Pulmonary and Extrapulmonary Impairments in Patients With Post COVID-19
NCT ID: NCT05381727
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2022-05-15
2024-12-20
Brief Summary
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Detailed Description
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Primary outcome measurements will be oxygen consumption (cardiopulmonary exercise test), chronotropic response (results of cardiopulmonary exercise test) and physical activity level (multi sensor activity device). Secondary outcome will be pulmonary function (spirometer), functional exercise capacity (six minute walk test), respiratory muscle strength (mouth pressure device), peripheral muscle (hand-held dynamometer) strength, inspiratory muscle endurance (incremental threshold loading test), dyspnea (London Chest Daily Living Activity Scale), fatigue (Fatigue Severity Scale) and quality of life (Saint George Respiratory Questionnaire) and functional status (Post-COVID-19 Functional Status Scale).
Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Patients with Post COVID-19
That group consists from patients who had diagnosed with COVID-19 by doctors.
Oxygen consumption using cardiopulmonary exercise test, physical activity level using multi-sensor activity monitor, pulmonary function using spirometer, functional exercise capacity with six minute walk test, respiratory muscle strength using mouth pressure device, peripheral muscle strength with hand held dynamometer, inspiratory muscle endurance using incremental threshold loading test, dyspnea with 'Turkish version of London Chest Daily Living Activity Scale', fatigue with 'Turkish version of Fatigue Severity Scale' and quality of life with 'Turkish version of Saint George Respiratory Questionnaire' will be evaluated in patient with post COVID-19. Chronotropic response will be assessed according to results of maximal exercise test. Besides, functional statu of patients will be evaluated with Turkish version of 'Post COVID-19 Functional Status Scale'.
No interventions assigned to this group
Healthy Group
That group consists from people who do not have any diagnosed disease.
Oxygen consumption using cardiopulmonary exercise test, physical activity level using multi-sensor activity monitor, pulmonary function using spirometer, functional exercise capacity with six minute walk test, respiratory muscle strength using mouth pressure device, peripheral muscle strength with hand held dynamometer, inspiratory muscle endurance using incremental threshold loading test, dyspnea with 'Turkish version of London Chest Daily Living Activity Scale', fatigue with 'Turkish version of Fatigue Severity Scale' and quality of life with 'Turkish version of Saint George Respiratory Questionnaire' will be evaluated in healthy controls.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* aged between 18-75 years
* diagnosed with COVID-19 before
* patients whose COVID-19 Polymerase Chain Reaction test turned negative or be negative already
* patients who are willing to participate in this study.
Healthy controls;
* aged between 18-75 years
* patients who are willing to participate in this study.
Exclusion Criteria
* body mass index \>35 kg/m2
* cancer, renal or hepatic diseases
* aortic stenosis, complex arrhythmia, aortic aneurysm
* serious neurological, neuromuscular, orthopedic, other systemic diseases or. other diseases affecting physical functions
* uncontrolled hypertension and/or diabetes mellitus, heart failure and cardiovascular disease
* acute pulmonary exacerbation, acute upper or lower respiratory tract infection
* cognitive impairment that causes difficulty in understanding and following exercise test instructions
* bulla formation in the lung
* participated in a planned exercise program in the last three months
* contraindication for exercise testing and/or exercise training according to the American College of Sports Medicine
Healthy controls;
* history of coronavirus disease
* history of smoke exposure below 10 packs\*years
* have any diagnosed chronic or systemic diseases
* have psychiatric disorder
* body mass index \>35 kg/m2
* cognitive impairment that causes difficulty in understanding and following exercise test instructions
* acute pulmonary exacerbation, acute upper or lower respiratory tract infection
18 Years
75 Years
ALL
Yes
Sponsors
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Gazi University
OTHER
Responsible Party
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Meral Boşnak Güçlü
Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic
Principal Investigators
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Ece BAYTOK, MsC.
Role: STUDY_CHAIR
Gazi University
Başak KAVALCI KOL, MsC.
Role: PRINCIPAL_INVESTIGATOR
Gazi University
Nilgün YILMAZ DEMİRCİ, Assoc.Prof.
Role: PRINCIPAL_INVESTIGATOR
Gazi University
Meral BOŞNAK GÜÇLÜ, Prof. Dr.
Role: STUDY_DIRECTOR
Gazi University
Locations
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Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic
Ankara, , Turkey (Türkiye)
Countries
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References
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Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
Mandal S, Barnett J, Brill SE, Brown JS, Denneny EK, Hare SS, Heightman M, Hillman TE, Jacob J, Jarvis HC, Lipman MCI, Naidu SB, Nair A, Porter JC, Tomlinson GS, Hurst JR; ARC Study Group. 'Long-COVID': a cross-sectional study of persisting symptoms, biomarker and imaging abnormalities following hospitalisation for COVID-19. Thorax. 2021 Apr;76(4):396-398. doi: 10.1136/thoraxjnl-2020-215818. Epub 2020 Nov 10.
Malik P, Patel K, Pinto C, Jaiswal R, Tirupathi R, Pillai S, Patel U. Post-acute COVID-19 syndrome (PCS) and health-related quality of life (HRQoL)-A systematic review and meta-analysis. J Med Virol. 2022 Jan;94(1):253-262. doi: 10.1002/jmv.27309. Epub 2021 Sep 7.
Ali AM, Kunugi H. Skeletal Muscle Damage in COVID-19: A Call for Action. Medicina (Kaunas). 2021 Apr 12;57(4):372. doi: 10.3390/medicina57040372.
Baytok E, Bosnak Guclu M, Kavalci Kol B, Yilmaz Demirci N. Oxygen consumption chronotropic response to maximal exercise and physical activity level in patients with post-COVID-19 and pulmonary involvement. Physiother Theory Pract. 2025 Jul 10:1-15. doi: 10.1080/09593985.2025.2528358. Online ahead of print.
Other Identifiers
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Gazi University90
Identifier Type: -
Identifier Source: org_study_id