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

Sponsor
Federal University of São Paulo (Other)
Overall Status
Unknown status
CT.gov ID
NCT02758600
Collaborator
(none)
30
1
2
21
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cycle ergometer exercise rehabilitation protocol
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
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 Start Date :
Mar 1, 2016
Anticipated Primary Completion Date :
Nov 1, 2016
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Six-minute walk test to measure functional capacity [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.

  2. Short-term complications [Until hospital discharge, an average of 15 days]

    Incidence of arrythmias, pulmonary complications (pleural effusion, pulmonary atelectasis and pneumonia)

  3. Shuttle walk test to measure functional capacity [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 Outcome Measures

  1. Pulmonary Dysfunction [6 days (on the 1th, 3th and 6th day after surgery)]

    By spirometry, assessing the decrease in forced vital capacity and changes in exhaled volume forced in first second postoperativetly compare to preoperative period.

  2. Respiratory weakness [6 days (on the 1th, 3th and 6th day after surgery)]

    By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure postoperativetly compare to preoperative period.

  3. Oxygen Consumption [First 6 days after surgery]

    Evaluate the oxygen consumption in metabolic equivalents (METS) during the cycle ergometer in post operative period by using spirometic-telemetric portable device during sessions.

  4. Mid and Long Term Complications [3 months to 1 year]

    Complications such as angina recurrence, hospital readmission, cardiac events and all cause mortality.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 75 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitary Hospital of Federal University of Sao Paulo Sao Paulo Brazil 04020040

Sponsors and Collaborators

  • Federal University of São Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Isadora Salvador Rocco, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT02758600
Other Study ID Numbers:
  • 53016216.3.0000.5505
First Posted:
May 2, 2016
Last Update Posted:
Aug 17, 2016
Last Verified:
Aug 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2016