Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02758600
Enrollment
30
Registered
2016-05-02
Start date
2016-03-31
Completion date
2017-12-31
Last updated
2016-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERCycle ergometer exercise rehabilitation protocol

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

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Six-minute walk test to measure functional capacity6 daysAccording 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 complicationsUntil hospital discharge, an average of 15 daysIncidence of arrythmias, pulmonary complications (pleural effusion, pulmonary atelectasis and pneumonia)
Shuttle walk test to measure functional capacity6 daysAccording 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

MeasureTime frameDescription
Pulmonary Dysfunction6 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.
Mid and Long Term Complications3 months to 1 yearComplications such as angina recurrence, hospital readmission, cardiac events and all cause mortality.
Respiratory weakness6 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.
Oxygen ConsumptionFirst 6 days after surgeryEvaluate the oxygen consumption in metabolic equivalents (METS) during the cycle ergometer in post operative period by using spirometic-telemetric portable device during sessions.

Countries

Brazil

Contacts

Primary ContactIsadora S Rocco, Miss
isarocco@gmail.com+55 11 958506717
Backup ContactSolange Guizilini, Dr
s_guizilini@yahoo.com.br+55 11 982887753

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026