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

NCT02758600 | Unknown

• 1 other identifier: 53016216.3.0000.5505
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (2)

LVEF < 45%

EXPERIMENTAL

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

LVEF > 45%

EXPERIMENTAL

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

Interventions

Cycle ergometer exercise rehabilitation protocol OTHER

Patients will be submitted to a progressive and moderate exercise protocol with a portable cycle ergometer.

LVEF < 45%; LVEF > 45%

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Universitary Hospital of Federal University of Sao Paulo

São Paulo, São Paulo, 04020040, Brazil

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Isadora S Rocco, Miss

CONTACT

+55 11 958506717; isarocco@gmail.com

Solange Guizilini, Dr

CONTACT

+55 11 982887753; s_guizilini@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2016
• First Posted: May 2, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2017
• Last Updated: August 17, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)