Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001747819
Ethics application status
Approved
Date submitted
24/10/2021
Date registered
21/12/2021
Date last updated
30/11/2022
Date data sharing statement initially provided
21/12/2021
Date results provided
30/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Kinesiophobia, physical activity, depression, anxiety and stress levels in survivors with post-COVID-19.
Scientific title
Kinesiophobia, physical activity, depression, anxiety and stress levels in survivors with post-COVID-19.
Secondary ID [1] 305645 0
Nil known
Universal Trial Number (UTN)
U1111-1270-8249
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kinesiophobia 324069 0
Physical inactivity 324070 0
Depression 324071 0
Anxiety 324072 0
Stress 324073 0
COVID-19 324414 0
Condition category
Condition code
Infection 322142 322142 0 0
Other infectious diseases
Respiratory 322143 322143 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
In this study, it was planned to investigate the levels of kinesiophobia, physical activity, depression, anxiety and stress in individuals who have been exposed to COVID-19 compared to healthy individuals. Evaluation of kinesiophobia, physical activity, depression, anxiety and stress using an online form will be over in maximum a few hours.
Intervention code [1] 322035 0
Not applicable
Comparator / control treatment
In order to be able to compare with the individuals who have had COVID-19 in terms of levels of kinesiophobia, physical activity, depression, anxiety and stress, healthy individuals will be included in the control group.
Control group
Active

Outcomes
Primary outcome [1] 329351 0
Difference in kinesiophobia mean score which will be evaluated using Tampa Kinesiophobia Scale
Timepoint [1] 329351 0
at survey time, within a few hours after confirming enrolment
Secondary outcome [1] 402258 0
Difference in physical activity mean score which will be evaluated using International Physical Activity Questionnaire Short Form
Timepoint [1] 402258 0
at survey time, within a few hours after confirming enrolment
Secondary outcome [2] 402259 0
Difference in mean scores of depression levels which will be evaluated using Depression Anxiety Stress-21 Scale
Timepoint [2] 402259 0
at survey time, within a few hours after confirming enrolment
Secondary outcome [3] 403306 0
Difference in mean scores of anxiety levels which will be evaluated using Depression Anxiety Stress-21 Scale
Timepoint [3] 403306 0
at survey time, within a few hours after confirming enrolment
Secondary outcome [4] 403307 0
Difference in mean scores of stress levels which will be evaluated using Depression Anxiety Stress-21 Scale
Timepoint [4] 403307 0
at survey time, within a few hours after confirming enrolment

Eligibility
Key inclusion criteria
Inclusion criteria for the individuals who have had COVID-19 were:
*adult individuals aged 18 and over
*volunteering to participate in the study,
*Individuals who can understand and answer questionnaires
*Individuals who have technological devices such as smart phones, computers, ipads, laptops where questionnaires can be administered.
*Individuals who were diagnosed with COVID-19 (individuals with a positive Polymerase Chain Reaction (PCR) test result, compatible with COVID-19 infection as a result of lung X-ray or lung tomography despite negative PCR test results) and discharged after recovery/home quarantine completed

Inclusion criteria for the healthy individuals were:
*adult individuals aged 18 and over
*volunteering to participate in the study,
*Individuals who can understand and answer questionnaires
*Individuals who have technological devices such as smart phones, computers, ipads, laptops where questionnaires can be administered.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for the individuals who have had COVID-19 were:
* Individuals with any physical or mental disability/disease and/or cognitive impairment
• Individuals newly diagnosed with COVID-19, therefore in quarantine at home or receiving treatment in hospital
• Individuals with suspected COVID-19
• Pregnant women
• Those who have any chronic disease that prevents them from doing physical activity

Exclusion criteria for the healthy individuals were:
*Individuals with any physical or mental disability
*Individuals with any acute or chronic infection and/or health problems
*Individuals who are in quarantine for any reason

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
Actual
25/11/2021
Date of last participant enrolment
Anticipated
28/02/2022
Actual
31/12/2021
Date of last data collection
Anticipated
28/02/2022
Actual
1/01/2022
Sample size
Target
28
Accrual to date
Final
49
Recruitment outside Australia
Country [1] 24247 0
Turkey
State/province [1] 24247 0
Izmir

Funding & Sponsors
Funding source category [1] 310003 0
Self funded/Unfunded
Name [1] 310003 0
None
Country [1] 310003 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] 311056 0
None
Name [1] 311056 0
Address [1] 311056 0
Country [1] 311056 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309713 0
Izmir Democracy University Non-Interventional Clinical Research of the Ethics Committee
Ethics committee address [1] 309713 0
Ethics committee country [1] 309713 0
Turkey
Date submitted for ethics approval [1] 309713 0
01/09/2021
Approval date [1] 309713 0
03/11/2021
Ethics approval number [1] 309713 0
2021/14-02

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

Contacts
Principal investigator
Name 115134 0
Dr GÜLSAH BARGI
Address 115134 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 115134 0
Turkey
Phone 115134 0
+90 232 260 1001
Fax 115134 0
+90 232 260 1004
Email 115134 0
[email protected]
Contact person for public queries
Name 115135 0
GÜLSAH BARGI
Address 115135 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 115135 0
Turkey
Phone 115135 0
+90 232 260 1001
Fax 115135 0
+90 232 260 1004
Email 115135 0
[email protected]
Contact person for scientific queries
Name 115136 0
GÜLSAH BARGI
Address 115136 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 115136 0
Turkey
Phone 115136 0
+90 232 260 1001
Fax 115136 0
+90 232 260 1004
Email 115136 0
[email protected]

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.