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

Hacettepe University

Status: Enrolling

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

Treatments: Other: Control group; Other: Cognitive Exercise Therapy Approach

Study type: Interventional

Funder types: Other

Identifiers

NCT07292961

FTREK25/154

Details and patient eligibility

About

This study aims to investigate the effectiveness of BETY, an exercise approach based on the biopsychosocial model, in children and adults diagnosed with scleroderma.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

BETY session group

Experimental group

Description:

Children and adults with scleroderma are participating in BETY sessions two times a week for 3 months.

Treatment:

Other: Cognitive Exercise Therapy Approach

Control Group

Active Comparator group

Description:

Children and adults with scleroderma are followed up with a home exercise program.

Treatment:

Other: Control group