Functional Performance and Biopsychosocial Characteristics in Individuals with Systemic Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Functional performance tests and scales measuring biopsychosocial characteristics.
- Who it may be relevant to
- Registry conditions: Systemic Sclerosis (SSc). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Relationship Between Functional Performance and Biopsychosocial Characteristics in Individuals with Systemic Sclerosis
Overview
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.
Interventions
- Other Functional performance tests and scales measuring biopsychosocial characteristics
Functional performance tests and scales applications
Primary outcome measures
- BETY-Biopsychosocial Questionnaire [Time frame: Baseline]
- Scleroderma Health Assessment Questionnaire (SHAQ) [Time frame: Baseline]
- 6-Minute Walk Test-Borg Scale [Time frame: Baseline]
Secondary outcome measures (12)
- Modified Rodnan Skin Score (mRSS) [Time frame: Baseline]
- Modified Hand Mobility in Scleroderma (mHAMIS) [Time frame: Baseline]
- Hospital Anxiety and Depression Scale (HADS) [Time frame: Baseline]
- Duruoz Hand Index [Time frame: Baseline]
- Short Form-36 (SF-36) [Time frame: Baseline]
- Chronic Disease Self-Management Scale [Time frame: Baseline]
- Exercise Self-Efficacy Scale [Time frame: Baseline]
- Brief Illness Perception. Questionnaire [Time frame: Baseline]
- Body Awareness Questionnaire [Time frame: Baseline]
- Tampa Scale of Kinesiophobia (TSK) [Time frame: Baseline]
- Central Sensitisation Inventory [Time frame: Baseline]
- Five Times Sit to-Stand Test [Time frame: Baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Hacettepe University — Ankara
Identifiers
NCT: NCT06594302 · SBA 23/171