The Effect of Virtual Reality Exercises on Patients With Post-SARS-CoV-2 Syndrome

The Effect of Virtual Reality Exercises on Pain, Cardiopulmonary Functional Capacity and Quality of Life in Patients With Post-COVID Syndrome

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19
• Intervention / Treatment: Other: Virtual Realty Exercises; Other: conventional exercises; Other: Aerobic exercises

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.

• Study Type: Interventional
• Enrollment (Anticipated): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sivas, Turkey, 58050
    • Sivas Cumhuriyet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Realty; Participants will play a motion-controlled video game with Microsoft XBox One Kinect for 30 minutes, three days a week, for 8 weeks and lower and upper extremity stretching, strengthening and endurance exercises	Other: Virtual Realty Exercises; motion-controlled video game; Other: conventional exercises; stretching, strengthening and endurance exercises
Active Comparator: Conventional; Participants will do aerobic exercises for 30 minutes, three days a week, for 8 weeks and lower and upper extremity stretching, strengthening and endurance	Other: conventional exercises; stretching, strengthening and endurance exercises; Other: Aerobic exercises; cycling activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
visual Analogue Scale	8th week

Secondary Outcome Measures

Outcome Measure	Time Frame
hospital anxiety and depression scale-Depression	0th and 8th week
hospital anxiety and depression scale-Anxiety	0th and 8th week
Fatigue severity scale	0th and 8th week
Short Form-12	0th and 8th week
6 minutes walking test	0th and 8th week

Collaborators and Investigators

• Sponsor: Cumhuriyet University
• Investigators: Principal Investigator: Musa Polat, Cumhuriyet University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): January 30, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: SivasCumhuriyetUniversity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The plan will be shared by the corresponding author at the submission stage if requested.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No