Evaluation of Physical and Functional Status in Patients With COVID-19 in Long Term

NCT ID: NCT04836767

Last Updated: 2022-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-16

Study Completion Date

2022-02-03

Brief Summary

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The reason the investigators want to do this research; Especially after Covid-19 infection, no research has been found on functional status in the long term. Therefore, in our study, the investigators aimed to evaluate exercise capacity, functional status, peripheral muscle strength, balance, anxiety and depression level, consciousness, work productivity, pain, fear of movement, and quality of life in patients with Covid-19 and to compare them with healthy individuals who have not had COVID-19.

Detailed Description

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In our study, the investigators aimed to evaluate long-term exercise capacity, functional status, peripheral muscle strength, balance, anxiety and depression level, cognitive status, pain, kinesophobia and quality of life in patients with COVID-19, and to compare them with healthy individuals who have not had COVID-19. Our second goal; It is the evaluation of the relationship between long-term exercise capacity, pain, kinesiophobia, peripheral muscle strength, balance, anxiety and depression level, cognitive status and quality of life in individuals with COVID-19. It will also be examined whether these parameters change according to the post-COVID functional restriction level.

3\. Materials and Methods of the Research: 3.1. The place of the study: Cardiopulmonary Rehabilitation Unit of Hacettepe University Faculty of Physical Therapy and Rehabilitation and Hacettepe University Faculty of Medicine Department of General Internal Medicine

3.2. Time of the study: It is planned to collect data and write the study between February 2021 and February 2022.

3.3. Research population, sample, research group:

The population of the study is individuals who have passed the diagnosis of COVID-19 for at least 12 weeks and healthy individuals who have not had COVID-19.

The sample of the study is individuals in the long-term after the diagnosis of COVID-19 at least 12 weeks after the diagnosis of COVID-19 in Hacettepe University Adult Hospital who meet the inclusion criteria and volunteer to participate in the study, and healthy individuals who have not had COVID-19.

Study Design:

Individuals meeting the inclusion criteria will be included in the study. The study will be conducted with people between the ages of 18-65, whose education level is at least primary school, and whose local language is Turkish. A total of 40 participants, 20 healthy without COVID-19, and 20 with at least 12 weeks past the diagnosis of COVID-19, will be included in the study. The guidance of the participants will be provided by the relevant physicians of the General Internal Medicine Unit of Hacettepe University Internal Diseases Department.

In accordance with the COVID-19 pandemic precautions, social distance rules will be followed in the tests to be carried out with individuals, care will be taken to use masks, and the materials to be used in tests and measurements will be disinfected before and after use.

COVID-19 Group Inclusion Criteria

* Having been diagnosed with COVID-19 at least 12 weeks ago,
* Being literate,
* Being in the age range of 18-65,
* Volunteering to participate in research,
* To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes),
* Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity.

COVID-19 Group Exclusion Criteria

* Those with an ICU hospitalization history due to the diagnosis of COVID-19,
* Recent myocardial infarction and pulmonary embolism.
* Having accompanying chronic diseases,
* Those who have any orthopedic or neurological disorders that will prevent walking,
* Another COVID-19 PCR Test positivity in the last 12 weeks,
* Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders,

Healthy Group Inclusion Criteria

* Not having COVID-19,
* Being literate,
* Being in the age range of 18-65,
* Volunteering to participate in research.

The Criteria for Not Including the Healthy Group in the Study

* Those who have any orthopedic or neuromuscular disorders that will prevent walking,
* Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests.

Individuals participating in the study will be informed verbally and in writing about the study protocol and informed consent form will be obtained.

Conditions

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Corona Virus Infection Covid19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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people with a history of COVID-19

COVID-19 Group Inclusion Criteria

* Having been diagnosed with COVID-19 at least 12 weeks ago,
* Being literate,
* Being in the age range of 18-65,
* Volunteering to participate in research,
* To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes),
* Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity.

COVID-19 Group Exclusion Criteria

* Those with an ICU hospitalization history due to the diagnosis of COVID-19,
* Recent myocardial infarction and pulmonary embolism.
* Having accompanying chronic diseases,
* Those who have any orthopedic or neurological disorders that will prevent walking,
* Another COVID-19 PCR Test positivity in the last 12 weeks,
* Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders,

No interventions assigned to this group

healthy people

Healthy Group Inclusion Criteria

* Not having COVID-19,
* Being literate,
* Being in the age range of 18-65,
* Volunteering to participate in research. The Criteria for Not Including the Healthy Group in the Study
* Those who have any orthopedic or neuromuscular disorders that will prevent walking,
* Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Having been diagnosed with COVID-19 at least 12 weeks ago,
* Being literate,
* Being in the age range of 18-65,
* Volunteering to participate in research,
* To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes),
* Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity.

* Not having COVID-19,
* Being literate,
* Being in the age range of 18-65,
* Volunteering to participate in research. The Criteria for Not Including the Healthy Group in the Study
* Those who have any orthopedic or neuromuscular disorders that will prevent walking,
* Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests.

Exclusion Criteria

* Recent myocardial infarction and pulmonary embolism.
* Having accompanying chronic diseases,
* Those who have any orthopedic or neurological disorders that will prevent walking,
* Another COVID-19 PCR Test positivity in the last 12 weeks,
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Ebru Calik Kutukcu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülay Sain-Guven, Professor

Role: STUDY_DIRECTOR

Hacettepe University, Faculty of Medicine

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31.

Reference Type RESULT
PMID: 32475821 (View on PubMed)

Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.

Reference Type RESULT
PMID: 32085846 (View on PubMed)

Zhao H, Shen D, Zhou H, Liu J, Chen S. Guillain-Barre syndrome associated with SARS-CoV-2 infection: causality or coincidence? Lancet Neurol. 2020 May;19(5):383-384. doi: 10.1016/S1474-4422(20)30109-5. Epub 2020 Apr 1. No abstract available.

Reference Type RESULT
PMID: 32246917 (View on PubMed)

Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.

Reference Type RESULT
PMID: 32064853 (View on PubMed)

Belli S, Balbi B, Prince I, Cattaneo D, Masocco F, Zaccaria S, Bertalli L, Cattini F, Lomazzo A, Dal Negro F, Giardini M, Franssen FME, Janssen DJA, Spruit MA. Low physical functioning and impaired performance of activities of daily life in COVID-19 patients who survived hospitalisation. Eur Respir J. 2020 Oct 15;56(4):2002096. doi: 10.1183/13993003.02096-2020. Print 2020 Oct.

Reference Type RESULT
PMID: 32764112 (View on PubMed)

Other Identifiers

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GO21-178

Identifier Type: -

Identifier Source: org_study_id

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