跳至主要内容
临床试验/NCT04537858
NCT04537858Unknown不适用

Analysis of the Influence of Rehabilitation With Virtual Reality on the Heart Rate Variability of Individuals Under Treatment of COVID-19 in a Hospital Unit.

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Motor Skills

研究概览

简要总结

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.

详细描述

To carry out this study, an experimental protocol will be used, where patients admitted to an inpatient unit of the São Paulo hospital will perform a rehabilitation protocol at two different times using virtual reality tasks and conventional therapies.

In the first moment, in the initial evaluation, only on the first day of care with the patient, the Medical Research Council Scale, Visual Analog Scale, BORG Scale, Brunel Mood Scale and Satisfaction Scale will be applied. At the end of the therapy, a BORG scale is applied to assess and monitor the patient's perception of effort. For the evaluation and characterization of the sample will be used:

Medical Research Council scale (MRC)

The Medical Research Council (MRC) was created in 1943, it is an instrument adapted to assess muscle strength in critically ill patients. The result is obtained through the evaluation of six movements of upper limbs (upper limbs) and lower limbs (lower limbs) and the strength is graded between 0 (plegia) to 5 points (normal strength). The maximum sum can reach 60 points, values below 48 are considered that the patient has muscle weakness.

Visual Analog Scale (EVA) The visual analog scale (VAS) is an instrument to assess the degree of pain in the patient, it consists of a 10 cm line that has, in general, the phrases "absence of pain and unbearable pain" as extremes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inpatients with confirmed diagnosis of COVID-19.

排除标准

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

结局指标

主要结局

Motor Skills

时间窗: 3 months

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.

Heart Rate Variability

时间窗: 3 months

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.

次要结局

  • Mood(3 months)
  • Strength(3 months)
  • Perceived Exertion(3 months)
  • Satisfaction using the technology(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Talita Dias da Silva

Researcher

University of Sao Paulo

研究点 (2)

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