Paralympic AthletesNCT06383286
The Relationship Between Physical Activity Levels and Anxiety, Depression, Stress of Disabled Athletes
An observational study of Paralympic Athletes, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to investigate the relationship between anxiety, depression, stress and physical activities of disabled athletes prepared for the paralympic games to be held in Tokyo in 2021, 3 times in total at 2-3 months intervals, and to determine the change over time Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Paralympic Athletes
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 1 Mar 2022
- How long will I take part?
- 8 Months
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: disabled athletes who prepared the Paralympic Games
Who may be able to join
- Being a physically disabled athlete
- Preparation for the Paralympic Games
- Volunteering to participate in the study
Who cannot join
- Serious psychiatric illness
- Regular use of sedatives or neuropsychiatric drugs
- presence of active alcohol or drug addiction
- Presence of a systemic or neurological problem that develops independent of disability pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Physical Activity Levels and Anxiety, Depression, Stress of Disabled Athletes Who Prepared for Paralympic Games
It is aimed to investigate the relationship between anxiety, depression, stress and physical activities of disabled athletes prepared for the paralympic games to be held in Tokyo in 2021, 3 times in total at 2-3 months intervals, and to determine the change over time
- Conditions
- Paralympic Athletes
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory (STAI)
This inventory consists of two subscales(state and trait), each consisting of 20 questions. The state anxiety scale determines how the individual feels at a particular moment and under certain conditions, while the trait anxiety scale determines how the individual feels independent of the situation and conditions he or she is in.
Measured: 8 months
The Center for Epidemiological Studies Depression Scale (CES-D)
The CES-Depression Scale is a short self-report scale developed by the American National Institute of Mental Health to be used in scientific studies to evaluate the depressive symptoms of the general population. The scale has 20 items and asks questions about feelings and thoughts about the past week.
Measured: 8 months
Fatigue Severity Scale
It is used to determine the fatigue status of the participants. The scale consists of 9 items and evaluates the last week.
Measured: 8 months
International Physical Activity Questionnaire short form
The questionnaire, consisting of seven questions, provides information about sitting, walking, moderately activities, and time spent on vigorous activities. The total score is calculated by adding walking, moderate-intensive, vigorous activity, and the duration (minutes) and frequency (days) of these activities
Measured: 8 months
Perceived Stress Scale (PSS-14)
Consisting of 14 items, the PSS is designed to measure how stressful certain situations in a person's life are perceived.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Dec 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paralympic AthletesStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- Other
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar Anaforoglu, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383286
- Sponsor's protocol ID
- AnkaraYBUfby
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Physical Activity Levels and Anxiety, Depression, Stress of Disabled Athletes Who Prepared for Paralympic Games
- ClinicalTrials.gov ID
- NCT06383286
- Acronym / sponsor ID
- AnkaraYBUfby
- Conditions
- Paralympic Athletes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 25 Apr 2024 (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.
It is aimed to investigate the relationship between anxiety, depression, stress and physical activities of disabled athletes prepared for the paralympic games to be held in Tokyo in 2021, 3 times in total at 2-3 months intervals, and to determine the change over time
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 8 Months
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- disabled athletes who prepared the Paralympic Games
Key inclusion criteria (3 listed)
- Being a physically disabled athlete
- Preparation for the Paralympic Games
- Volunteering to participate in the study
Key exclusion criteria (4 listed)
- Serious psychiatric illness
- Regular use of sedatives or neuropsychiatric drugs
- presence of active alcohol or drug addiction
- Presence of a systemic or neurological problem that develops independent of disability pathology.
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
State-Trait Anxiety Inventory (STAI)
Time frame: 8 months
This inventory consists of two subscales(state and trait), each consisting of 20 questions. The state anxiety scale determines how the individual feels at a particular moment and under certain conditions, while the trait anxiety scale determines how the individual feels independent of the situation and conditions he or she is in.
The Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: 8 months
The CES-Depression Scale is a short self-report scale developed by the American National Institute of Mental Health to be used in scientific studies to evaluate the depressive symptoms of the general population. The scale has 20 items and asks questions about feelings and thoughts about the past week.
Fatigue Severity Scale
Time frame: 8 months
It is used to determine the fatigue status of the participants. The scale consists of 9 items and evaluates the last week.
International Physical Activity Questionnaire short form
Time frame: 8 months
The questionnaire, consisting of seven questions, provides information about sitting, walking, moderately activities, and time spent on vigorous activities. The total score is calculated by adding walking, moderate-intensive, vigorous activity, and the duration (minutes) and frequency (days) of these activities
Perceived Stress Scale (PSS-14)
Time frame: 8 months
Consisting of 14 items, the PSS is designed to measure how stressful certain situations in a person's life are perceived.
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 2024.
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 Paralympic Athletes, run by Ankara Yildirim Beyazıt 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 3 inclusion and 4 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 2024. 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?
State-Trait Anxiety Inventory (STAI) (time frame: 8 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2024.