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

Sponsor
Hacettepe University
Study ID
NCT07292961
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
7 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Exercise Therapy Approach — OTHER
    The biopsychosocial model-based exercise approach (BETY) will be applied for 24 one-hour sessions, two days a week, for 3 months.
  • Control group — OTHER
    The control group will be followed up with a home exercise program, and notes will be taken.

Study Details

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

Key Dates

Start date
Dec 4, 2025
Status verified
Dec 2025
Primary completion
Dec 4, 2027
Completion
Dec 4, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BETY session group
    Children and adults with scleroderma are participating in BETY sessions two times a week for 3 months.
  • Active Comparator: Control Group
    Children and adults with scleroderma are followed up with a home exercise program.

Primary Outcome Measure

Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Patient [ Time Frame: Six months ]

Central Contacts

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