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

NCT02763774 | Unknown DMC

• 1 other identifier: 31295914.0.0000.5505
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Keywords

coronary artery bypass; sistemic inflammatory response syndrome; left ventricular dysfunction; postoperative complications; physical fitness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Inflammatory markers

  in-hospital postoperative period, up to ten days after surgery.

Study Arms (3)

Walking exercise

EXPERIMENTAL

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

Stationary cycling exercise

EXPERIMENTAL

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

Neuromuscular electrical stimulation

EXPERIMENTAL

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

Interventions

Walking exercise OTHER

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.

Walking exercise

Stationary cycling exercise OTHER

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).

Stationary cycling exercise

Neuromuscular electrical stimulation OTHER

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.

Neuromuscular electrical stimulation

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04023062, Brazil

RECRUITING

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Postoperative Complications

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Solange Guizilini, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Solange Guizilini, PhD

CONTACT

+5511982887753; s_guizilini@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: May 5, 2016
• Study Start: June 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2017
• Last Updated: May 5, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)