Virtual Reality Therapy Influence on Heart Rate Variability of Inpatients With COVID-19

NCT04537858 | Unknown

• 1 other identifier: 33244620.5.0000.5505
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The end of 2019 saw the emergence of a new human coronavirus (COVID-19) spread rapidly around the world and has a high degree of lethality. In more severe cases, patients remain in hospital inpatient units, under the care of the health team. To serve this population, it is important to use and develop potential tools to meet the demands of physical activity and improve cardiorespiratory fitness. In this sense, exposure therapies of virtual reality are promising and, although limited for this purpose, have been shown to be an adequate and equivalent alternative to traditional exercise programs. Fifty patients with confirmed diagnosis of COVID-19 will be evaluated in an inpatient unit at Hospital São Paulo, at Escola Paulista de Medicina, Universidade Federal de São Paulo (HSP - EPM/UNIFESP). After completing all the questionnaires and tests of the initial evaluation (Medical Research Council Scale, Visual Analogue Scale, BORG Scale, Brunel's Mood Scale, Satisfaction Scale and Heart Rate Variability - HRV), the individuals will be divided into two groups being Group A: Subjects with COVID-19 who will start the first day of the protocol with Virtual Reality tasks in the morning and then in the second period, in the afternoon, will perform the conventional exercises (n = 25); And Group B: Subjects with COVID-19 who will start the first day with conventional exercises in the morning and in the second period, in the afternoon, will perform activity with virtual reality (n = 25). After the application of therapies, final evaluations will be carried out. The rehabilitation protocol will be applied during all days of hospitalization. For the protocol, the Heart Rate Variability indices will be evaluated in three moments: (1) rest before the task, (2) during the intervention, (3) recovering from the intervention. The performance data during the activity in Virtual reality will also be evaluated. The results of this study will assist in assessing the response to rehabilitation therapies during hospitalization and the prognosis of these patients.

Conditions

COVID-19; Inpatient

Outcome Measures

Primary Outcomes (2)

• Heart Rate Variability

  Assessment of heart rate variability indices before, during and in the recovering of intervention in order to access autonomic behavior during both interventions and to access behavior of the disease while in the hospital unit.

  3 months

• Motor Skills

  Assessment of motor skills, such as improvement in accuracy and precision of movement provided by the games developed for rehabilitation. The variables will be coincident timing evaluation, motor learning variables and performance.

  3 months

Secondary Outcomes (4)

• Strength

  3 months

• Perceived Exertion

  3 months

• Satisfaction using the technology

  3 months

• Mood

  3 months

Study Arms (2)

Virtual reality therapy first

EXPERIMENTAL

Subjects with COVID-19 who will start the first day of the protocol with Virtual Reality tasks in the morning and then in the second period, in the afternoon, will perform the conventional exercises (n = 25)

Device: Virtual reality therapy first

Conventional therapy first

EXPERIMENTAL

Subjects with COVID-19 who will start the first day with conventional exercises in the morning and in the second period, in the afternoon, will perform activity with virtual reality (n = 25).

Device: Conventional therapy first

Interventions

Virtual reality therapy first DEVICE

First day of the protocol with Virtual Reality intervention in the morning and conventional intervention in the afternoon

Virtual reality therapy first

Conventional therapy first DEVICE

First day of the protocol with conventional intervention in the morning and Virtual Reality intervention in the afternoon

Conventional therapy first

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatients with confirmed diagnosis of COVID-19.

You may not qualify if:

• Cardiac arrhythmias and atrioventricular block,
• Congenital anomalies, such as congenital heart disease,
• Pulmonary malformations,
• Drugs that interfere with SNA, such as anti-arrhythmic drugs.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Federal University of São Paulo: collaborator

Study Sites (1)

Comitê de Ética da Universidade Federal

São Paulo, 04.023-900, Brazil

Location

Related Publications (1)

• da Silva TD, de Oliveira PM, Dionizio JB, de Santana AP, Bahadori S, Dias ED, Ribeiro CM, Gomes RA, Ferreira M, Ferreira C, de Moraes IAP, Silva DMM, Barnabe V, de Araujo LV, Santana HBR, Monteiro CBM. Comparison Between Conventional Intervention and Non-immersive Virtual Reality in the Rehabilitation of Individuals in an Inpatient Unit for the Treatment of COVID-19: A Study Protocol for a Randomized Controlled Crossover Trial. Front Psychol. 2021 Feb 24;12:622618. doi: 10.3389/fpsyg.2021.622618. eCollection 2021.

  PMID: 33716889 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Talita D da Silva, Ph.D.

  Universidade Federal de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 3, 2020
• Study Start: June 18, 2020
• Primary Completion: August 20, 2020
• Study Completion: December 1, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)