NCT03350971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

November 12, 2017

Last Update Submit

March 16, 2018

Conditions

Myocardial Infarction

Keywords

virtual realityphysical therapymyocardial revascualrization

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Virtual reality training

EXPERIMENTAL

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

Other: Virtual reality training

Control

ACTIVE COMPARATOR

chest physical therapy

Other: Control

Interventions

Virtual reality trainingOTHER

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

Virtual reality training
ControlOTHER

chest physical therapy exercises

Control

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas Gaspar Viana

Belém, Pará, 66087-660, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 23970314BACKGROUND

  • 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.

    PMID: 28847238RESULT

  • 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.

    PMID: 28348739RESULT

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Rodrigo S Rocha, Doctor

    Universidade do Estado do Pará

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 12, 2017

First Posted

November 22, 2017

Study Start

January 1, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

March 20, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)