Long-Term Respiratory Muscle Strength in Young COVID-19 Patients

NCT ID: NCT05381714

Last Updated: 2023-04-25

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-04-21

Brief Summary

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The coronavirus disease 2019 (COVID-19) is a highly contagious disorder caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 is a multisystem disease and therefore presents a variety of symptoms in the acute phase, such as fever, dry cough, fatigue, sore throat, loss of taste or smell, shortness of breath, nasal congestion, chest pain, muscle or joint pain, headache, and nausea.

COVID-19 primarily affects the respiratory functions of individuals. Although this situation is more difficult in hospitalized patients, it also causes severe effects in individuals who recover with home medication. It is thought that this damage caused by COVID-19 may cause permanent effects on individuals in the long term. During the COVID-19 period, individuals also had to maintain an inactive lifestyle due to quarantine. This decrease in physical activity capacity also causes permanent damage to the respiratory functions of individuals. In addition, studies have focused on this population, as COVID-19 usually affects older individuals. However, considering that young people are also exposed to the COVID-19 virus, the effect on respiratory functions in these individuals should also be examined. Combined with the available information on pulmonary functions, there is insufficient evidence about extrapulmonary features in post-COVID-19 patients who survive mild illness in the long term. It is also necessary to examine whether there is permanent damage to extrapulmonary features such as peripheral muscle strength in these individuals.

Therefore, in our study, it is aimed to examine the long-term results of respiratory functions, respiratory muscle strength and peripheral muscle strength of young individuals who recovered from COVID-19 and recovered from mild disease.

Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients

Post-COVID-19 Functional Status (Post-COVID-19 Functional Status Scale), respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), peripheral muscle strength (dynamometer), physical activity level (International Physical Activity Questionnaire), fatigue (Modified Borg Scale), shortness of breath (Modified Borg Scale) will be evaluated.

No interventions assigned to this group

Control

Respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), peripheral muscle strength (dynamometer), physical activity level (International Physical Activity Questionnaire), fatigue (Modified Borg Scale), shortness of breath (Modified Borg Scale) will be evaluated.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Patients:

* diagnosed with COVID-19, with a positive polymerase chain reaction (PCR) test
* at least six months ago (long term)
* non-hospitalization due to COVID-19
* non-smoker / for ex-smokers with 10 pack x years or less of smoking
* not continuing any regular physical activity program

Controls:

* non-smoker / for ex-smokers with 10 pack x years or less of smoking,
* not continuing any regular physical activity program
* willing to participate to the study

Exclusion Criteria

* receiving inpatient or intensive care treatment due to COVID-19
* having acute infection
* previous pulmonary resection or cardiac surgery
* having lung or heart comorbidities such as asthma
* chronic obstructive pulmonary disease (COPD) and heart failure
* uncontrolled hypertension
* history of malignancy
* neurological disease (e.g., Alzheimer, Multiple Sclerosis, Parkinson)
* rheumatologic diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karabuk University

OTHER

Sponsor Role lead

Responsible Party

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Musa Güneş

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Musa GÜNEŞ, MsC

Role: STUDY_CHAIR

Karabuk University

Metehan YANA, PhD

Role: PRINCIPAL_INVESTIGATOR

Karabuk University

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

Role: STUDY_DIRECTOR

Gazi University

Locations

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Karabuk University

Karabük, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Boutou AK, Georgopoulou A, Pitsiou G, Stanopoulos I, Kontakiotis T, Kioumis I. Changes in the respiratory function of COVID-19 survivors during follow-up: A novel respiratory disorder on the rise? Int J Clin Pract. 2021 Oct;75(10):e14301. doi: 10.1111/ijcp.14301. Epub 2021 May 17.

Reference Type BACKGROUND
PMID: 33932073 (View on PubMed)

van Kessel SAM, Olde Hartman TC, Lucassen PLBJ, van Jaarsveld CHM. Post-acute and long-COVID-19 symptoms in patients with mild diseases: a systematic review. Fam Pract. 2022 Jan 19;39(1):159-167. doi: 10.1093/fampra/cmab076.

Reference Type BACKGROUND
PMID: 34268556 (View on PubMed)

Guler SA, Ebner L, Aubry-Beigelman C, Bridevaux PO, Brutsche M, Clarenbach C, Garzoni C, Geiser TK, Lenoir A, Mancinetti M, Naccini B, Ott SR, Piquilloud L, Prella M, Que YA, Soccal PM, von Garnier C, Funke-Chambour M. Pulmonary function and radiological features 4 months after COVID-19: first results from the national prospective observational Swiss COVID-19 lung study. Eur Respir J. 2021 Apr 29;57(4):2003690. doi: 10.1183/13993003.03690-2020. Print 2021 Apr.

Reference Type BACKGROUND
PMID: 33419891 (View on PubMed)

Plaza M, Sevilla GGP. Respiratory muscle sequelae in young university students infected by coronavirus disease 2019: an observational study. Rev Assoc Med Bras (1992). 2022 Feb;68(2):245-249. doi: 10.1590/1806-9282.20211040.

Reference Type BACKGROUND
PMID: 35239890 (View on PubMed)

Tanriverdi A, Savci S, Kahraman BO, Ozpelit E. Extrapulmonary features of post-COVID-19 patients: muscle function, physical activity, mood, and sleep quality. Ir J Med Sci. 2022 Jun;191(3):969-975. doi: 10.1007/s11845-021-02667-3. Epub 2021 Jun 2.

Reference Type BACKGROUND
PMID: 34080125 (View on PubMed)

Lund Berven L, Selvakumar J, Havdal L, Stiansen-Sonerud T, Einvik G, Leegaard TM, Tjade T, Michelsen AE, Mollnes TE, Wyller VBB. Inflammatory Markers, Pulmonary Function, and Clinical Symptoms in Acute COVID-19 Among Non-Hospitalized Adolescents and Young Adults. Front Immunol. 2022 Feb 9;13:837288. doi: 10.3389/fimmu.2022.837288. eCollection 2022.

Reference Type BACKGROUND
PMID: 35222429 (View on PubMed)

Gunes M, Yana M, Guclu MB. Physical activity levels respiratory and peripheral muscle strength and pulmonary function in young post-COVID-19 patients : A cross-sectional study. Wien Klin Wochenschr. 2023 May;135(9-10):251-259. doi: 10.1007/s00508-023-02204-5. Epub 2023 Apr 28.

Reference Type DERIVED
PMID: 37115337 (View on PubMed)

Other Identifiers

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POST-COVID

Identifier Type: -

Identifier Source: org_study_id

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