Covid19 Clinical Trial
Official title:
Understanding Exertional Dyspnea and Exercise Intolerance in COVID-19
NCT number | NCT04732663 |
Other study ID # | Pro00107436 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 4, 2021 |
Est. completion date | May 6, 2024 |
Verified date | May 2024 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A novel corona virus emerged in 2019 causing Corona Virus Disease 2019 (covid-19). In one year more than 80 000 000 cases worldwide were documented. Some patients experience symptoms, specifically shortness of breath, long after the viral infection has passed. These patients are colloquially known as "Covid-19 Long-Haulers" and it is currently unknown why symptoms remain after infection. Shortness of breath and exercise intolerance may be caused by corona virus infection, covid-19 therapy, and reduced physical activity. Exercise intolerance may be due to lung, heart, blood vessel and muscle changes. During infection, the corona virus appears to cause lung blood vessel and gas exchange surface damage. Early reports show heart dysfunction, secondary to pulmonary blood vessel dysfunction or damage. Critically, no data is available on lung blood vessel function or cardiac function during exercise. Moreover, no data are available to link persistent symptoms to physiology parameters. To better understand symptom persistence in Covid-19, the investigators aim to measure exercise tolerance and heart and lung function in covid-19 survivors and compare them to covid-19 free controls.
Status | Completed |
Enrollment | 64 |
Est. completion date | May 6, 2024 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Covid-19/Symptom status as defined under each group. Exclusion Criteria: 1. Previous diagnosis of pulmonary hypertension 2. Obesity (body mass index >30 kg/m2) 3. Absolute contraindication to exercise testing or an orthopedic limitation that may interfere with cardiopulmonary exercise testing |
Country | Name | City | State |
---|---|---|---|
Canada | Clinical Physiology Laboratory | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
Ackermann M, Mentzer SJ, Kolb M, Jonigk D. Inflammation and intussusceptive angiogenesis in COVID-19: everything in and out of flow. Eur Respir J. 2020 Nov 12;56(5):2003147. doi: 10.1183/13993003.03147-2020. Print 2020 Nov. — View Citation
Burel-Vandenbos F, Cardot-Leccia N, Passeron T. Pulmonary Vascular Pathology in Covid-19. N Engl J Med. 2020 Aug 27;383(9):886-887. doi: 10.1056/NEJMc2022068. Epub 2020 Jul 17. No abstract available. — View Citation
Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603. — View Citation
D'Alto M, Marra AM, Severino S, Salzano A, Romeo E, De Rosa R, Stagnaro FM, Pagnano G, Verde R, Murino P, Farro A, Ciccarelli G, Vargas M, Fiorentino G, Servillo G, Gentile I, Corcione A, Cittadini A, Naeije R, Golino P. Right ventricular-arterial uncoupling independently predicts survival in COVID-19 ARDS. Crit Care. 2020 Nov 30;24(1):670. doi: 10.1186/s13054-020-03385-5. — View Citation
Dhawan RT, Gopalan D, Howard L, Vicente A, Park M, Manalan K, Wallner I, Marsden P, Dave S, Branley H, Russell G, Dharmarajah N, Kon OM. Beyond the clot: perfusion imaging of the pulmonary vasculature after COVID-19. Lancet Respir Med. 2021 Jan;9(1):107-116. doi: 10.1016/S2213-2600(20)30407-0. Epub 2020 Nov 17. — View Citation
Ferretti G, Antonutto G, Denis C, Hoppeler H, Minetti AE, Narici MV, Desplanches D. The interplay of central and peripheral factors in limiting maximal O2 consumption in man after prolonged bed rest. J Physiol. 1997 Jun 15;501 ( Pt 3)(Pt 3):677-86. doi: 10.1111/j.1469-7793.1997.677bm.x. — View Citation
Gualtieri P, Falcone C, Romano L, Macheda S, Correale P, Arciello P, Polimeni N, Lorenzo A. Body Composition Findings by Computed Tomography in SARS-CoV-2 Patients: Increased Risk of Muscle Wasting in Obesity. Int J Mol Sci. 2020 Jun 30;21(13):4670. doi: 10.3390/ijms21134670. — View Citation
Hewitt J, Carter B, Vilches-Moraga A, Quinn TJ, Braude P, Verduri A, Pearce L, Stechman M, Short R, Price A, Collins JT, Bruce E, Einarsson A, Rickard F, Mitchell E, Holloway M, Hesford J, Barlow-Pay F, Clini E, Myint PK, Moug SJ, McCarthy K; COPE Study Collaborators. The effect of frailty on survival in patients with COVID-19 (COPE): a multicentre, European, observational cohort study. Lancet Public Health. 2020 Aug;5(8):e444-e451. doi: 10.1016/S2468-2667(20)30146-8. Epub 2020 Jun 30. — View Citation
