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

NCT07292961 | Recruiting

• 1 other identifier: FTREK25/154
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Keywords

biopsychosocial model; exercise; scleroderma; juvenile scleroderma

Outcome Measures

Primary Outcomes (5)

• Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Patient

  It is a patient/parent-centered measurement method that helps assess the patient's biopsychosocial aspects, such as disease activity, posture, functional and psychosocial status, fatigue, and school performance. The results from the questions are used to assess the functional status of children, while their psychosocial status is recorded based on their answers to 21 questions (ranging from 0 to 358). A high score indicates a poor psychosocial status.

  Six months

• Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)

  It was standardized as a biopsychosocial assessment tool and is scored using a 5-point Likert scale, with each item rated from 0 to 4 points. A high total score on the 30-item scale indicates a high level of biopsychosocial impact.

  Six months

• Modified Rodnan skin score (MRSS)

  A pediatric and adult rheumatologist assessed it. The MRSS evaluates skin thickening in 17 body regions, graded from 0 (normal) to 3 (severe skin thickening). The total score ranges from 0 to 51, with increased scores indicating poor skin involvement.

  Six months

• Localized Scleroderma Assessment Tool (LoSCAT)

  LoSCAT consists of two sections: the modified Localized Skin Severity Index, which measures disease activity, and the Localized Scleroderma Damage Index, which assesses damage (usually scored between 0 and 3). The Localized Skin Severity Index evaluates the color of the lesion border for erythema, skin thickness, and the presence of new lesions or lesion extension. In the Localized Scleroderma Damage Index, three areas of cutaneous damage are combined to obtain a score. These areas evaluate hyperpigmentation or hypopigmentation, whichever is more prominent, as well as dermal atrophy, subcutaneous atrophy, and dyspigmentation.

  Six months

• 6-Minute Walk Test

  Participants are asked to walk as quickly as they can along a 30-meter corridor. The total distance will be measured in meters. Fatigue, pain, and dyspnea will be monitored using the Modified Borg Scale.

  Six months

Secondary Outcomes (20)

• Childhood Health Assessment Questionnaire (CHAQ)

  Six months

• Juvenile Arthritis Quality of Life Questionnaire (JAQQ)

  Six months

• Child and Adolescent Scale of Participation (CASP)

  Six months

• Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Family

  Six months

• Pediatric Eating Assessment Scale (PEDI-EAT-10)

  Six months

Study Arms (2)

BETY session group

EXPERIMENTAL

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

Other: Cognitive Exercise Therapy Approach

Control Group

ACTIVE COMPARATOR

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

Other: Control group

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.

Also known as: Bilişsel Egzersiz Terapi Yaklaşımı (BETY)

BETY session group

Control group OTHER

The control group will be followed up with a home exercise program, and notes will be taken.

Control Group

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cases diagnosed with scleroderma,
• Cases aged 7-18 years will be included.

You may not qualify if:

• 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\*
• Individuals diagnosed with scleroderma,
• Individuals over the age of 18 will be included.
• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Localized; Scleroderma, Systemic; Juvenile systemic scleroderma; Motor Activity; Juvenile-onset scleroderma

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Orkun Tüfekçi, PT, PhD (c)

CONTACT

+903123052525; orkuntf@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PT, PhD(c)

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 18, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): December 4, 2027
• Study Completion (Estimated): December 4, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

TU (1)