Меню
Идёт набор NCT06594302

Functional Performance and Biopsychosocial Characteristics in Individuals with Systemic Sclerosis

— Наблюдательное Systemic Sclerosis (SSc)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Functional performance tests and scales measuring biopsychosocial characteristics.
Кому может быть актуально
Состояния в реестре: Systemic Sclerosis (SSc). Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

The Relationship Between Functional Performance and Biopsychosocial Characteristics in Individuals with Systemic Sclerosis

Обзор

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.

Вмешательства

  • Другое Functional performance tests and scales measuring biopsychosocial characteristics
    Functional performance tests and scales applications

Первичные конечные точки

  • BETY-Biopsychosocial Questionnaire [Срок оценки: Baseline]
  • Scleroderma Health Assessment Questionnaire (SHAQ) [Срок оценки: Baseline]
  • 6-Minute Walk Test-Borg Scale [Срок оценки: Baseline]
Вторичные конечные точки (12)
  • Modified Rodnan Skin Score (mRSS) [Срок оценки: Baseline]
  • Modified Hand Mobility in Scleroderma (mHAMIS) [Срок оценки: Baseline]
  • Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Baseline]
  • Duruoz Hand Index [Срок оценки: Baseline]
  • Short Form-36 (SF-36) [Срок оценки: Baseline]
  • Chronic Disease Self-Management Scale [Срок оценки: Baseline]
  • Exercise Self-Efficacy Scale [Срок оценки: Baseline]
  • Brief Illness Perception. Questionnaire [Срок оценки: Baseline]
  • Body Awareness Questionnaire [Срок оценки: Baseline]
  • Tampa Scale of Kinesiophobia (TSK) [Срок оценки: Baseline]
  • Central Sensitisation Inventory [Срок оценки: Baseline]
  • Five Times Sit to-Stand Test [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Being diagnosed with Systemic Sclerosis
  • To be between 18-65 years old
  • Being reader literate

Критерии исключения

  • Having a severe musculoskeletal disability
  • Being diagnosed with pulmonary hypertension
  • History of active infection
  • Having a severe neuropsychiatric disorder
  • Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Hacettepe University — Ankara

Идентификаторы

NCT: NCT06594302 · SBA 23/171

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