search
Back to results

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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cycle ergometer exercise rehabilitation protocol
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction: Rehabilitation Phase

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitary Hospital of Federal University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

LVEF < 45%

LVEF > 45%

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Short-term complications
Incidence of arrythmias, pulmonary complications (pleural effusion, pulmonary atelectasis and pneumonia)
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.

Secondary Outcome Measures

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.
Respiratory weakness
By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure postoperativetly compare to preoperative period.
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.
Mid and Long Term Complications
Complications such as angina recurrence, hospital readmission, cardiac events and all cause mortality.

Full Information

First Posted
April 23, 2016
Last Updated
August 15, 2016
Sponsor
Federal University of São Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT02758600
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction: Rehabilitation Phase, Coronary Artery Bypass Graft Triple Vessel, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LVEF < 45%
Arm Type
Experimental
Arm Description
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.
Arm Title
LVEF > 45%
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cycle ergometer exercise rehabilitation protocol
Intervention Description
Patients will be submitted to a progressive and moderate exercise protocol with a portable cycle ergometer.
Primary Outcome Measure Information:
Title
Six-minute walk test to measure functional capacity
Description
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.
Time Frame
6 days
Title
Short-term complications
Description
Incidence of arrythmias, pulmonary complications (pleural effusion, pulmonary atelectasis and pneumonia)
Time Frame
Until hospital discharge, an average of 15 days
Title
Shuttle walk test to measure functional capacity
Description
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.
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Pulmonary Dysfunction
Description
By spirometry, assessing the decrease in forced vital capacity and changes in exhaled volume forced in first second postoperativetly compare to preoperative period.
Time Frame
6 days (on the 1th, 3th and 6th day after surgery)
Title
Respiratory weakness
Description
By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure postoperativetly compare to preoperative period.
Time Frame
6 days (on the 1th, 3th and 6th day after surgery)
Title
Oxygen Consumption
Description
Evaluate the oxygen consumption in metabolic equivalents (METS) during the cycle ergometer in post operative period by using spirometic-telemetric portable device during sessions.
Time Frame
First 6 days after surgery
Title
Mid and Long Term Complications
Description
Complications such as angina recurrence, hospital readmission, cardiac events and all cause mortality.
Time Frame
3 months to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isadora S Rocco, Miss
Phone
+55 11 958506717
Email
isarocco@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Solange Guizilini, Dr
Phone
+55 11 982887753
Email
s_guizilini@yahoo.com.br
Facility Information:
Facility Name
Universitary Hospital of Federal University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04020040
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isadora s Rocco, Miss
Phone
+55 11 958506717

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs