COVID-19NCT05381714
Long-Term Respiratory Muscle Strength in Young COVID-19 Patients
An observational study of COVID-19, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 21 Apr 2023
- How long will I take part?
- 1 Day
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 54 patients with post-COVID-19 and 54 healthy individuals will be included.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- history of malignancy
- neurological disease (e.g., Alzheimer, Multiple Sclerosis, Parkinson)
- rheumatologic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-Term Respiratory and Peripheral Muscle Strength and Respiratory Function in Young COVID-19 Patients: A Cross-Sectional Study
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
- Medical subject headings
- COVID-19, Motor Activity, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Muscle Strength
Maximal inspiratory and expiratory muscle strength will be evaluated using portable mouth pressure device.
Measured: First Day
Secondary outcomes (11)
Pulmonary function (Forced vital capacity (FVC))
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced vital capacity (FVC) will be evaluated.
Measured: First Day
Pulmonary function (Forced vital capacity (FEV1))
Pulmonary function (Forced expiratory volume in the first second (FEV1)) [ Time Frame: First Day ] Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.
Measured: First Day
Pulmonary function (FEV1 / FVC)
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, FEV1 / FVC will be evaluated.
Measured: First Day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.
Measured: First Day
Pulmonary function (Peak flow rate (PEF))
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, peak flow rate (PEF) will be evaluated.
Measured: First Day
Peripheral Muscle Strength
Knee extensor muscle strength using portable hand held dynamometer will be evaluated.
Measured: Second Day
Peripheral Muscle Strength
Shoulder abductors muscle strength using portable hand held dynamometer will be evaluated.
Measured: Second Day
Post-COVID-19 Functional Status
The post-COVID functional status of individuals recovering from COVID-19 will be evaluated with the Post-COVID-19 Functional Status Scale (PCFS). A minimum of 0 (no functional limitations) and a maximum of 5 (death) points are taken from this scale, and as the score increases, the functional status worsens.
Measured: First Day
Shortness of breath
The Modified Borg Scale will be used to determine dyspnea perception during rest and activity.
Measured: First Day
Fatigue
The Modified Borg Scale will be used to assess fatigue. The lowest 0 points are "not at all" and the highest 10 points are "very severe" denoting fatigue
Measured: First Day
Physical Activity
Physical activity levels will be used assessed using International Physical Activity Questionnaire. Physical activity levels are classified as physically inactive (<600 MET min/week), low physical activity level (600-3000 MET min/week), and adequate physical activity level (>3000 MET min/week).
Measured: Second Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jan 2022
- Primary completion1 Jun 2022
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Güneş, Karabuk University
- Investigators
- Musa GÜNEŞ, MsC, Study chair, Karabuk UniversityMetehan YANA, PhD, Principal investigator, Karabuk UniversityMeral BOŞNAK GÜÇLÜ, Prof. Dr., Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381714
- Sponsor's protocol ID
- POST-COVID
- Status last verified
- Apr 2023
- First submitted
- 17 May 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33932073van 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.
PubMed 34268556Guler 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.
PubMed 33419891Plaza 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.
PubMed 35239890Tanriverdi 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.
PubMed 34080125Lund 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.
PubMed 35222429Gunes 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.
PubMed 37115337
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Respiratory and Peripheral Muscle Strength and Respiratory Function in Young COVID-19 Patients: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05381714
- Acronym / sponsor ID
- POST-COVID
- Conditions
- COVID-19
- Keywords
- COVID-19, Muscle Strength, pulmonary function, Physical activity, Dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 54 patients with post-COVID-19 and 54 healthy individuals will be included.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory Muscle Strength
Time frame: First Day
Maximal inspiratory and expiratory muscle strength will be evaluated using portable mouth pressure device.
11 secondary outcomes
Pulmonary function (Forced vital capacity (FVC))
Time frame: First Day
Pulmonary function (Forced vital capacity (FEV1))
Time frame: First Day
Pulmonary function (FEV1 / FVC)
Time frame: First Day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Time frame: First Day
Pulmonary function (Peak flow rate (PEF))
Time frame: First Day
Peripheral Muscle Strength
Time frame: Second Day
Peripheral Muscle Strength
Time frame: Second Day
Post-COVID-19 Functional Status
Time frame: First Day
Shortness of breath
Time frame: First Day
Fatigue
Time frame: First Day
Physical Activity
Time frame: Second Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 33932073Boutou 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.
- Background: PubMed 34268556van 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.
- Background: PubMed 33419891Guler 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.
- Background: PubMed 35239890Plaza 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.
- Background: PubMed 34080125Tanriverdi 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.
- Background: PubMed 35222429Lund 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.
- Derived from this study: PubMed 37115337Gunes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Musa GÜNEŞ, MsC study chair
Karabuk University
Metehan YANA, PhD principal investigator
Karabuk University
Meral BOŞNAK GÜÇLÜ, Prof. Dr. study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Karabuk University 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 10 inclusion and 9 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: finished, as of the sponsor's last update on 25 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Muscle Strength (time frame: First Day). 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 NCT05381714, which also lists 7 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 25 Apr 2023.