Effects a Rehabilitation Program in Patients With Left Ventricular Dysfunction After Coronary Artery Bypass Grafting

Effects of Exercise Rehabilitation Program at Hospitalar Fase on Inflammatory Markers, Functional Capacity and Clinical Outcomes in Patients With Left Ventricular Dysfunction After Coronary Artery Bypass Grafting

This study aims to analyze effects of three types of cardiac rehabilitation protocol on fuctional capacity, inflammatory markers, pulmonary function and clinical outcomes after coronary artery bypass grafting (CABG) in patients with left ventricular disfunction. Patients will be randomized and allocated in three groups according to type of exercise protocol: 1. walk; 2. cycle; 3. functional electrical stimulation.

Study Overview

• Status: Unknown
• Conditions: Disorder; Heart, Functional, Postoperative, Cardiac Surgery
• Intervention / Treatment: Other: Walking exercise; Other: Stationary cycling exercise; Other: Neuromuscular electrical stimulation

Detailed Description

Several studies have been demonstrated beneficial effects of exercise to minimize impact of CABG. However, there is no consensus on what kind of exercise is safe and effective for patients with left ventricular dysfunction.

Walking

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04023062
      • Recruiting
      • Federal University of São Paulo
      • Contact: Solange Guizilini, PhD; Phone Number: +5511982887753; Email: s_guizilini@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Coronary artery disease proven by coronary angiography;
• Elective CABG;
• No acute or chronic pulmonary disease;
• Patients after surgery, keep in spontaneous ventilation on first postoperative day;
• Absence of neurological, neuromuscular, musculoskeletal and osteoarticular incapacitating;
• Consent form signed for participation in the survey.

Exclusion Criteria:

• Inability to perform spirometry;
• Presence of acute lung disease or chronic;
• Surgical indication of urgency;
• Morbid obesity;
• Hemodynamics instability at the time of spirometry or during six minutes walking test;
• Intraoperative death or until the sixth postoperative day;
• Patients remaining in mechanical prolonged ventilation for more than 12 hours;
• Severe cardiac arrhythmia during application of assessment protocols and exercises (ventricular tachycardia, atrioventricular block second or degree) any other condition the investigator's discretion put the patient at increased risk with beginning of the year; Any change that may lead to failure of proposed protocols.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Walking exercise; Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs, stationary running and walking. The intensity of walk will be determined by the Borg's sujective effort perception scale - (modified from zero to 10). On first postoperative day, participants will perform exercises in supine position. From the second to the fifth postoperative day, they will perform progressive walking.	Other: Walking exercise; Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs, stationary running and walking. The intensity of walk will be determined by the Borg's sujective effort perception scale - (modified from zero to 10). On first postoperative day, participants will perform exercises in supine position. From the second to the fifth postoperative day, they will perform progressive walking.
Experimental: Stationary cycling exercise; Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs. From the first to the fifth postoperative day, they will perform progressive cycling exercise.The intensity of cycling will be determined by the Borg's sujective effort perception scale - (modified from zero to 10).	Other: Stationary cycling exercise; Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs. From the first to the fifth postoperative day, they will perform progressive cycling exercise.The intensity of cycling will be determined by the Borg's sujective effort perception scale - (modified from zero to 10).
Experimental: Neuromuscular electrical stimulation; Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs. From the first to the fifth postoperative day, quadriceps and gastrocnemius muscles will be percutaneous stimulated with the following parameters: Synchronic mode, 50Hz, 400uS, time on 10s, time off 20s, intensity as tolerated by the patient.	Other: Neuromuscular electrical stimulation; Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs. From the first to the fifth postoperative day, quadriceps and gastrocnemius muscles will be percutaneous stimulated with the following parameters: Synchronic mode, 50Hz, 400uS, time on 10s, time off 20s, intensity as tolerated by the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Capacity	Participants will be submitted to six minute walk test on preoperative period and sixth postoperative day (or before hospital discharge) to evaluate functional capacity. The test will be performed with a mobile device to measure metabolic response to exercise (Oxycon™ Mobile).	Up to ten days after surgery, at hospital discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory markers	Blood sample will be collected to measure inflammatory markers (TNF-alpha and interleukins) and to compare exercise effects on inflammatory response after surgery.	in-hospital postoperative period, up to ten days after surgery.

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Solange Guizilini, PhD, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 5, 2016

Study Record Updates

• Last Update Posted (Estimate): May 5, 2016
• Last Update Submitted That Met QC Criteria: May 3, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: coronary artery bypass; postoperative complications; physical fitness; left ventricular dysfunction; sistemic inflammatory response syndrome
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Left
• Other Study ID Numbers: 31295914.0.0000.5505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES