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

Disorder; Heart, Functional, Postoperative, Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02763774
• Other study ID #: 31295914.0.0000.5505
• Status: Recruiting
• Phase: N/A
• First received: April 13, 2016
• Last updated: May 3, 2016
• Start date: June 2014
• Est. completion date: June 2017

Study information

• Verified date: May 2016
• Source: Federal University of São Paulo
• Contact: Solange Guizilini, PhD
• Phone: +5511982887753
• Email: s_guizilini[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorder; Heart, Functional, Postoperative, Cardiac Surgery
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

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.
• 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).
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	No