Clinical trial NCT04983394: The Effect of Virtual Reality Exercises on Patients With Post-SARS-CoV-2 Syndrome
Official title: The Effect of Virtual Reality Exercises on Pain, Cardiopulmonary Functional Capacity and Quality of Life in Patients With Post-COVID Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effectiveness of virtual reality exercises on pain, cardiopulmonary capacity, mood and quality of life in patients with post-COVID syndrome.

Detailed description: This study, which will be conducted in Sivas Cumhuriyet University, Physical Medicine and Rehabilitation Clinic, was diagnosed with COVID-19 from an oropharyngeal or nasopharyngeal swab sample more than 90 days ago with polymerase chain reaction, whose symptoms have continued since the diagnosis of COVID-19, and inpatient treatment. 63 adult female and male post-COVID syndrome patients who did not develop pneumonia or organ failure findings will be included. Those who have had acute myocardial infarction in the last 6 months, have cardiovascular system disease such as uncontrolled hypertension, arrhythmia, aneurysm, cardiac failure, have undergone fracture or orthopedic surgery in the last 3 months, have a known chronic respiratory system disease, cause widespread pain such as fibromyalgia syndrome Those who have a disease or cannot be mobilized independently will not be included in the study. The sample size was determined as d=0.80 α=0.05 p=0.80410 n=54 using the G\*Power 3.1.9.4 program. Considering the 15% drop-out risk, 63 patients were planned to be included.

Demographic data of all participants, including age, gender, height, weight and body mass index, and the time elapsed since the diagnosis of COVID-19 will be recorded. In addition, participants' pain intensity, functional capacity, general health status, mood, and fatigue levels will be evaluated.

Eligibility criteria: Inclusion Criteria:

* diagnosed with COVID-19 by polymerase chain reaction from an oropharyngeal or nasopharyngeal swab sample more than 90 days ago, whose symptoms have continued since the diagnosis of COVID-19

Exclusion Criteria:

* have been hospitalized due to COVID-19,
* have developed pneumonia or organ failure findings.
* have had an acute myocardial infarction in the last 6 months,
* have cardiovascular system disease such as uncontrolled hypertension, arrhythmia, aneurysm, cardiac failure,
* have undergone fracture or orthopedic surgery in the last 3 months,
* have a known chronic respiratory system disease,
* have widespread pain such as fibromyalgia syndrome

Primary outcomes:
measure: visual Analogue Scale
timeFrame: 8th week
Secondary outcomes:
measure: hospital anxiety and depression scale-Depression
timeFrame: 0th and 8th week
measure: hospital anxiety and depression scale-Anxiety
timeFrame: 0th and 8th week
measure: Fatigue severity scale
timeFrame: 0th and 8th week
measure: Short Form-12
timeFrame: 0th and 8th week
measure: 6 minutes walking test
timeFrame: 0th and 8th week
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
Study officials:
affiliation: Cumhuriyet University
name: Musa Polat
role: PRINCIPAL_INVESTIGATOR
References: