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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04983394
Other study ID # SivasCumhuriyetUniversity
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date May 1, 2022

Study information

Verified date March 2022
Source Cumhuriyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 63
Est. completion date May 1, 2022
Est. primary completion date January 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Virtual Realty Exercises
motion-controlled video game
Aerobic exercises
cycling activity
conventional exercises
stretching, strengthening and endurance exercises

Locations

Country Name City State
Turkey Sivas Cumhuriyet University Sivas

Sponsors (1)

Lead Sponsor Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary visual Analogue Scale 8th week
Secondary hospital anxiety and depression scale-Depression 0th and 8th week
Secondary hospital anxiety and depression scale-Anxiety 0th and 8th week
Secondary Fatigue severity scale 0th and 8th week
Secondary Short Form-12 0th and 8th week
Secondary 6 minutes walking test 0th and 8th week
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