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临床试验/NCT04983394
NCT04983394已完成不适用

Effect of Motion-Controlled Video Games-Based Virtual Reality Exercise On Pain, Fatigue, Mood, Functional Capacity, And Quality of Life in Patients With Post-Covid-19 Condition: A Randomized Controlled Trial

Cumhuriyet University2 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2021年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
79
试验地点
2
主要终点
visual Analogue Scale

研究概览

简要总结

This study aims to investigate (I) the effectiveness of motion-controlled video game-based VR exercises on pain, fatigue, functional capacity, mood, and quality of life in patients with PCC, and (II) to determine whether they are superior to conventional exercise.

详细描述

79 individuals aged 18-65 years who were diagnosed with COVID-19 with a PCR test result in an oropharyngeal or nasopharyngeal swab sample taken more than 90 days ago and who had PCC symptoms for at least eight weeks were included. Patients with PCC who had been hospitalized, had signs of pneumonia or organ failure, had suffered an acute myocardial infarction or orthopedic surgery within the last 2 years, had cardiovascular system diseases such as uncontrolled hypertension, arrhythmia, or cardiac insufficiency, had known chronic respiratory system diseases, those with conditions causing widespread pain such as fibromyalgia syndrome, those with primary any neurological system diseases, or those unable to mobilize for any reason were excluded from the study.

The same physiatrist systematically evaluated the sociodemographic data, medical history including the time elapsed since the diagnosis of COVID-19, the duration of PCC symptoms, and outcome measures (fatigue level, pain intensity, general health status, emotional state, functional capacity) through face-to-face interviews at the hospital, and recorded in a standardized form.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed with COVID-19 by polymerase chain reaction from an oropharyngeal or nasopharyngeal swab sample more than 90 days ago, and who had PCC symptoms for at least eight weeks

排除标准

  • have been hospitalized due to COVID-19,
  • have developed pneumonia or organ failure findings.
  • have had an acute myocardial infarction in the last 2 years,
  • have cardiovascular system disease such as uncontrolled hypertension, arrhythmia, aneurysm, cardiac failure,
  • have undergone fracture or orthopedic surgery in the last 2 years,
  • have a known chronic respiratory system disease,
  • have widespread pain such as fibromyalgia syndrome

结局指标

主要结局

visual Analogue Scale

时间窗: 8th week

次要结局

  • hospital anxiety and depression scale-Anxiety(0th and 8th week)
  • Fatigue severity scale(0th and 8th week)
  • 6 minutes walking test(0th and 8th week)
  • hospital anxiety and depression scale-Depression(0th and 8th week)
  • Short Form-12(0th and 8th week)

研究者

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

MUSA POLAT

Principal Investigator

Cumhuriyet University

研究点 (2)

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