Impact of Mobilization on Cardiac Surgery

NCT02312648 | Completed

• 1 other identifier: UNICID
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative; Dysfunction Following Cardiac Surgery

Keywords

Functional Capacity; Physical Exertion; Patient Care; Early mobilization

Outcome Measures

Primary Outcomes (1)

• Functional Capacity

  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 Outcomes (2)

• Intensive Care Unit (ICU) and Hospital length of stay

  All patients will be followed for the duration of hospital stay, an expected average of 30 days

• Postoperative pulmonary complication (PPC)

  All patients will be followed for the duration of hospital stay, an expected average of 30 days

Study Arms (2)

Early mobilization Group

ACTIVE COMPARATOR

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

Control Group - Respiratory exercise

OTHER

Respiratory exercises with patient sitting in bed with a high headboard 45, the same breathing exercises will be held

Other: Control group

Interventions

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.

Early mobilization Group

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.

Control Group - Respiratory exercise

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• : 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.

Sponsors & Collaborators

• Luciana Chiavegato: lead

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Luciana D Chiavegato, PhD

  Universidade Cidade de São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Master's and Doctoral Programs in Physical Therapy of Universidade Cidade de São Paulo

Study Record Dates

• First Submitted: November 8, 2014
• First Posted: December 9, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2016
• Last Updated: June 7, 2018

Record last verified: 2018-06