Huang Y, Tan C, Wu J, Chen M, Wang Z, Luo L, Zhou X, Liu X, Huang X, Yuan S, Chen C, Gao F, Huang J, Shan H, Liu J. Impact of coronavirus disease 2019 on pulmonary function in early convalescence phase. Respir Res. 2020 Jun 29;21(1):163. doi: 10.1186/s12931-020-01429-6. — View Citation
Lang M, Som A, Carey D, Reid N, Mendoza DP, Flores EJ, Li MD, Shepard JO, Little BP. Pulmonary Vascular Manifestations of COVID-19 Pneumonia. Radiol Cardiothorac Imaging. 2020 Jun 18;2(3):e200277. doi: 10.1148/ryct.2020200277. eCollection 2020 Jun. — View Citation
Li Y, Li H, Zhu S, Xie Y, Wang B, He L, Zhang D, Zhang Y, Yuan H, Wu C, Sun W, Zhang Y, Li M, Cui L, Cai Y, Wang J, Yang Y, Lv Q, Zhang L, Xie M. Prognostic Value of Right Ventricular Longitudinal Strain in Patients With COVID-19. JACC Cardiovasc Imaging. 2020 Nov;13(11):2287-2299. doi: 10.1016/j.jcmg.2020.04.014. Epub 2020 Apr 28. — View Citation
Ma Y, Hou L, Yang X, Huang Z, Yang X, Zhao N, He M, Shi Y, Kang Y, Yue J, Wu C. The association between frailty and severe disease among COVID-19 patients aged over 60 years in China: a prospective cohort study. BMC Med. 2020 Sep 7;18(1):274. doi: 10.1186/s12916-020-01761-0. — View Citation
Malas MB, Naazie IN, Elsayed N, Mathlouthi A, Marmor R, Clary B. Thromboembolism risk of COVID-19 is high and associated with a higher risk of mortality: A systematic review and meta-analysis. EClinicalMedicine. 2020 Dec;29:100639. doi: 10.1016/j.eclinm.2020.100639. Epub 2020 Nov 20. — View Citation
McGuire DK, Levine BD, Williamson JW, Snell PG, Blomqvist CG, Saltin B, Mitchell JH. A 30-year follow-up of the Dallas Bedrest and Training Study: II. Effect of age on cardiovascular adaptation to exercise training. Circulation. 2001 Sep 18;104(12):1358-66. — View Citation
Merrill JT, Erkan D, Winakur J, James JA. Emerging evidence of a COVID-19 thrombotic syndrome has treatment implications. Nat Rev Rheumatol. 2020 Oct;16(10):581-589. doi: 10.1038/s41584-020-0474-5. Epub 2020 Jul 30. — View Citation
Myers J, Prakash M, Froelicher V, Do D, Partington S, Atwood JE. Exercise capacity and mortality among men referred for exercise testing. N Engl J Med. 2002 Mar 14;346(11):793-801. doi: 10.1056/NEJMoa011858. — View Citation
Oliveira RKF, Faria-Urbina M, Maron BA, Santos M, Waxman AB, Systrom DM. Functional impact of exercise pulmonary hypertension in patients with borderline resting pulmonary arterial pressure. Pulm Circ. 2017 Jul-Sep;7(3):654-665. doi: 10.1177/2045893217709025. Epub 2017 Jun 8. — View Citation
Quinn KL, Fralick M, Zipursky JS, Stall NM. Renin-angiotensin-aldosterone system inhibitors and COVID-19. CMAJ. 2020 May 19;192(20):E553-E554. doi: 10.1503/cmaj.200619. Epub 2020 Apr 24. No abstract available. — View Citation
Sanyaolu A, Okorie C, Marinkovic A, Patidar R, Younis K, Desai P, Hosein Z, Padda I, Mangat J, Altaf M. Comorbidity and its Impact on Patients with COVID-19. SN Compr Clin Med. 2020;2(8):1069-1076. doi: 10.1007/s42399-020-00363-4. Epub 2020 Jun 25. — View Citation
Sonnweber T, Sahanic S, Pizzini A, Luger A, Schwabl C, Sonnweber B, Kurz K, Koppelstatter S, Haschka D, Petzer V, Boehm A, Aichner M, Tymoszuk P, Lener D, Theurl M, Lorsbach-Kohler A, Tancevski A, Schapfl A, Schaber M, Hilbe R, Nairz M, Puchner B, Huttenberger D, Tschurtschenthaler C, Asshoff M, Peer A, Hartig F, Bellmann R, Joannidis M, Gollmann-Tepekoylu C, Holfeld J, Feuchtner G, Egger A, Hoermann G, Schroll A, Fritsche G, Wildner S, Bellmann-Weiler R, Kirchmair R, Helbok R, Prosch H, Rieder D, Trajanoski Z, Kronenberg F, Woll E, Weiss G, Widmann G, Loffler-Ragg J, Tancevski I. Cardiopulmonary recovery after COVID-19: an observational prospective multicentre trial. Eur Respir J. 2021 Apr 29;57(4):2003481. doi: 10.1183/13993003.03481-2020. Print 2021 Apr. — View Citation
