Investigating the Effectiveness of the Biopsychosocial Model-Based Exercise Approach in Children and Adults Diagnosed With Scleroderma
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: Cognitive Exercise Therapy Approach, Control group.
- Who it may be relevant to
- Registry conditions: Scleroderma, Scleroderma, Localized, Scleroderma Systemic, Scleroderma (Limited and Diffuse). Basic parameters: from 7 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 →
Unsure about the terms? Read our patient guide →
Official title
Investigating the Effectiveness of the Biopsychosocial Model-Based Exercise Approach (BETY) in Children and Adults Diagnosed With Scleroderma: A Single-Blind Randomized Controlled Trial
Overview
This study aims to investigate the effectiveness of BETY, an exercise approach based on the biopsychosocial model, in children and adults diagnosed with scleroderma.
Detailed description
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.
Interventions
- Other 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. - Other Control group
The control group will be followed up with a home exercise program, and notes will be taken.
Primary outcome measures
- Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Patient [Time frame: Six months]
- Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ) [Time frame: Six months]
- Modified Rodnan skin score (MRSS) [Time frame: Six months]
- Localized Scleroderma Assessment Tool (LoSCAT) [Time frame: Six months]
- 6-Minute Walk Test [Time frame: Six months]
Secondary outcome measures (12)
- Childhood Health Assessment Questionnaire (CHAQ) [Time frame: Six months]
- Juvenile Arthritis Quality of Life Questionnaire (JAQQ) [Time frame: Six months]
- Child and Adolescent Scale of Participation (CASP) [Time frame: Six months]
- Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Family [Time frame: Six months]
- Pediatric Eating Assessment Scale (PEDI-EAT-10) [Time frame: Six months]
- Pain Catastrophizing Scale-Parent (PCS-P) [Time frame: Six months]
- Scleroderma Health Assessment Questionnaire (SHAQ) [Time frame: Six months]
- Short Form-36 (SF-36) [Time frame: Six months]
- Turkish Eating Assessment Tool (T-EAT-10) [Time frame: Six months]
- Isokinetic Muscle Measurement [Time frame: Six months]
- Standard grip strength [Time frame: Six months]
- Upper Extremity Proprioception Assessment [Time frame: Six months]
Eligibility criteria
\*For a child diagnosed with scleroderma\*
Inclusion criteria
- Cases diagnosed with scleroderma,
- Cases aged 7-18 years will be included.
Exclusion criteria
- 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\*
Inclusion criteria
- Individuals diagnosed with scleroderma,
- Individuals over the age of 18 will be included.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Hacettepe University — Ankara
Identifiers
NCT: NCT07292961 · FTREK25/154