Influence of Virtual Reality on Myocardial Revascularization

NCT ID: NCT03350971

Last Updated: 2018-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-02-01

Brief Summary

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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

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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.

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Virtual reality training

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

Group Type EXPERIMENTAL

Virtual reality training

Intervention Type OTHER

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

Control

chest physical therapy

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

chest physical therapy exercises

Interventions

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Virtual reality training

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

Intervention Type OTHER

Control

chest physical therapy exercises

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Metodista de Piracicaba

OTHER

Sponsor Role lead

Responsible Party

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Rodrigo Santiago Barbosa Rocha, Phd

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rodrigo S Rocha, Doctor

Role: PRINCIPAL_INVESTIGATOR

Universidade do Estado do Pará

Locations

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Hospital de Clínicas Gaspar Viana

Belém, Pará, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 23970314 (View on PubMed)

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.

Reference Type RESULT
PMID: 28847238 (View on PubMed)

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.

Reference Type RESULT
PMID: 28348739 (View on PubMed)

Other Identifiers

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2075500

Identifier Type: -

Identifier Source: org_study_id

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