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

Primary Purpose

Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Walking exercise
Stationary cycling exercise
Neuromuscular electrical stimulation
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder; Heart, Functional, Postoperative, Cardiac Surgery focused on measuring coronary artery bypass, sistemic inflammatory response syndrome, left ventricular dysfunction, postoperative complications, physical fitness

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Federal University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Walking exercise

Stationary cycling exercise

Neuromuscular electrical stimulation

Arm Description

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.

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).

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
April 13, 2016
Last Updated
May 3, 2016
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02763774
Brief Title
Effects a Rehabilitation Program in Patients With Left Ventricular Dysfunction After Coronary Artery Bypass Grafting
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder; Heart, Functional, Postoperative, Cardiac Surgery
Keywords
coronary artery bypass, sistemic inflammatory response syndrome, left ventricular dysfunction, postoperative complications, physical fitness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Walking exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Stationary cycling exercise
Arm Type
Experimental
Arm Description
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).
Arm Title
Neuromuscular electrical stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Walking exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stationary cycling exercise
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Neuromuscular electrical stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional Capacity
Description
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).
Time Frame
Up to ten days after surgery, at hospital discharge.
Secondary Outcome Measure Information:
Title
Inflammatory markers
Description
Blood sample will be collected to measure inflammatory markers (TNF-alpha and interleukins) and to compare exercise effects on inflammatory response after surgery.
Time Frame
in-hospital postoperative period, up to ten days after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Solange Guizilini, PhD
Phone
+5511982887753
Email
s_guizilini@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Solange Guizilini, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023062
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Solange Guizilini, PhD
Phone
+5511982887753
Email
s_guizilini@yahoo.com.br

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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