- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04789512
Respiratory Muscle Strength in Volleyball Players Suffered From COVID-19
March 29, 2021 updated by: Zeliha ÇELİK, Gazi University
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
42
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Çankaya
-
Ankara, Çankaya, Turkey, 06490
- Gazi University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 35 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Female volleyball players
Description
Inclusion Criteria:
- having passed at least 30 days after the Polymerase Chain Reaction (PCR) test turned negative
- willing to participate in the study
Exclusion Criteria:
- having a history of chronic lung disease
- unwilling to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Covid-19 players
Female volleyball players with Covid-19
|
Respiratory muscle strength, pulmonary functions and body composition were evaluated in volleyball players
|
non-Covid-19 players
Female volleyball players with non Covid-19
|
Respiratory muscle strength, pulmonary functions and body composition were evaluated in volleyball players
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory muscle strength
Time Frame: 10 minute
|
Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device.
|
10 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FEV1
Time Frame: 5 minute
|
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.
|
5 minute
|
FVC
Time Frame: 5 minute
|
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
|
5 minute
|
FEV1/FVC
Time Frame: 5 minute
|
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.
|
5 minute
|
PEF
Time Frame: 5 minute
|
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.
|
5 minute
|
FEF2575
Time Frame: 5 minute
|
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.
|
5 minute
|
Fat mass
Time Frame: 2 minute
|
Fat mass will be evaluated using TANITA bioelectrical impedance analysis.
|
2 minute
|
Fat mass percent
Time Frame: 2 minute
|
Fat mass percent will be evaluated using TANITA bioelectrical impedance analysis.
|
2 minute
|
Fat-free mass
Time Frame: 2 minute
|
Fat-free mass will be evaluated using TANITA bioelectrical impedance analysis.
|
2 minute
|
Body mass index
Time Frame: 2 minute
|
Body mass index will be evaluated using TANITA bioelectrical impedance analysis.
|
2 minute
|
Predicted muscle mass
Time Frame: 2 minute
|
Predicted muscle mass will be evaluated using TANITA bioelectrical impedance analysis.
|
2 minute
|
Symptom severity perceptions
Time Frame: 1 minute
|
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.
|
1 minute
|
Performance situations perceptions
Time Frame: 1 minute
|
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.
|
1 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Actual)
March 26, 2021
Study Completion (Actual)
March 29, 2021
Study Registration Dates
First Submitted
March 6, 2021
First Submitted That Met QC Criteria
March 8, 2021
First Posted (Actual)
March 9, 2021
Study Record Updates
Last Update Posted (Actual)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 29, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-189
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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