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

NCT ID: NCT02763774

Last Updated: 2016-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-06-30

Brief Summary

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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

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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

Conditions

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Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Walking exercise

Intervention Type 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.

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).

Group Type EXPERIMENTAL

Stationary cycling exercise

Intervention Type 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).

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.

Group Type EXPERIMENTAL

Neuromuscular electrical stimulation

Intervention Type 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.

Interventions

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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.

Intervention Type 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).

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Solange Guizilini

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Solange Guizilini, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Solange Guizilini, PhD

Role: CONTACT

+5511982887753

Facility Contacts

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Solange Guizilini, PhD

Role: primary

+5511982887753

Other Identifiers

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31295914.0.0000.5505

Identifier Type: -

Identifier Source: org_study_id

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