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

NCT ID: NCT02758600

Last Updated: 2016-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Cycle ergometer exercise rehabilitation protocol

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Cycle ergometer exercise rehabilitation protocol

Intervention Type OTHER

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

Interventions

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Cycle ergometer exercise rehabilitation protocol

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Isadora Salvador Rocco

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitary Hospital of Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Isadora S Rocco, Miss

Role: CONTACT

+55 11 958506717

Solange Guizilini, Dr

Role: CONTACT

+55 11 982887753

Facility Contacts

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Isadora s Rocco, Miss

Role: primary

+55 11 958506717

Other Identifiers

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53016216.3.0000.5505

Identifier Type: -

Identifier Source: org_study_id

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