- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04983394
The Effect of Virtual Reality Exercises on Patients With Post-COVID-19 Condition
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sivas, Turkey (Türkiye), 58050
- Sivas Cumhuriyet University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Realty
Virtual reality exercises were implemented semi-immersively in the Kinect Sports Rivals program via the Microsoft Xbox One Kinect game console and Kinect V2 infrared camera.
Participants were positioned 2 meters away from a 55-inch LCD screen in a well-lit room.
Motion-controlled video games, including tennis, bowling, soccer, target shooting, climbing, and jet ski racing, were played against a virtual opponent, starting at a basic difficulty level and increasing in difficulty based on the participant's ability to defeat their opponent.
Game transitions and difficulty adjustments were provided by the physical therapist.
Participants performed plyometric movements such as jumping and shooting, as well as limb and spine movements, to direct the avatar and ensured the coordination of their movements.
|
motion-controlled video game
|
|
Active Comparator: Conventional
Flexibility exercises were performed during the warm-up and cool-down periods of aerobic exercise for 3-5 minutes, consisting of static and dynamic upper and lower extremity stretching exercises in standing and sitting positions. Neuromuscular exercises were performed on the Bosu ball and balance board with eyes open and closed, using one or both feet. Aerobic exercise using a bicycle ergometer was performed for 20-30 minutes, depending on patient tolerance, starting at 60% of the age-determined maximum heart rate and increasing by 5% every 2 weeks (75% in the last 2 weeks). Strengthening exercises were performed for 10-15 minutes using dumbbells or sandbags targeting the large muscles of the upper and lower extremities. Initially, one set of strengthening exercises was performed with 8 repetitions targeting 6 different muscles at 50% of 1 RM intensity. Depending on patient tolerance, the exercise intensity was increased weekly to 70%, the number of muscles worked to 10, the number o |
aerobic, strength, stretching, and neuromuscular exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
visual Analogue Scale
Time Frame: 8th week
|
8th week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
hospital anxiety and depression scale-Depression
Time Frame: 0th and 8th week
|
0th and 8th week
|
|
hospital anxiety and depression scale-Anxiety
Time Frame: 0th and 8th week
|
0th and 8th week
|
|
Fatigue severity scale
Time Frame: 0th and 8th week
|
0th and 8th week
|
|
Short Form-12
Time Frame: 0th and 8th week
|
0th and 8th week
|
|
6 minutes walking test
Time Frame: 0th and 8th week
|
0th and 8th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Musa Polat, Cumhuriyet University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SivasCumhuriyetUniversity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Covid19
-
Anavasi DiagnosticsNot yet recruiting
-
Ain Shams UniversityRecruiting
-
Israel Institute for Biological Research (IIBR)Completed
-
Colgate PalmoliveCompleted
-
Christian von BuchwaldCompleted
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdActive, not recruiting
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitatsspital ZurichEnrolling by invitation
-
Alexandria UniversityCompleted
Clinical Trials on Virtual Realty Exercises
-
Riphah International UniversityRecruiting
-
Hacettepe UniversityCompletedGonarthrosis; PrimaryTurkey
-
Cairo UniversityNot yet recruiting
-
Camilo Jose Cela UniversityCompleted
-
Ankara City Hospital BilkentCompletedFlexor Tendon Rupture | Tendon Injury - HandTurkey
-
Timothy UhlUniversity of Kentucky; Commonwealth Hand and Physical TherapyCompletedDistal Radius Fracture | Flexor Tendon Rupture | Chronic Regional Pain SyndromeUnited States
-
Riphah International UniversityRecruiting
-
Kocaeli UniversitySakarya University of Applied SciencesCompletedQuality of Life | Pain | Range of Motion | Virtual RealityTurkey (Türkiye)
-
Riphah International UniversityEnrolling by invitationParkinson DiseasePakistan
-
University of HailCompletedLow Back Pain | Low Back Pain, MechanicalSaudi Arabia