Pulmonary and Extrapulmonary Impairments in Patients With Post COVID-19

NCT05381727 | Completed

• 1 other identifier: Gazi University90
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary involvement and fibrosis could be seen in patients after COVID-19. Especially diffusion capacity, pulmonary function, exercise capacity and muscle strength have decreased in patients with COVID-19. Some symptom complaints of patients might continue after the disease, also. It has been shown that COVID-19 causes pulmonary involvement. However, the number of studies revealing the extent of pulmonary and extrapulmonary exposure due to COVID 19 comparing to healthy individuals is very limited, and has not been adequately investigated yet.

Conditions

COVID-19

Keywords

COVID-19; Oxygen consumption; Chronotropic response; Physical activity

Outcome Measures

Primary Outcomes (3)

• Oxygen consumption

  Maximal exercise capacity will be assessed with symptom limited cardiopulmonary exercise test on a treadmill at a progressively increasing speed and grade. Oxygen consumption will be measured during the test.

  First day

• Chronotropic response

  The chronotropic response will be assessed using the results of the symptom limited cardiopulmonary exercise test. The chronotropic incompetence will be named according to the chronotropic index calculated from the test result.

  First day

• Physical activity level

  Physical activity level will be evaluated with multi sensor activity device. Patients will be asked to wear the device for three consecutive days on weekdays.

  Second day

Secondary Outcomes (10)

• Pulmonary function

  Second day

• Functional exercise capacity

  Second day

• Respiratory muscle strength

  Second day

• Peripheral muscle strength

  Second day

• Inspiratory muscle endurance

  Second day

Study Arms (2)

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'.

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

At least 25 patients with COVID will be included in patients group and 25 healthy individuals will be included in control group.

You may qualify if:

• Patients;
• 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.

You may not qualify if:

• Patients;
• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 31986264 BACKGROUND

• 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.

  PMID: 33172844 BACKGROUND

• 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.

  PMID: 34463956 BACKGROUND

• 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.

  PMID: 33921429 BACKGROUND

• 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 Dec;41(12):2534-2548. doi: 10.1080/09593985.2025.2528358. Epub 2025 Jul 10.

  PMID: 40637260 DERIVED

MeSH Terms

Conditions

COVID-19; Motor Activity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Officials

• Ece BAYTOK, MsC.

  Gazi University

  STUDY CHAIR

• Başak KAVALCI KOL, MsC.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Nilgün YILMAZ DEMİRCİ, Assoc.Prof.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Meral BOŞNAK GÜÇLÜ, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 19, 2022
• Study Start: May 15, 2022
• Primary Completion: August 20, 2024
• Study Completion: December 20, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)