NCT06383286

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

April 22, 2024

Last Update Submit

April 22, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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

    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.

    8 months

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

disabled athletes who prepared the Paralympic Games

You may qualify if:

  • Being a physically disabled athlete
  • Preparation for the Paralympic Games
  • Volunteering to participate in the study

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt Univercity

Ankara, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
8 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

April 22, 2024

First Posted

April 25, 2024

Study Start

December 1, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2022

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations