Investigating the Effectiveness of the Biopsychosocial Model-Based Exercise Approach in Children and Adults Diagnosed With Scleroderma
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: Cognitive Exercise Therapy Approach, Control group.
- Кому может быть актуально
- Состояния в реестре: Scleroderma, Scleroderma, Localized, Scleroderma Systemic, Scleroderma (Limited and Diffuse). Базовые параметры: от 7 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 →
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Официальное название
Investigating the Effectiveness of the Biopsychosocial Model-Based Exercise Approach (BETY) in Children and Adults Diagnosed With Scleroderma: A Single-Blind Randomized Controlled Trial
Обзор
This study aims to investigate the effectiveness of BETY, an exercise approach based on the biopsychosocial model, in children and adults diagnosed with scleroderma.
Подробное описание
EULAR recommendations on non-pharmacological treatment of scleroderma emphasize physical activity and patient education, disease-specific, evidence-based management strategies tailored to the individual, and self-management. Physical exercise is the most widely studied disease management strategy in scleroderma.
There is a reported need for biopsychosocial treatment approaches in disease management for cases and individuals diagnosed with scleroderma; therefore, the use of biopsychosocial approaches in the field of exercise is also recommended.
The Cognitive Exercise Therapy Approach (BETY), an innovative exercise approach developed for adults diagnosed with rheumatic diseases, also aims to promote behavioral change through exercises that provide pain management and functional gains in pediatric rheumatology, and to prevent social isolation through group support. As in adults, there is a need for exercise approaches, such as BETY, that align with the biopsychosocial model in pediatric cases.
BETY, previously implemented via telerehabilitation in individuals diagnosed with systemic sclerosis, has been shown to have beneficial effects on functionality, muscle strength, vascular structures, inflammatory markers, and biopsychosocial status.
In this context, there is a clear need for interventions that support both children and adults diagnosed with scleroderma physically and psychosocially. This study aims to investigate the effectiveness of BETY, an exercise approach based on the biopsychosocial model, in children and adults diagnosed with scleroderma.
Вмешательства
- Другое Cognitive Exercise Therapy Approach
The biopsychosocial model-based exercise approach (BETY) will be applied for 24 one-hour sessions, two days a week, for 3 months. - Другое Control group
The control group will be followed up with a home exercise program, and notes will be taken.
Первичные конечные точки
- Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Patient [Срок оценки: Six months]
- Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ) [Срок оценки: Six months]
- Modified Rodnan skin score (MRSS) [Срок оценки: Six months]
- Localized Scleroderma Assessment Tool (LoSCAT) [Срок оценки: Six months]
- 6-Minute Walk Test [Срок оценки: Six months]
Вторичные конечные точки (12)
- Childhood Health Assessment Questionnaire (CHAQ) [Срок оценки: Six months]
- Juvenile Arthritis Quality of Life Questionnaire (JAQQ) [Срок оценки: Six months]
- Child and Adolescent Scale of Participation (CASP) [Срок оценки: Six months]
- Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Family [Срок оценки: Six months]
- Pediatric Eating Assessment Scale (PEDI-EAT-10) [Срок оценки: Six months]
- Pain Catastrophizing Scale-Parent (PCS-P) [Срок оценки: Six months]
- Scleroderma Health Assessment Questionnaire (SHAQ) [Срок оценки: Six months]
- Short Form-36 (SF-36) [Срок оценки: Six months]
- Turkish Eating Assessment Tool (T-EAT-10) [Срок оценки: Six months]
- Isokinetic Muscle Measurement [Срок оценки: Six months]
- Standard grip strength [Срок оценки: Six months]
- Upper Extremity Proprioception Assessment [Срок оценки: Six months]
Критерии участия
\*For a child diagnosed with scleroderma\*
Критерии включения
- Cases diagnosed with scleroderma,
- Cases aged 7-18 years will be included.
Критерии исключения
- Advanced heart/lung/liver/kidney disease, neurological disease, and malignancies
- Cases that are not willing to participate in the study will be excluded.
- History of developmental delay
- Having participated in a regular exercise program for the past 3 months
- Individuals who are not willing to participate in the study
\*For adults diagnosed with scleroderma\*
Критерии включения
- Individuals diagnosed with scleroderma,
- Individuals over the age of 18 will be included.
Критерии исключения
- Advanced heart/lung/liver/kidney disease, neurological disease, and malignancies
- Individuals who are not willing to participate in the study will be excluded.
- Having participated in a regular exercise program for the past 3 months
- Individuals who are not willing to participate in the study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Turkey (Türkiye) · 1 центр
- Hacettepe University — Ankara
Идентификаторы
NCT: NCT07292961 · FTREK25/154