Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04957199
Other study ID # E.38981562-900-62297
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 25, 2021
Est. completion date July 15, 2021

Study information

Verified date July 2021
Source Istanbul University-Cerrahpasa
Contact Ipek Yeldan
Phone +90 902 124 1452
Email ipek.yeldan@iuc.edu.tr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to determine the level of awareness of the physiotherapist in the society during the COVID-19 process.


Description:

COVID-19 is an infectious disease that affects the respiratory system caused by the new SARS-Cov-2 corona virus, which originated in Wuhan, China, in late 2019. On January 30, 2020, the World Health Organization (WHO) declared it is an epidemic, and on March 11, 2020, it was described as a COVID-19 pandemic. Respiratory problems such as fever (89%), cough (68%), fatigue (38%), phlegm production (34%) and/or shortness of breath (19%) may be considered as the primary symptoms seen in individuals with COVID-19 . Other rare symptoms include hemoptiziness, loss of appetite, nausea, vomiting, diarrhea, abdominal pain, muscle pain, headache, odor or taste disorder, conjunctivitis, and confusion. Complications common due to COVID-19 include acute respiratory distress syndrome, acute kidney damage, anemia, heart failure and secondary infection. The most common cause of death was reported to be multiple organ dysfunction syndrome followed by cardiac arrest, respiratory failure, and acute respiratory distress syndrome. Symptoms seen in COVID-19 fall within the scope of pulmonary rehabilitation. Pulmonary rehabilitation provides benefits for all patients who suffer from any chronic respiratory disease, have reduced lung function, are symptomatic and have exertion intolerance, despite an optimal pharmacological treatment. The importance of rehabilitation after COVID-19 is emphasized according to the International Classification of Functionality, Disability and Health. Recent reports indicated that 80% of cases were asymptomatic or mild, 15% severe (oxygen required infection) and 5% were critical (respiratory and life support). Intensive care unit (ICU) admission rates are approximately 5%. Oxygen therapy is required in approximately 42% of hospitalized patients. Hospitalized COVID-19 patients often have comorbidities such as cardiovascular disease and diabetes and have long hospital stays. Some COVID-19 patients have physical impairments that can be exacerbated by prolonged inactivity, including muscle weakness, neurological disorder and/or malnutrition. In-hospital rehabilitation is proposed to tackle these problems and solve them. A series of cases from Wuhan, China, reported that 20% of hospitalized patients with approved COVID-19 required intensive care. Similar figures were reported in Italy-Lombardy, where 16% of COVID-19 patients require intensive care unit (ICU) care. Early rehabilitation intervention prevents the complications that may arise because of hospitalization in ICU related to COVID-19 and can reduce or even eliminate the negative effects on daily life of patients. Respiratory muscle atrophy and diaphragm dysfunction are quite common in patients requiring long-term bed rest and mechanical ventilation. It has been documented that the respiratory function during the admission has a negative correlation with mortality and the duration of treatment in ICU is shortened from an average of 20.4 days to 12.8 days after the improvement in respiratory function. Multiple symptoms may occur approximately 3 months after the onset of symptoms in hospitalized or non-hospitalized patients due to COVID-19. This situation indicates its existence as "post-COVID-19 syndrome". It emphasizes the presence of insufficiently met healthcare services and the need for rehabilitation in patient groups who have experienced "mild" or "severe" COVID-19. Physiotherapy and rehabilitation have an important line in these health services. Liu et al. In their study, it was reported that there was a significant improvement in respiratory function, quality of life and anxiety levels in patients as a result of the rehabilitation program that included 6-week respiratory muscle training, secretion excretion, diaphragm training, stretching exercises and home exercises after COVID-19. In the light of this information, the importance of physiotherapists in treatment is inevitable in improving the functional disorders of individuals with COVID-19 in both acute and chronic periods. Considering the studies that mention that lifestyle diseases such as obesity, insulin resistance, diabetes and hypertension are associated with increased risk of hospitalization and death, there are suggestions that the presence of high aerobic capacity may be protective in a severe COVID-19 picture. In line with the examinations made in the USA and Italy; The presence of at least one lifestyle-related comorbidity of individuals infected with COVID-19 is 94% in the USA, while this figure is 99% in Italy. Improving lifestyle behaviors, preventing, and controlling comorbidities; It has been proven to reduce the risk of premature death and the progression of chronic diseases, improve quality of life, and provide significant economic benefits. Physiotherapists, who play a major role in preventive measures, may not be able to prevent catching COVID-19 with exercise training, but they can provide a shorter recovery with less severe symptoms. Due to the risk of transmission during the COVID-19 period, it is recommended to use telerehabilitation-based approaches to implement exercise training and rehabilitation program. Studies on telerehabilitation have emphasized the importance of telerehabilitation-based approaches in the physiotherapy and rehabilitation practices of individuals with both COVID-19 positive and COVID-19 negative diseases. According to the study conducted in post-COVID-19 patients in Hubei, China; when asked about the rehabilitation awareness and willingness information source, 68.9% of the patients stated that they were not aware of rehabilitation before, the rest were from medical personnel (22.1%), online media (22.1%), and family or friends (1.4%) reported that they received information about rehabilitation. This is evidence of insufficient awareness in patients. After obtaining the basic information about rehabilitation, 38.9% of the patients wanted to receive rehabilitation treatment while they were in the hospital, 45.4% agreed to receive rehabilitation after discharge, and only 15.7% are not currently seeking rehabilitation. Based on these data, it can be said that it is necessary to provide the society with access to rehabilitation information. There are many studies and reviews on the role of physiotherapists during COVID-19. From the beginning of 2020, we know how important rehabilitation activities are in the care of COVID-19 patients, in recently published recommendations. Therefore, there is an urgent need to increase academic and public awareness of physiotherapy and its different fields of action, work environments. Special emphasis should also be placed on raising awareness of physiotherapy considering the current challenges faced.


Recruitment information / eligibility

Status Recruiting
Enrollment 1550
Est. completion date July 15, 2021
Est. primary completion date July 15, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - It was determined to accept to participate in the study. - To be native in Turkish. - To have an internet supported phone / computer in or near him/herself to use the internet by him/herself. - To have a level of cooperation to understand the evaluations. Exclusion Criteria: - It was determined as having visual and auditory problems at a level preventing communication.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa I?stanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (16)

Corhay JL, Dang DN, Van Cauwenberge H, Louis R. Pulmonary rehabilitation and COPD: providing patients a good environment for optimizing therapy. Int J Chron Obstruct Pulmon Dis. 2014;9:27-39. doi: 10.2147/COPD.S52012. Epub 2013 Dec 16. Review. — View Citation

Dean E, Jones A, Yu HP, Gosselink R, Skinner M. Translating COVID-19 Evidence to Maximize Physical Therapists' Impact and Public Health Response. Phys Ther. 2020 Aug 31;100(9):1458-1464. doi: 10.1093/ptj/pzaa115. — View Citation

Duggal NA, Niemiro G, Harridge SDR, Simpson RJ, Lord JM. Can physical activity ameliorate immunosenescence and thereby reduce age-related multi-morbidity? Nat Rev Immunol. 2019 Sep;19(9):563-572. doi: 10.1038/s41577-019-0177-9. Review. — View Citation

Goërtz YMJ, Van Herck M, Delbressine JM, Vaes AW, Meys R, Machado FVC, Houben-Wilke S, Burtin C, Posthuma R, Franssen FME, van Loon N, Hajian B, Spies Y, Vijlbrief H, van 't Hul AJ, Janssen DJA, Spruit MA. Persistent symptoms 3 months after a SARS-CoV-2 infection: the post-COVID-19 syndrome? ERJ Open Res. 2020 Oct 26;6(4). pii: 00542-2020. doi: 10.1183/23120541.00542-2020. eCollection 2020 Oct. — View Citation

Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28. — 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

Kumar A, Rahman M, Trivedi AN, Resnik L, Gozalo P, Mor V. Comparing post-acute rehabilitation use, length of stay, and outcomes experienced by Medicare fee-for-service and Medicare Advantage beneficiaries with hip fracture in the United States: A secondary analysis of administrative data. PLoS Med. 2018 Jun 26;15(6):e1002592. doi: 10.1371/journal.pmed.1002592. eCollection 2018 Jun. — View Citation

Li Z, Zheng C, Duan C, Zhang Y, Li Q, Dou Z, Li J, Xia W. Rehabilitation needs of the first cohort of post-acute COVID-19 patients in Hubei, China. Eur J Phys Rehabil Med. 2020 Jun;56(3):339-344. doi: 10.23736/S1973-9087.20.06298-X. — View Citation

Liu K, Zhang W, Yang Y, Zhang J, Li Y, Chen Y. Respiratory rehabilitation in elderly patients with COVID-19: A randomized controlled study. Complement Ther Clin Pract. 2020 May;39:101166. doi: 10.1016/j.ctcp.2020.101166. Epub 2020 Apr 1. — View Citation

Mohamed AA, Alawna M. Role of increasing the aerobic capacity on improving the function of immune and respiratory systems in patients with coronavirus (COVID-19): A review. Diabetes Metab Syndr. 2020 Jul - Aug;14(4):489-496. doi: 10.1016/j.dsx.2020.04.038. Epub 2020 Apr 28. Review. — View Citation

Polastri M, Lazzeri M, Jácome C, Vitacca M, Costi S, Clini E, Marques A. Rehabilitative practice in Europe: Roles and competencies of physiotherapists. Are we learning something new from COVID-19 pandemic? Pulmonology. 2021 Jul-Aug;27(4):283-285. doi: 10.1016/j.pulmoe.2020.12.014. Epub 2021 Jan 23. — View Citation

Sheehy LM. Considerations for Postacute Rehabilitation for Survivors of COVID-19. JMIR Public Health Surveill. 2020 May 8;6(2):e19462. doi: 10.2196/19462. — View Citation

Spruit MA, Holland AE, Singh SJ, Tonia T, Wilson KC, Troosters T. COVID-19: Interim Guidance on Rehabilitation in the Hospital and Post-Hospital Phase from a European Respiratory Society and American Thoracic Society-coordinated International Task Force. Eur Respir J. 2020 Aug 13. pii: 2002197. doi: 10.1183/13993003.02197-2020. [Epub ahead of print] — View Citation

Sun T, Guo L, Tian F, Dai T, Xing X, Zhao J, Li Q. Rehabilitation of patients with COVID-19. Expert Rev Respir Med. 2020 Dec;14(12):1249-1256. doi: 10.1080/17476348.2020.1811687. Epub 2020 Oct 12. — View Citation

Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum in: JAMA Intern Med. 2020 Jul 1;180(7):1031. — View Citation

Zbinden-Foncea H, Francaux M, Deldicque L, Hawley JA. Does High Cardiorespiratory Fitness Confer Some Protection Against Proinflammatory Responses After Infection by SARS-CoV-2? Obesity (Silver Spring). 2020 Aug;28(8):1378-1381. doi: 10.1002/oby.22849. Epub 2020 Jul 9. — View Citation

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Physiotherapist awareness in the process of COVID-19 The participants were asked question about physiotherapy through a questionnaire and the answers were recorded. Whether the participants received physiotherapy services before COVID-19, their awareness of the areas where physiotherapists work, whether they had COVID-19, and physiotherapist awareness during the COVID-19 process were questioned. 25.05.2021/15.07.2021
Secondary Demographic information Participants' age, gender, educational status and occupation were questioned. 25.05.2021/15.07.2021
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1