Szekely Y, Lichter Y, Taieb P, Banai A, Hochstadt A, Merdler I, Gal Oz A, Rothschild E, Baruch G, Peri Y, Arbel Y, Topilsky Y. Spectrum of Cardiac Manifestations in COVID-19: A Systematic Echocardiographic Study. Circulation. 2020 Jul 28;142(4):342-353. doi: 10.1161/CIRCULATIONAHA.120.047971. Epub 2020 May 29. — View Citation
Tedjasaputra V, Bouwsema MM, Stickland MK. Effect of aerobic fitness on capillary blood volume and diffusing membrane capacity responses to exercise. J Physiol. 2016 Aug 1;594(15):4359-70. doi: 10.1113/JP272037. Epub 2016 May 12. — View Citation
Tedjasaputra V, van Diepen S, Phillips DB, Wong EYL, Bhutani M, Michaelchuk WW, Bryan TL, Stickland MK. Pulmonary capillary blood volume response to exercise is diminished in mild chronic obstructive pulmonary disease. Respir Med. 2018 Dec;145:57-65. doi: 10.1016/j.rmed.2018.10.015. Epub 2018 Oct 19. — View Citation
Vonk Noordegraaf A, Galie N. The role of the right ventricle in pulmonary arterial hypertension. Eur Respir Rev. 2011 Dec;20(122):243-53. doi: 10.1183/09059180.00006511. — View Citation
Zhao YM, Shang YM, Song WB, Li QQ, Xie H, Xu QF, Jia JL, Li LM, Mao HL, Zhou XM, Luo H, Gao YF, Xu AG. Follow-up study of the pulmonary function and related physiological characteristics of COVID-19 survivors three months after recovery. EClinicalMedicine. 2020 Aug;25:100463. doi: 10.1016/j.eclinm.2020.100463. Epub 2020 Jul 15. — View Citation
Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5. — View Citation
* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Physical Activity | Self reported physical activity and accelerometer based physical activity monitoring (Fitbit). | Step count averaged across 5 days | |
Other | Thigh Composition | Muscle and adipose thickness, muscle echo intensity (ultrasound). | Assessed at rest and are measured in triplicate | |
Other | Frailty | Questionnaire assessment (Edmonton Frail Scale, FRAIL Scale, Frailty Phenotype, or Clinical Frail Scale) | Assessed upon admission | |
Other | Quality of Life (QoL) | Health related quality of life as assessed using the Post Covid Functional Scale, EQ5D-5L | Assessed upon admission | |
Other | Hemoglobin | Blood hemoglobin concentration (finger prick) | Pre and post exercise trial | |
Other | Muscle Oxygenation | Quadriceps muscle oxygenation during exercise measured by near infrared spectroscopy. | Assessed at rest and are measured in triplicate | |
Other | Blood Biomarkers | Biomarkers of inflammation, organ and tissue damage including CRP, INFg, BNP, CK. | Assessed upon admission | |
Primary | Peak Oxygen Uptake (VO2peak) | Staged cardiopulmonary exercise test | Within 20-30 seconds of completion of trial | |
Primary | Peak Cardiac Output (Qpeak) | Impedance cardiography derived Qpeak from staged CPET | Within 20-30 seconds of completion of trial | |
Primary | Pulmonary Capillary Blood Volume (Vc) | Multiple fraction of inspired oxygen DLCO derived pulmonary capillary blood volume at rest and during exercise. | Averaged across trials | |
Secondary | Ventilatory Efficiency (VE/VCO2) | Measured from expired gas analysis during cardiopulmonary exercise testing. | Averaged across trial | |
Secondary | Dyspnea | Measured using the modified Borg scale (1-10, 10=maximal dyspnea), perceived dyspnea during cardiopulmonary exercise testing. Scale = 1-10 |
Assessed every 2-minutes until completion of the exercise trial; anticipating ~10-14 minute tests | |
Secondary | Membrane Diffusion Capacity (Dm) | Measured at rest and during exercise using the multiple fraction of inspired oxygen DLCO technique. | Averaged across trials | |
Secondary | Pulmonary Artery Systolic Pressure (PASP) | Echocardiography estimated pulmonary artery systolic pressure. | Assessed for five consecutive cardiac cycles and are measured in triplicate during the cardiac ultrasound trial | |
Secondary | Right Ventricular Function | Reported as PASP:TAPSE (tricuspid annular plane systolic excursion) measured using echocardiography. | Assessed for five consecutive cardiac cycles and are measured in triplicate during the cardiac ultrasound trial | |
Secondary | Left Ventricular Stiffness | Estimated from E/e' using echocardiography. | Assessed for five consecutive cardiac cycles and are measured in triplicate during the cardiac ultrasound trial |
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