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HealthyNCT04957199

Physiotherapist Awareness in the Community

An observational study of Healthy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Healthy
How many people
1,550 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 May 2021to 15 Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Adult

Study population: It includes individuals with or without covid-19 who meet the inclusion criteria from different regions of Turkey.

Who may be able to join

  • 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.

Who cannot join

  • It was determined as having visual and auditory problems at a level preventing communication.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site, 1 recruiting
  • Istanbul University-Cerrahpasa

    Istanbul, 00034

    İpek Yeldan, +90 902 124 1452 ext. 8, ipek.yeldan@iuc.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Physiotherapist Awareness in the Community During the COVID-19 Pandemic Process

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

Read the detailed 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.

Conditions
Healthy
Keywords
COVID-19, Physiotherapist, Awareness, Physiotherapy
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Other

Study groups in NCT04957199
Study groupRoleWhat they receive
CommunityIndividuals with or without COVID-19 in society

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 25.05.2021/15.07.2021

Secondary outcomes (1)
  1. Demographic information

    Participants' age, gender, educational status and occupation were questioned.

    Measured: 25.05.2021/15.07.2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2021
  2. Study start25 May 2021
  3. Primary completion15 Jul 2021 (estimated)
  4. Study completion15 Jul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
1,550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04957199
Sponsor's protocol ID
E.38981562-900-62297
Status last verified
Jul 2021
First submitted
16 Jun 2021
Last updated
15 Jul 2021
Results posted
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32167524
  • 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.

    PubMed 32109013
  • 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.

    PubMed 31986264
  • 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.

    PubMed 32369030
  • 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.

    PubMed 24368884
  • 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 Dec 3;56(6):2002197. doi: 10.1183/13993003.02197-2020. Print 2020 Dec.

    PubMed 32817258
  • 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.

    PubMed 32799694
  • 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.

    PubMed 29944655
  • Goertz 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):00542-2020. doi: 10.1183/23120541.00542-2020. eCollection 2020 Oct.

    PubMed 33257910
  • 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.

    PubMed 32379637
  • 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.

    PubMed 32324968
  • 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.

    PubMed 32388326
  • 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.

    PubMed 32589718
  • 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.

    PubMed 31175337
  • 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.

    PubMed 32672029

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact İpek Yeldan (+90 902 124 1452 ext. 8, ipek.yeldan@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physiotherapist awareness in the process of COVID-19 (time frame: 25.05.2021/15.07.2021). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04957199, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.

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