Impact of an Early Mobilization Program on Functional Capacity After Coronary Artery Bypass Surgery: a Protocol of Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Primary Endpoint
- Functional Capacity
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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).
Intervention: Interventional Group (Other)
Control Group - Respiratory exercise
Respiratory exercises with patient sitting in bed with a high headboard 45, the same breathing exercises will be held
Intervention: Control group (Other)
Outcomes
Primary Outcomes
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
- 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)
Investigators
Luciana Chiavegato
Professor of Master's and Doctoral Programs in Physical Therapy of Universidade Cidade de São Paulo
Universidade Cidade de Sao Paulo