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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02763774
Enrollment
45
Registered
2016-05-05
Start date
2014-06-30
Completion date
2017-06-30
Last updated
2016-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Keywords

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

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

Interventions

OTHERWalking 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.

OTHERStationary 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).

OTHERNeuromuscular 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.

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Functional CapacityUp to ten days after surgery, at hospital discharge.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

MeasureTime frameDescription
Inflammatory markersin-hospital postoperative period, up to ten days after surgery.Blood sample will be collected to measure inflammatory markers (TNF-alpha and interleukins) and to compare exercise effects on inflammatory response after surgery.

Countries

Brazil

Contacts

Primary ContactSolange Guizilini, PhD
s_guizilini@yahoo.com.br+5511982887753

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026