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Completed

NCT Number: NCT02312648

Impact of Mobilization on Cardiac Surgery

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.

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Key information

Conditions

Postoperative; Dysfunction Following Cardiac Surgery

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interventional group

Other

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.

Control Group

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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%).

Sponsors and collaborators

Lead sponsor

Luciana Chiavegato

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 9, 2014
Registry last updated
Jun 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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