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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02758600
• Other study ID #: 53016216.3.0000.5505
• Status: Recruiting
• Phase: N/A
• First received: April 23, 2016
• Last updated: August 15, 2016
• Start date: March 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Federal University of São Paulo
• Contact: Isadora S Rocco, Miss
• Phone: +55 11 958506717
• Email: isarocco[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction: Rehabilitation Phase
• Coronary Artery Bypass Graft Triple Vessel
• Infarction
• Myocardial Infarction
• Physical Activity

Intervention

Other:
• Cycle ergometer exercise rehabilitation protocol
Patients will be submitted to a progressive and moderate exercise protocol with a portable cycle ergometer.

Locations

Country	Name	City	State
Brazil	Universitary Hospital of Federal University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Short-term complications	Incidence of arrythmias, pulmonary complications (pleural effusion, pulmonary atelectasis and pneumonia)	Until hospital discharge, an average of 15 days	No
Primary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No
Secondary	Mid and Long Term Complications	Complications such as angina recurrence, hospital readmission, cardiac events and all cause mortality.	3 months to 1 year	No