Covid19NCT04789512
Respiratory Muscle Strength in Volleyball Players Suffered From COVID-19
An observational study of Covid19, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
In literature, there is no data evaluating respiratory functions in volleyball players during Covid-19 pandemic. The aim of this study is to evaluate and compared pulmonary functions, respiratory muscle strength, body compositions and performance situations perceptions in female volleyball players with Covid-19 and… Read more about this study
- Who is it for?
- Ages 15 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Respiratory functions
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 29 Mar 2021
- 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 15 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Female volleyball players
Who may be able to join
- having passed at least 30 days after the Polymerase Chain Reaction (PCR) test turned negative
- willing to participate in the study
Who cannot join
- having a history of chronic lung disease
- unwilling to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Respiratory Muscle Strength and Pulmonary Functions in Volleyball Players Suffering From Covid-19
In literature, there is no data evaluating respiratory functions in volleyball players during Covid-19 pandemic. The aim of this study is to evaluate and compared pulmonary functions, respiratory muscle strength, body compositions and performance situations perceptions in female volleyball players with Covid-19 and non-Covid-19.
- Conditions
- Covid19
- Being tested
- Respiratory functions
- Keywords
- respiratory muscles, pulmonary functions
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory functionsOther
Respiratory muscle strength, pulmonary functions and body composition were evaluated in volleyball players
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 players | Female volleyball players with Covid-19 Receives: Other: Respiratory functions | |
| non-Covid-19 players | Female volleyball players with non Covid-19 Receives: Other: Respiratory functions |
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 mouth pressure device.
Measured: 10 minute
Secondary outcomes (12)
FEV1
Pulmonary function tests will be performed using a spirometry according to the American Thoracic Society and European Respiratory Society criteria. FEV1 will be evaluated. The percentage of predicted value <70% will be expressed as abnormal.
Measured: 5 minute
FVC
Pulmonary function tests will be performed using a spirometry according to the American Thoracic Society and European Respiratory Society criteria. FVC will be evaluated. The percentage of predicted value <70% will be expressed as abnormal
Measured: 5 minute
FEV1/FVC
Pulmonary function tests will be performed using a spirometry according to the American Thoracic Society and European Respiratory Society criteria. FEV1/FVC will be evaluated.
Measured: 5 minute
PEF
Pulmonary function tests will be performed using a spirometry according to the American Thoracic Society and European Respiratory Society criteria. PEF will be evaluated. The percentage of predicted value <70% will be expressed as abnormal.
Measured: 5 minute
FEF2575
Pulmonary function tests will be performed using a spirometry according to the American Thoracic Society and European Respiratory Society criteria. FEF2575 will be evaluated. The percentage of predicted value <50% will be expressed as abnormal.
Measured: 5 minute
Fat mass
Fat mass will be evaluated using TANITA bioelectrical impedance analysis.
Measured: 2 minute
Fat mass percent
Fat mass percent will be evaluated using TANITA bioelectrical impedance analysis.
Measured: 2 minute
Fat-free mass
Fat-free mass will be evaluated using TANITA bioelectrical impedance analysis.
Measured: 2 minute
Body mass index
Body mass index will be evaluated using TANITA bioelectrical impedance analysis.
Measured: 2 minute
Predicted muscle mass
Predicted muscle mass will be evaluated using TANITA bioelectrical impedance analysis.
Measured: 2 minute
Symptom severity perceptions
Symptom severity perceptions will be evaluated Numeric Rating Scale.The severity of symptoms perceptions related to Covid are scored 0-10 point. Higher scores indicate higher severity of symptoms.
Measured: 1 minute
Performance situations perceptions
Performance situations perceptions will be evaluated Numeric Rating Scale. Performance situations perceptions of all players are also scored 0-10 point. Higher scores indicate greater performance.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Mar 2021
- Primary completion26 Mar 2021
- Study completion29 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha ÇELİK, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789512
- Sponsor's protocol ID
- 2021-189
- Status last verified
- Mar 2021
- First submitted
- 6 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Celik Z, Guzel NA, Kafa N, Kokturk N. Respiratory muscle strength in volleyball players suffered from COVID-19. Ir J Med Sci. 2022 Oct;191(5):1959-1965. doi: 10.1007/s11845-021-02849-z. Epub 2021 Nov 8.
PubMed 34748144
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Respiratory Muscle Strength and Pulmonary Functions in Volleyball Players Suffering From Covid-19
- ClinicalTrials.gov ID
- NCT04789512
- Acronym / sponsor ID
- 2021-189
- Conditions
- Covid19
- Keywords
- respiratory muscles, pulmonary functions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 29 Mar 2021 (actual)
- First posted
- 9 Mar 2021 (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.
In literature, there is no data evaluating respiratory functions in volleyball players during Covid-19 pandemic. The aim of this study is to evaluate and compared pulmonary functions, respiratory muscle strength, body compositions and performance situations perceptions in female volleyball players with Covid-19 and non-Covid-19.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-19 players | – | Other: Respiratory functionsFemale volleyball players with Covid-19 |
| non-Covid-19 players | – | Other: Respiratory functionsFemale volleyball players with non Covid-19 |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Female volleyball players
Key inclusion criteria (2 listed)
- having passed at least 30 days after the Polymerase Chain Reaction (PCR) test turned negative
- willing to participate in the study
Key exclusion criteria (2 listed)
- having a history of chronic lung disease
- unwilling to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory functionsRespiratory muscle strength, pulmonary functions and body composition were evaluated in volleyball players | Other | Covid-19 players, non-Covid-19 players |
Primary outcome
Respiratory muscle strength
Time frame: 10 minute
Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device.
12 secondary outcomes
FEV1
Time frame: 5 minute
FVC
Time frame: 5 minute
FEV1/FVC
Time frame: 5 minute
PEF
Time frame: 5 minute
FEF2575
Time frame: 5 minute
Fat mass
Time frame: 2 minute
Fat mass percent
Time frame: 2 minute
Fat-free mass
Time frame: 2 minute
Body mass index
Time frame: 2 minute
Predicted muscle mass
Time frame: 2 minute
Symptom severity perceptions
Time frame: 1 minute
Performance situations perceptions
Time frame: 1 minute
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 1 Apr 2021.
- Derived from this study: PubMed 34748144Celik Z, Guzel NA, Kafa N, Kokturk N. Respiratory muscle strength in volleyball players suffered from COVID-19. Ir J Med Sci. 2022 Oct;191(5):1959-1965. doi: 10.1007/s11845-021-02849-z. Epub 2021 Nov 8.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19, run by Gazi 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 2 inclusion and 2 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 1 Apr 2021. 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: 10 minute). 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 NCT04789512, which also lists 1 linked publication.
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 1 Apr 2021.