Cardiopulmonary and Metabolic Responses in Early Exercise-based Rehabilitation in Patients With or Without Left Ventricular Dysfunction After Coronary Arterial Bypass Grafting
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Six-minute walk test to measure functional capacity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 35 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Six-minute walk test to measure functional capacity
Time Frame: 6 days
According to the preoperative six-minute walk test linked to portable ergoespirometry device, we will evaluate the decrease in functional capacity in the sixth day after surgery.
Short-term complications
Time Frame: Until hospital discharge, an average of 15 days
Incidence of arrythmias, pulmonary complications (pleural effusion, pulmonary atelectasis and pneumonia)
Shuttle walk test to measure functional capacity
Time Frame: 6 days
According to the preoperative shuttle walk test linked to portable ergoespirometry device, we will evaluate the decrease in functional capacity in the sixth day after surgery.
Secondary Outcomes
- Pulmonary Dysfunction(6 days (on the 1th, 3th and 6th day after surgery))
- Respiratory weakness(6 days (on the 1th, 3th and 6th day after surgery))
- Oxygen Consumption(First 6 days after surgery)
- Mid and Long Term Complications(3 months to 1 year)
Investigators
Isadora Salvador Rocco
Principal Investigator
Federal University of São Paulo