- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04983394
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Sivas, Kalkun, 58050
- Sivas Cumhuriyet University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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
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motion-controlled video game
stretching, strengthening and endurance exercises
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Aktiv komparator: 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
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stretching, strengthening and endurance exercises
cycling activity
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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visual Analogue Scale
Tidsramme: 8th week
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8th week
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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hospital anxiety and depression scale-Depression
Tidsramme: 0th and 8th week
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0th and 8th week
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hospital anxiety and depression scale-Anxiety
Tidsramme: 0th and 8th week
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0th and 8th week
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Fatigue severity scale
Tidsramme: 0th and 8th week
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0th and 8th week
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Short Form-12
Tidsramme: 0th and 8th week
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0th and 8th week
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6 minutes walking test
Tidsramme: 0th and 8th week
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0th and 8th week
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Musa Polat, Cumhuriyet University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- SivasCumhuriyetUniversity
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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