Clinical trial NCT03350971: Influence of Virtual Reality on Myocardial Revascularization
Official title: Influence of Training With Virtual Reality on Myocardial Revascularization: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: virtual reality
physical therapy
myocardial revascualrization
Lead sponsor: Universidade Metodista de Piracicaba
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 75
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cardiac autonomic modulation
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Hospital de Clínicas Gaspar Viana
state: Pará
Study officials:
affiliation: Universidade do Estado do Pará
name: Rodrigo S Rocha, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. 2020 Jan;35(1):55-62. doi: 10.1177/0885066617728486. Epub 2017 Aug 29.
citation: 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;4:2050312116682256. doi: 10.1177/2050312116682256. eCollection 2016.