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

NCT04836767 | Completed

• 1 other identifier: GO21-178
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Corona Virus Infection; Covid19

Keywords

COVID-19; SARS-CoV2; pandemic; post-COVID-19; exercise capacity

Outcome Measures

Primary Outcomes (1)

• Incremental shuttle walking test

  It assesses maximal exercise capacity.

  January,2021 - December,2021

Secondary Outcomes (9)

• Time up and Go Test

  January,2021 - December,2021

• Short form McGill-Melzack Pain Questionnaire

  January,2021 - December,2021

• Tampa Kinesophobia Questionnaire

  January,2021 - December,2021

• Hospital Anxiety and Depression Scale

  January,2021 - December,2021

• SF-36 Quality of Life Scale

  January,2021 - December,2021

Study Arms (2)

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,

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 32475821 RESULT

• 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.

  PMID: 32085846 RESULT

• 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.

  PMID: 32246917 RESULT

• 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.

  PMID: 32064853 RESULT

• 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.

  PMID: 32764112 RESULT

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gülay Sain-Guven, Professor

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 8, 2021
• Study Start: February 16, 2021
• Primary Completion: February 3, 2022
• Study Completion: February 3, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

TU (1)