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Influence of Virtual Reality on Myocardial Revascularization

Primary Purpose

Myocardial Infarction

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Virtual reality training

Control

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring virtual reality, physical therapy, myocardial revascualrization

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital de Clínicas Gaspar Viana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual reality training

Control

Arm Description

Training with ergometer associated with training on wii videogame during 4 days

chest physical therapy

Outcomes

Primary Outcome Measures

Cardiac autonomic modulation

Avaliation during aplication of protocol (1 week) of heart rate variability on influence of autonomus nervous system on cardiac function

Secondary Outcome Measures

Full Information

NCT ID

NCT03350971

First Posted

November 12, 2017

Last Updated

March 16, 2018

Sponsor

Universidade Metodista de Piracicaba

1. Study Identification

Unique Protocol Identification Number

NCT03350971

Brief Title

Influence of Virtual Reality on Myocardial Revascularization

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

January 1, 2017 (Actual)

Primary Completion Date

February 1, 2018 (Actual)

Study Completion Date

February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Metodista de Piracicaba

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

virtual reality, physical therapy, myocardial revascualrization

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized clinical trial

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Virtual reality training

Arm Type

Experimental

Arm Description

Training with ergometer associated with training on wii videogame during 4 days

Arm Title

Control

Arm Type

Active Comparator

Arm Description

chest physical therapy

Intervention Type

Other

Intervention Name(s)

Virtual reality training

Intervention Description

training with Wii games, ergometer exercise, ambulation, standing exercises

Intervention Type

Other

Intervention Name(s)

Control

Intervention Description

chest physical therapy exercises

Primary Outcome Measure Information:

Title

Cardiac autonomic modulation

Description

Avaliation during aplication of protocol (1 week) of heart rate variability on influence of autonomus nervous system on cardiac function

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rodrigo S Rocha, Doctor

Organizational Affiliation

Universidade do Estado do Pará

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Clínicas Gaspar Viana

City

Belém

State/Province

Pará

ZIP/Postal Code

66087-660

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23970314

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.

Results Reference

background

PubMed Identifier

28847238

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.

Results Reference

result

PubMed Identifier

28348739

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.

Results Reference

result

Learn more about this trial

Influence of Virtual Reality on Myocardial Revascularization

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