Investigating the Effectiveness of the Biopsychosocial Model-Based Exercise Approach in Children and Adults Diagnosed With Scleroderma
NCT ID: NCT07292961
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2025-12-04
2027-12-04
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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BETY session group
Children and adults with scleroderma are participating in BETY sessions two times a week for 3 months.
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.
Control Group
Children and adults with scleroderma are followed up with a home exercise program.
Control group
The control group will be followed up with a home exercise program, and notes will be taken.
Interventions
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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.
Control group
The control group will be followed up with a home exercise program, and notes will be taken.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cases aged 7-18 years will be included.
* Individuals diagnosed with scleroderma,
* Individuals over the age of 18 will be included.
Exclusion Criteria
* 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\*
* 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
7 Years
ALL
No
Sponsors
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Hacettepe University
OTHER
Responsible Party
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Orkun Tüfekçi
Principal Investigator, PT, PhD(c)
Locations
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Hacettepe University
Ankara, Altındağ, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Orkun Tüfekçi, PT, PhD(c)
Role: primary
Other Identifiers
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FTREK25/154
Identifier Type: -
Identifier Source: org_study_id