Cardiopulmonary and Metabolic Responses to Early Exercise in Patients After Coronary Arterial Bypass Grafting

Cardiopulmonary and Metabolic Responses in Early Exercise-based Rehabilitation in Patients With or Without Left Ventricular Dysfunction After Coronary Arterial Bypass Grafting

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 Overview

• Status: Unknown
• Conditions: Physical Activity; Coronary Artery Bypass Graft Triple Vessel; Acute Myocardial Infarction: Rehabilitation Phase
• Intervention / Treatment: Other: Cycle ergometer exercise rehabilitation protocol

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isadora S Rocco, Miss; Phone Number: +55 11 958506717; Email: isarocco@gmail.com
• Study Contact Backup: Name: Solange Guizilini, Dr; Phone Number: +55 11 982887753; Email: s_guizilini@yahoo.com.br

Study Locations

• Brazil
  • Sao Paulo, Brazil, 04020040
    • Recruiting
    • Universitary Hospital of Federal University of Sao Paulo
    • Contact: Isadora s Rocco, Miss; Phone Number: +55 11 958506717

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LVEF < 45%; Patients with left ventricular dysfunction will be evaluated before and 6 days after after coronary arterial bypass graft surgery. Postoperatively, subjects will be submitted to a portable cycle ergometer exercise protocol from the first day until hospital discharge.	Other: Cycle ergometer exercise rehabilitation protocol; Patients will be submitted to a progressive and moderate exercise protocol with a portable cycle ergometer.
Experimental: LVEF > 45%; Patients without left ventricular dysfunction will be evaluated before and 6 days after after coronary arterial bypass graft surgery. Postoperatively, subjects will be submitted to a portable cycle ergometer exercise protocol from the first day until hospital discharge.	Other: Cycle ergometer exercise rehabilitation protocol; Patients will be submitted to a progressive and moderate exercise protocol with a portable cycle ergometer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute walk test to measure functional capacity	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.	6 days
Short-term complications	Incidence of arrythmias, pulmonary complications (pleural effusion, pulmonary atelectasis and pneumonia)	Until hospital discharge, an average of 15 days
Shuttle walk test to measure functional capacity	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.	6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary Dysfunction	By spirometry, assessing the decrease in forced vital capacity and changes in exhaled volume forced in first second postoperativetly compare to preoperative period.	6 days (on the 1th, 3th and 6th day after surgery)
Respiratory weakness	By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure postoperativetly compare to preoperative period.	6 days (on the 1th, 3th and 6th day after surgery)
Oxygen Consumption	Evaluate the oxygen consumption in metabolic equivalents (METS) during the cycle ergometer in post operative period by using spirometic-telemetric portable device during sessions.	First 6 days after surgery
Mid and Long Term Complications	Complications such as angina recurrence, hospital readmission, cardiac events and all cause mortality.	3 months to 1 year

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: April 23, 2016
• First Submitted That Met QC Criteria: April 29, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Estimate): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 15, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: 53016216.3.0000.5505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO