Impact of Mobilization on Cardiac Surgery

June 5, 2018 updated by: Luciana Chiavegato

Impact of an Early Mobilization Program on Functional Capacity After Coronary Artery Bypass Surgery: a Protocol of Randomized Controlled Trial.

The objective of this study is to investigate the effects of a program of early mobilization in the functional capacity in patients undergoing coronary artery bypass grafting in short and long- term.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The hypotheses this study is that patients if conduct the program of early mobilization during hospitalization achieve better performance in the walk test (distance) at hospital discharge and 60 days after the surgical procedure compared to patients who only carry out the program of respiratory exercises. Intervention and control groups will receive breathing exercises up to 24 hours postoperatively, and the intervention group will also receive early mobilization exercises.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consecutive patients admitted to elective and conventional coronary artery bypass, Body Mass Index (BMI) between 20 and 30 Kg/m2, mechanical ventilation time under than 24 hours, hemodynamic stability with or without use of positive inotropes, absence of arrhythmias and angina, mean arterial pressure (MAP) 60<PAM<100 mmHg, heart frequency (HR) 60<FC<100 bpm without signs of respiratory distress such as flaring nose, use of accessory muscles, thoracoabdominal asynchrony, respiratory frequency (f) ≤ 20 bpm without signs of infection were included in this study.

Exclusion Criteria:

  • : presence of previous pulmonary disease, ejection fraction under 35% or longer than 54%, reoperation, intraoperative death or any contraindications to perform the proposed measurements and/or treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Early mobilization Group
Patients will perform deep breaths (3 sets of 10 repetitions), once a day, for 30 minutes until 7th postoperative day. Non invasive ventilation will be installed after orotracheal extubation for 30 to 60 minutes.Early mobilization protocol consist of upper and lower (cycle ergometer) limb exercises, chair transfer, deambulation for 10 to 20 minutes, step exercise (six times).
Other: Interventional Group
Respiratory exercises will be performed and subsequently active upper limb exercises will be conducted (flexion-extension and adduction-abduction) of large joints (shoulder, elbow and wrist) Associated with upper limb exercises, patients will undergo a series of exercises ergometer with lower limb (LL). The mobilization will be conducted on a cycle ergometer in an active, lasting 20 minutes, divided into three steps: heat 5 minutes; 10 minutes of low intensity exercise, with a speed of 30 revolutions per minute (rpm); and 5 minutes recovery. The patient remains in the supine position with the head of the bed elevated to 45 degrees, while the lower limbs will remain planned. After positioning the patient, the ergometer is adjusted.
Other: Control Group - Respiratory exercise
Respiratory exercises with patient sitting in bed with a high headboard 45, the same breathing exercises will be held
Other: Control group
The patients will oriented to maintain sitting position and perform deep breaths (3 sets of 10 repetitions) in each session. They will receive the intervention once a day, for 30 minutes until 7th postoperative day. In addition, non invasive ventilation will be installed after orotracheal extubation for 30 to 60 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional Capacity
Time Frame: All patients will be evaluated on preoperative period ( when they arrived in the hospital to do the surgery), hospital discharge ( about a mean of two weeks afeter surgery) and 60 postoperative days in cargiology ambulatory
Patients will be submitted to six minute walking test
All patients will be evaluated on preoperative period ( when they arrived in the hospital to do the surgery), hospital discharge ( about a mean of two weeks afeter surgery) and 60 postoperative days in cargiology ambulatory

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intensive Care Unit (ICU) and Hospital length of stay
Time Frame: All patients will be followed for the duration of hospital stay, an expected average of 30 days
The number the days in ICU and hospital until discharge will be counted for each patient
All patients will be followed for the duration of hospital stay, an expected average of 30 days
Postoperative pulmonary complication (PPC)
Time Frame: All patients will be followed for the duration of hospital stay, an expected average of 30 days
The occurrence of PPC will be monitored until the day of hospital discharge by a physician blinded to the groups: pneumonia (chest radiography with pulmonary infiltrate associated with two of the following signs: purulent expectoration, temperature above 38.3º C and a greater than 25% increase in baseline leukocyte count with hyperthermia), atelectasis (RS associated with abnormal chest acute respiratory symptoms), hypoxemia (peripheral oxygen saturation associated with respiratory symptoms below 85%).
All patients will be followed for the duration of hospital stay, an expected average of 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Luciana Chiavegato

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Luciana D Chiavegato, PhD, Universidade Cidade de Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UNICID

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