Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000376741
Ethics application status
Approved
Date submitted
28/02/2022
Date registered
3/03/2022
Date last updated
5/12/2022
Date data sharing statement initially provided
3/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Kinesiophobia, dyspnea, pain, fatigue, depression, anxiety, stress and balance in adolescent volleyball players who have had COVID-19
Scientific title
Kinesiophobia, dyspnea, pain, fatigue, depression, anxiety, stress and balance in adolescent volleyball players who have had COVID-19
Secondary ID [1] 306464 0
Nil known
Universal Trial Number (UTN)
U1111-1275-0760
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kinesiophobia 325315 0
Dyspnea 325316 0
Pain 325317 0
Depression 325318 0
Anxiety 325319 0
Stress
 325320 0
COVID-19 325321 0
Balance problem 325322 0
Condition category
Condition code
Infection 322710 322710 0 0
Other infectious diseases
Respiratory 322711 322711 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To present the effects of kinesiophobia, dyspnea, pain, fatigue, depression, anxiety, stress and balance parameters in adolescent volleyball players who have had COVID-19, by comparing them with adolescent volleyball players who have not had COVID-19. Kinesiophobia, dyspnea, pain, fatigue, depression, anxiety, stress and evaluation of the balance will be completed within a maximum of one hour.
Intervention code [1] 322895 0
Not applicable
Comparator / control treatment
Adolescent volleyball players without COVID-19 will be included as the control group.
Control group
Placebo

Outcomes
Primary outcome [1] 330508 0
Difference in kinesiophobia mean score which will be evaluated using Tampa Kinesiophobia Scale
Timepoint [1] 330508 0
at survey time
Secondary outcome [1] 406481 0
The difference in the mean score of the severity of fatigue to be assessed using the Fatigue Numerical Rating Scale
Timepoint [1] 406481 0
at survey time
Secondary outcome [2] 406482 0
Difference in mean scores of depression levels which will be evaluated using Depression Anxiety Stress-21 Scale
Timepoint [2] 406482 0
at survey time
Secondary outcome [3] 406483 0
Difference in mean scores of anxiety levels which will be evaluated using Depression Anxiety Stress-21 Scale
Timepoint [3] 406483 0
at survey time
Secondary outcome [4] 406484 0
Difference in mean scores of stress levels which will be evaluated using Depression Anxiety Stress-21 Scale
Timepoint [4] 406484 0
at survey time
Secondary outcome [5] 406485 0
Static balance will be evaluated with the balance test on one leg, and dynamic balance will be evaluated with the functional reach test. With the one-leg balance test, the time it stays in balance will be recorded in seconds. In the functional reach test, the distance between the starting point and the reaching point will be recorded and three attempts will be made and the average of the last two attempts will be taken.
Timepoint [5] 406485 0
at survey time
Secondary outcome [6] 406927 0
Difference in mean score for dyspnea severity to be assessed using the Modified Medical Research Council (MMRC) Scale
Timepoint [6] 406927 0
At survey time
Secondary outcome [7] 406928 0
The difference in the mean score of pain severity to be assessed using the Numerical Rating Scale (SDS)
Timepoint [7] 406928 0
at survey time

Eligibility
Key inclusion criteria
Inclusion criteria for volleyball players who have had COVID-19;
*Being in the 10-19 age range
*Having had COVID-19
* Volleyball players who volunteered to participate in the study
* Volleyball players who can understand and answer surveys
*COVID-19 diagnosis (Polymerase Chain Reaction (PCR) test result
volleyball players who are positive, have a negative PCR test result but are compatible with COVID-19 infection as a result of lung X-ray or lung tomography) and were discharged after recovery/home quarantine is over

Inclusion criteria for volleyball players who have not had COVID-19;
*Being in the 10-19 age range
* Volleyball players who volunteered to participate in the study
* Volleyball players who can understand and answer surveys
Minimum age
10 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for volleyball players who have had COVID-19;
*Any physical or mental disability/disease and/or cognitive
volleyball players with the disorder
*Volleyball players newly diagnosed with COVID-19, therefore quarantined at home or receiving treatment in hospital
* Volleyball players with suspected COVID-19

Exclusion criteria for those who have not had COVID-19;
* Volleyball players with any physical or mental disability
* Volleyball players with any acute or chronic infection and/or health problems
* Volleyball players who are in quarantine for any reason
*Having had COVID-19

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size required for the study was calculated using the GPower (G*Power 3.0.10 system) program. It was determined that at least 18 individuals should be included in the group of those with COVID-19 and at least 10 individuals in the healthy group in order for this study to reach an a value of 0.05, an effect size of 1.5, and a power of 95%, to determine the mean kinesiophobia score difference (9.1) between the two groups.
At the end of the study, statistical analyzes will be made using the SPSS 15.0 program. By using visual (histogram and probability graphs) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests), the conformity of all variables to normal distribution will be investigated. Descriptive analyzes will be given using frequency (n) and percentage (%) values for categorical variables, median, minimum and maximum values for non-normally distributed variables, mean and standard deviation (×±ss) for normally distributed variables.
The Independent Sample t test (Student t test) will be used to compare the variables that fit the normal distribution, the Mann-Whitney U test will be used to compare the data that do not fit, and the Chi-square test will be used to compare the uncountable data. The relationships between the non-normally distributed variables will be determined by Spearman and the relationships between the normally distributed variables will be determined by the Pearson correlation analysis method. The probability of error in statistical analysis will be determined as p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2022
Actual
30/05/2022
Date of last participant enrolment
Anticipated
Actual
31/08/2022
Date of last data collection
Anticipated
Actual
31/08/2022
Sample size
Target
28
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 24587 0
Turkey
State/province [1] 24587 0
Izmir

Funding & Sponsors
Funding source category [1] 310814 0
Self funded/Unfunded
Name [1] 310814 0
None
Country [1] 310814 0
Primary sponsor type
Individual
Name
GÜLSAH BARGI
Address
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country
Turkey
Secondary sponsor category [1] 312059 0
Individual
Name [1] 312059 0
ELIF SAHIN
Address [1] 312059 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country [1] 312059 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310381 0
Izmir Democracy University Non-Interventional Clinical Research of the Ethics Committee
Ethics committee address [1] 310381 0
Ethics committee country [1] 310381 0
Turkey
Date submitted for ethics approval [1] 310381 0
17/02/2022
Approval date [1] 310381 0
06/04/2022
Ethics approval number [1] 310381 0
2022/04-10

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117454 0
Dr GÜLSAH BARGI
Address 117454 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country 117454 0
Turkey
Phone 117454 0
+905317938766
Fax 117454 0
+90 232 260 1004
Email 117454 0
gulsah.bargi@idu.edu.tr
Contact person for public queries
Name 117455 0
GÜLSAH BARGI
Address 117455 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country 117455 0
Turkey
Phone 117455 0
+905317938766
Fax 117455 0
+90 232 260 1004
Email 117455 0
gulsah.bargi@idu.edu.tr
Contact person for scientific queries
Name 117456 0
GÜLSAH BARGI
Address 117456 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country 117456 0
Turkey
Phone 117456 0
+905317938764
Fax 117456 0
+90 232 260 1004
Email 117456 0
gulsah.bargi@idu.edu.tr

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
I can not share the data of individuals included in the study in our country within the scope of the personal data protection law.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.