Clinical trial Recruiting at 1 site Interventional Ages 7 and up

Biopsychosocial (BETY) exercise program for children and adults with scleroderma

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

Run by Hacettepe University · NCT07292961 · Data updated 2026-11-12

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

Study typeInterventional
Ages7 Years and up
SexAll
Enrollment48 (estimated)
SponsorHacettepe University
Academic / other
Locations1 site (Ankara, Altındağ)
StatusRecruiting
StartedDecember 4, 2025
Main results expectedDecember 4, 2027
Study endsDecember 4, 2027
Registry record updatedDecember 18, 2025
Trial IDNCT07292961 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Hacettepe University
    Ankara, Altındağ, Turkey (Türkiye)
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.