Influence of Virtual Reality on Myocardial Revascularization

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03350971
• Other study ID #: 2075500
• Status: Completed
• Phase: N/A
• First received: November 12, 2017
• Last updated: March 16, 2018
• Start date: January 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: March 2018
• Source: Universidade Metodista de Piracicaba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Other:
• Virtual reality training
training with Wii games, ergometer exercise, ambulation, standing exercises
• Control
chest physical therapy exercises

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas Gaspar Viana	Belém	Pará

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Metodista de Piracicaba

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

da Costa Torres D, Dos Santos PM, Reis HJ, Paisani DM, Chiavegato LD. Effectiveness of an early mobilization program on functional capacity after coronary artery bypass surgery: A randomized controlled trial protocol. SAGE Open Med. 2016 Dec 14;4:20503121 — View Citation

Faber AW, Patterson DR, Bremer M. Repeated use of immersive virtual reality therapy to control pain during wound dressing changes in pediatric and adult burn patients. J Burn Care Res. 2013 Sep-Oct;34(5):563-8. doi: 10.1097/BCR.0b013e3182777904. — View Citation

Sibilla A, Nydahl P, Greco N, Mungo G, Ott N, Unger I, Rezek S, Gemperle S, Needham DM, Kudchadkar SR. Mobilization of Mechanically Ventilated Patients in Switzerland. J Intensive Care Med. 2017 Jan 1:885066617728486. doi: 10.1177/0885066617728486. [Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac autonomic modulation	Avaliation during aplication of protocol (1 week) of heart rate variability on influence of autonomus nervous system on cardiac function	7 days