Influence of Virtual Reality on Myocardial Revascularization

March 16, 2018 updated by: Rodrigo Santiago Barbosa Rocha, Phd, Universidade Metodista de Piracicaba

Influence of Training With Virtual Reality on Myocardial Revascularization: Randomized Clinical Trial

Coronary artery disease is a dysfunction characterized by the narrowing of the coronary arteries in due to the accumulation of atheromatous plaques. The surgery of myocardial revascularization is a surgical procedure of choice performed in individuals with to improve symptoms and survival. Cardiovascular surgeries of this size in an extended time of rest after the procedure. Such immobility may have repercussions to the functionality of the individual. Thus, the early mobilization with the use of reality in the Intensive Care Units (ICU) emerges as a potential means of of complications in the postoperative period of cardiac surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be performed at the ICU coronary artery of the Hospital de Clínicas Gaspar Viana de Belém-Pará. 40 volunteers will participate in the study.

preoperative period of myocardial revascularization. The oxidative stress (by the method called Optical Morphology by Oxidative Stress, using capillary blood drops), the modulation autonomic heart rate (with a Polar® model RS800CX) and motor function (through the Medical Research Council scale), before and after the application of protocol for cardiac rehabilitation with ergometer, virtual reality and ambulation. Volunteers will be randomized into a control group who receive the cardiac rehabilitation protocol from the hospital and the Early Mobilization Group, which will receive the cardiac rehabilitation protocol plus virtual reality training using Wii video game from Nintendo.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pará
      • Belém, Pará, Brazil, 66087-660
        • Hospital de Clínicas Gaspar Viana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male patients over 50 years of age to 80 years
  • Body Mass Index (BMI) between 20 and 30 BMI kg / m2
  • Candidates for elective and conventional myocardial revascularization surgery
  • Hemodynamic stability with or without the use of positive inotropes

Exclusion Criteria:

  • Patients with previous pulmonary diseases, with ejection fraction below 35% or greater than 54%
  • Undergo concomitant surgeries and who underwent surgical reoperation and intraoperative death
  • Also excluded are those with motor and neurological deficits, as well as contraindications for performing 6MWT
  • orthopedic limitations
  • unstable angina, HR> 120 bpm at rest, systolic pressure> 180 mmHg or diastolic> 100 mmHg.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality training
Training with ergometer associated with training on wii videogame during 4 days
Other: Virtual reality training
training with Wii games, ergometer exercise, ambulation, standing exercises
Active Comparator: Control
chest physical therapy
Other: Control
chest physical therapy exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac autonomic modulation
Time Frame: 7 days
Avaliation during aplication of protocol (1 week) of heart rate variability on influence of autonomus nervous system on cardiac function
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Metodista de Piracicaba

Investigators

  • Principal Investigator: Rodrigo S Rocha, Doctor, Universidade Do Estado Do Pará

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

November 12, 2017

First Submitted That Met QC Criteria

November 20, 2017

First Posted (Actual)

November 22, 2017

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 16, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2075500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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