen consumption during the portable cycle ergometer protocol. Clinical outcomes as time to hospital discharge, pulmonary complications and occurence of arrythmias will be assessed during inpatient time until hospital discharge. Incidence of mortality, hospital readmission and angina recurrence will be evaluated in a one-year follow up.


Eligibility criteria: Inclusion Criteria:

* Age between 35 to 75 years old;
* Coronary arterial disease proved by coronary angiography
* Elective Coronary arterial bypass grafting

Exclusion Criteria:

* Pulmonary chronic disease
* Disabling neurological or orthopedic disease
* Morbidity obesity
* Urgency surgery
* Bilateral pleural opening
* Arrhythmias during exercise protocol
* Prolonged mechanical ventilation (\>12 hours)
* Inability to comprehend or perform the tests

Primary outcomes:
measure: Six-minute walk test to measure functional capacity
timeFrame: 6 days
measure: Short-term complications
timeFrame: Until hospital discharge, an average of 15 days
measure: Shuttle walk test to measure functional capacity
timeFrame: 6 days
Secondary outcomes:
measure: Pulmonary Dysfunction
timeFrame: 6 days (on the 1th, 3th and 6th day after surgery)
measure: Respiratory weakness
timeFrame: 6 days (on the 1th, 3th and 6th day after surgery)
measure: Oxygen Consumption
timeFrame: First 6 days after surgery
measure: Mid and Long Term Complications
timeFrame: 3 months to 1 year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universitary Hospital of Federal University of Sao Paulo
Study officials:
References: