Biopsychosocial (BETY) exercise program for children and adults 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
This project will test whether BETY, a biopsychosocial exercise program, helps children and adults with scleroderma improve physical function and psychosocial well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 7 Years and up |
| Sex | All |
| Sponsor | Hacettepe University Academic / other |
| Locations | 1 site (Ankara, Altındağ) |
| Trial ID | NCT07292961 on ClinicalTrials.gov |
What this trial studies
This interventional trial will deliver the Cognitive Exercise Therapy Approach (BETY), a biopsychosocial exercise program, to children (7–18) and adults with scleroderma and compare outcomes with a control group. BETY combines physical exercises, cognitive-behavioral techniques, and group support to promote pain management, functional gains, and behavioral change. Key exclusions include advanced heart, lung, liver, or kidney disease, neurological disease, malignancy, developmental delay, and recent participation in a regular exercise program; outcomes will include measures of function, muscle strength, vascular and inflammatory markers, and psychosocial status. The intervention has been used previously via telerehabilitation in systemic sclerosis and is being tested at Hacettepe University to see if similar benefits extend across pediatric and adult scleroderma patients.
Who should consider this trial
Good fit: Ideal participants are children aged 7–18 and adults over 18 with a diagnosis of scleroderma who do not have advanced organ failure, neurological disease, malignancy, developmental delay, and who have not been in a regular exercise program in the prior three months and are willing to participate.
Not a fit: Patients with advanced heart, lung, liver, or kidney disease, active neurological disease or malignancy, developmental delay, or those already in regular exercise programs are less likely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, BETY could improve physical function, reduce symptoms, and enhance psychosocial well-being for people with scleroderma.
How similar studies have performed: Exercise programs have shown benefits in scleroderma and BETY delivered via telerehabilitation in systemic sclerosis produced improvements in function, strength, vascular markers, inflammatory markers, and biopsychosocial outcomes, but applying BETY broadly to pediatric and mixed scleroderma populations is relatively novel.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Ankara, Altındağ
- Hacettepe University — Ankara, Altındağ, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Orkun Tüfekçi, PT, PhD (c)
- Email: orkuntf@gmail.com
- Phone: +903123052525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.