NCT07292961

Investigating the Effectiveness of the Biopsychosocial Model-Based Exercise Approach in Children and Adults Diagnosed With Scleroderma

Investigating the Effectiveness of the Biopsychosocial Model-Based Exercise Approach (BETY) in Children and Adults Diagnosed With Scleroderma: A Single-Blind Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Scleroderma
• Scleroderma, Localized
• Scleroderma Systemic
• Scleroderma (Limited and Diffuse)
• Systemic Sclerosis (SSc)
• Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria
• Juvenile Systemic Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-04
• Primary completion: 2027-12-04
• Completion: 2027-12-04
• First posted: 2025-12-18
• Last updated: 2025-12-18

Locations

1 site across 1 country: Turkey (Türkiye)