Pulmonary and Extrapulmonary Impairments in Patients With Post COVID-19

COVID-19 Clinical Trial

Official title:

Investigation of Oxygen Consumption Chronotropic Response and Physical Activity Level in Patients With Post COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05381727
• Other study ID #: Gazi University90
• Status: Recruiting
• Start date: May 15, 2022
• Est. completion date: December 20, 2024

Study information

• Verified date: June 2024
• Source: Gazi University
• Contact: Meral BOSNAK GÜÇLÜ, Prof. Dr.
• Phone: +903122162647
• Email: meralbosnak[@]gazi.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Patients who had diagnosed with COVID-19 and participants who do not have any diagnosed disease will be evaluated in this study. Twenty-five patients with post COVID-19 and 25 age- and sex-matched healthy controls will be included according to inclusion and exclusion criteria. All assessments will be completed in two days. Oxygen consumption, physical activity level, chronotropic response, pulmonary function, functional exercise capacity, respiratory and peripheral strength, inspiratory muscle endurance, functional dyspnea, fatigue perception and quality of life will be investigated in patients with COVID-19 and compared with age- and sex-matched healthy controls.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 20, 2024
• Est. primary completion date: August 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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

• 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

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Turkey	Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. Erratum In: Lancet. 2020 Jan 30;: — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Pulmonary function	Dynamic lung volumes will be evaluated by using a spirometry according to the American Thoracic Society and European Respiratory Society criteria.	Second day
Secondary	Functional exercise capacity	Six-minute walk test will be used to evaluate functional exercise capacity. The test will be done according to American Thoracic Society and European Respiratory Society criteria.	Second day
Secondary	Respiratory muscle strength	Respiratory muscle strength will be assessed with mouth pressure device. Maximal inspiratory and expiratory pressure will be measured during the test.	Second day
Secondary	Peripheral muscle strength	Quadriceps femoris and shoulder abduction muscle strength will be measured by using hand-held dynamometer.	Second day
Secondary	Inspiratory muscle endurance	Inspiratory muscle endurance will be measured incremental threshold loading test, in which patients started an initial load of 30% of maximal inspiratory pressure and test load will be increased with among 10% of maximal inspiratory pressure every two minutes.	Second day
Secondary	Dyspnea	Dyspnea perception during the daily living activities will be evaluated by using London Chest Daily Living Activity Scale (Turkish version). The highest total score could be obtained from the scale was 75, which indicates significant limitation in daily living activities due to dyspnea perception.	First day
Secondary	Fatigue	Fatigue will be assessed with Fatigue Severity Scale (Turkish version). This scale includes 9 items and each item scores from 1 (strong disagreement) to 7 (strong agreement) point. Fatigue Severity Scale total score is calculates by deriving an arithmetic mean. Cut-score of over 4 means significant fatigue and higher score indicates more severe fatigue.	First day
Secondary	Life Quality	Quality of life will be assessed with Saint George Respiratory Questionnaire (SGRQ) (Turkish version). This questionnaire scores range from 0 to 100. The total highest score indicates poor quality of life.	First day
Secondary	Modified Borg Scale	Modified Borg Scale will be used to assess dyspnea and fatigue perception of patients during cardiopulmonary exercise training and six-minute walk test. This scale is graded between 0 (nothing at all) and 10 (very very hard).	During the exercise tests
Secondary	Functional status	Functional status of patients after COVID-19 will be evaluated with Post COVID-19 Functional Status Scale (PCFS), which was developed specifically for COVID patients. Limitation and improvement in the functional status of patients after COVID could be assessed with this scale. Functional status are graded from 0 (no functional limitations) to 4 (severe functional limitations) in the scale.	First day