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

NCT05381714 | Completed

• 1 other identifier: POST-COVID
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Keywords

COVID-19; Muscle Strength; pulmonary function; Physical activity; Dyspnea

Outcome Measures

Primary Outcomes (1)

• Respiratory Muscle Strength

  Maximal inspiratory and expiratory muscle strength will be evaluated using portable mouth pressure device.

  First Day

Secondary Outcomes (11)

• Pulmonary function (Forced vital capacity (FVC))

  First Day

• Pulmonary function (Forced vital capacity (FEV1))

  First Day

• Pulmonary function (FEV1 / FVC)

  First Day

• Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))

  First Day

• Pulmonary function (Peak flow rate (PEF))

  First Day

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

54 patients with post-COVID-19 and 54 healthy individuals will be included.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Karabuk University

Karabük, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 33932073 BACKGROUND

• 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.

  PMID: 34268556 BACKGROUND

• 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.

  PMID: 33419891 BACKGROUND

• 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.

  PMID: 35239890 BACKGROUND

• 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.

  PMID: 34080125 BACKGROUND

• 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.

  PMID: 35222429 BACKGROUND

• 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.

  PMID: 37115337 DERIVED

MeSH Terms

Conditions

COVID-19; Motor Activity; Dyspnea

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Musa GÜNEŞ, MsC

  Karabuk University

  STUDY CHAIR

• Metehan YANA, PhD

  Karabuk University

  PRINCIPAL INVESTIGATOR

• Meral BOŞNAK GÜÇLÜ, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 19, 2022
• Study Start: January 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: April 21, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)