NCT06594302 Functional Performance and Biopsychosocial Characteristics in Individuals with Systemic Sclerosis
| NCT ID | NCT06594302 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hacettepe University |
| Condition | Systemic Sclerosis (SSc) |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-10-04 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-10-04 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In individuals with systemic sclerosis (SSc), the loss of functionality severely affects quality of life. This condition may cause psychosocial effects by affecting the person, their family, and the environment. Activities of daily living, quality of life, and psychosocial well-being are affected, and aesthetic concerns arise. Different scales evaluating the quality of life, functions, and disease characteristics of individuals diagnosed with SSc are accepted. In this field, modified Rodnan skin score (mRDS), Duruöz hand index (DHI), scleroderma health assessment questionnaire (SHAQ), and Short Form-36 (SF-36) are frequently used. The BETY-Biopsychosocial Questionnaire is also included in the literature for the evaluation of the biopsychosocial effects of individuals with rheumatism. In addition, it is essential to evaluate the characteristics of individuals who maintain their health with chronic diseases. Therefore, assessment parameters such as the Chronic Disease Self-Management Scale, Exercise Self-Efficacy Scale, Short Form Illness Perception Scale, Body Awareness Questionnaire, Central Sensitisation Scale, and Tampa Kinesiophobia Questionnaire are frequently used in this regard. The 6 Minute Walk Test (6 MWT) is recommended as a frequently used method to determine cardiopulmonary endurance in individuals with SSc. It is known that there is a decrease in the distance walked in this test compared to healthy individuals, and the fall potential of physical performance is an important parameter. In addition, there are also methods used to evaluate physical performance, such as the five-repetition sit-and-stand test (CST), the Stair Climbing Test (SCT), and the Timed up-and-go test (TUG). Considering all these effects, there is a need to examine the relationship between functional and biopsychosocial impact in individuals with SSc. This study aims to examine the relationship between functional performance and biopsychosocial characteristics in individuals diagnosed with systemic sclerosis and to present the results for this disease group.
Eligibility Criteria
Inclusion Criteria: * Being diagnosed with Systemic Sclerosis * To be between 18-65 years old * Being reader literate Exclusion Criteria: * Having a severe musculoskeletal disability * Being diagnosed with pulmonary hypertension * History of active infection * Having a severe neuropsychiatric disorder * Pregnancy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06594302 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Systemic Sclerosis (SSc). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06594302 currently recruiting?
Yes, NCT06594302 is actively recruiting participants. Contact the research team at orkuntf@gmail.com for enrollment information.
Where is the NCT06594302 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT06594302 clinical trial?
NCT06594302 is sponsored by Hacettepe University. The trial plans to enroll 50 participants.