Investigating the Effectiveness of the Biopsychosocial Model-Based Exercise Approach in Children and Adults Diagnosed 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 study aims to investigate the effectiveness of BETY, an exercise approach based on the biopsychosocial model, in children and adults diagnosed with scleroderma.

Study Overview

• Status: Recruiting
• Conditions: Scleroderma, Localized; Scleroderma; Systemic Sclerosis (SSc); Scleroderma Systemic; Scleroderma (Limited and Diffuse); Juvenile Systemic Sclerosis; Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria
• Intervention / Treatment: Other: Cognitive Exercise Therapy Approach; Other: Control group

Detailed Description

EULAR recommendations on non-pharmacological treatment of scleroderma emphasize physical activity and patient education, disease-specific, evidence-based management strategies tailored to the individual, and self-management. Physical exercise is the most widely studied disease management strategy in scleroderma.

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Orkun Tüfekçi, PT, PhD (c); Phone Number: +903123052525; Email: orkuntf@gmail.com

Study Locations

• Turkey (Türkiye)
  • Altındağ
    • Ankara, Altındağ, Turkey (Türkiye), 06100
      • Recruiting
      • Hacettepe University
      • Contact: Orkun Tüfekçi, PT, PhD(c); Phone Number: +903123052525; Email: orkuntf@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

*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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BETY session group; Children and adults with scleroderma are participating in BETY sessions two times a week for 3 months.	Other: 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.; Other Names: Bilişsel Egzersiz Terapi Yaklaşımı (BETY)
Active Comparator: Control Group; Children and adults with scleroderma are followed up with a home exercise program.	Other: Control group; The control group will be followed up with a home exercise program, and notes will be taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Childhood Health Assessment Questionnaire (CHAQ)	It assesses the functional abilities of children diagnosed with rheumatic diseases in their daily living activities. It consists of eight subscales (dressing and personal care, standing up, eating, walking, body care, reaching, grasping, activities) (0-3) and also assesses pain and general well-being using a visual analog scale (0-100). A high score indicates low functionality.	Six months
Juvenile Arthritis Quality of Life Questionnaire (JAQQ)	It consists of 74 items covering various health domains, including physical functioning, emotional well-being, and general symptoms. The items are divided into four dimensions related to the child's quality of life: gross motor function (GMF), fine motor function (FMF), psychosocial function (PF), and systemic or general symptoms (SGS). Each domain is scored on a Likert-type scale from 1 to 7, with higher scores indicating poorer health-related quality of life. There is also a "not applicable to me" option for the items. The scale also includes a pain measurement (10 cm Visual Analog Scale (VAS)) to assess pain, but this score is not included in the total score.	Six months
Child and Adolescent Scale of Participation (CASP)	It is a 20-question survey that assesses children's and adolescents' community participation in school, neighborhood, and local settings. The survey is divided into four sections: 6 questions about home participation, four questions about neighborhood and community involvement, five questions about school participation, and five questions about home and community engagement. It is rated on a scale of "expected for their age (full participation), somewhat limited, very limited, unable to participate, and inapplicable." The survey is completed by the child's family or primary caregiver. The person filling out the questionnaire is asked to select the answer that best describes the child's level of participation. The assessment is scored out of 100 points, with higher scores indicating greater participation.	Six months
Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Family	JAB-Q is a multidimensional questionnaire and a parent (family) form. Developed in Turkish by Ünal and colleagues, the questionnaire is completed by one of the child's parents. The family form evaluates the parents' biopsychosocial status from their own perspective and provides scores ranging from 0 to 102. Higher scores indicate a worse biopsychosocial status.	Six months
Pediatric Eating Assessment Scale (PEDI-EAT-10)	It is used to evaluate swallowing disorders in pediatric patients. It was developed as the pediatric version of the EAT-10, which is used in adults. The PEDI-EAT-10 comprises 10 questions, each with a Likert scale ranging from 0 to 4 (0 = no problem, 4 = severe problem). The total score is calculated out of 40 points.	Six months
Pain Catastrophizing Scale-Parent (PCS-P)	It is assessed using a 5-point Likert scale ranging from 0 (never) to 4 (always) and consists of 13 items. Similar to the child questionnaire, it assesses 3 domains: rumination, magnification, and helplessness. A total score between 0 and 52 is obtained; higher scores reflect a higher level of catastrophizing in parents.	Six months
Scleroderma Health Assessment Questionnaire (SHAQ)	It was developed by adding five questions to the HAQ regarding Raynaud's phenomenon, digital ulcers, gastrointestinal, pulmonary, and general scleroderma symptoms, to be rated on a 15 cm line. The SHAQ total score ranges from 0 to 3. A high score indicates low functionality.	Six months
Short Form-36 (SF-36)	It will be used to determine an individual's quality-of-life level. Each sub-parameter is scored between 0 and 100, with higher scores indicating better health status. The SF-36 scale has eight sub-parameters: general health perception, physical function, social function, pain, mental health, role difficulty due to physical reasons, role difficulty due to emotional reasons, and vitality. It contains 11 questions, each with 36 items.	Six months
Turkish Eating Assessment Tool (T-EAT-10)	It is a questionnaire consisting of 10 questions with a Likert scale ranging from 0 to 4 (0 = no problem, 4 = severe problem). The total score is calculated out of 40 points by summing the responses given to each question. A score of 3 or higher is considered abnormal in the questionnaire.	Six months
Isokinetic Muscle Measurement	Individuals' knee muscle strength will be assessed using the Biodex System 3 Pro® isokinetic device (Biodex Medical Systems Inc., Shirley, NY, USA), which is routinely used at Hacettepe University, Faculty of Medicine, Department of Sports Medicine. Before each assessment, participants will perform a 10-minute warm-up walk and then undergo maximal concentric isokinetic muscle strength tests of the knee flexors and extensors at angular velocities of 180°/s (10 repetitions) and 60°/s (5 repetitions), with 30-second rest intervals. Peak torque (PT) and average power (AP) will be recorded in newton-meters (Nm) and watts (W), respectively. Participants will be informed in advance of how to perform maximum-power training, and verbal encouragement will be provided during the tests.	Six months
Standard grip strength	Hand grip strength will be evaluated using the Jamar hand dynamometer (Jamar; JLW Instruments, Chicago, IL), which is routinely used at Hacettepe University, Faculty of Medicine, Department of Sports Medicine. The test will be administered according to the American Hand Therapy Association's assessment recommendations. According to these recommendations, measurements will be taken with individuals seated in a chair without armrests, with the arm in adduction, the elbow at 90° flexion, the forearm in mid-rotation, and the wrist in a neutral position. A 15-second rest interval will be given between each measurement, and a total of three measurements will be taken. The average of the three scores will be recorded in kilograms-force.	Six months
Upper Extremity Proprioception Assessment	Proprioception assessment will be performed at the wrist based on the principle of actively repeating a predetermined target angle. Measurements will be applied in all axes of movement of the wrist (flexion-extension, radial-ulnar deviation) on a surface showing a 180-degree angle range. Target angles are set at 30° for flexion-extension, 10° for radial deviation, and 15° for ulnar deviation.	Six months
Vascular Structures	Vascular assessments will be performed using Doppler ultrasound in the Department of Radiology at Hacettepe University Faculty of Medicine. Spectral Doppler ultrasonography and shear wave elastography (SWE) measurements will be performed using a 9 MHz linear probe on a Siemens Acuson S2000 device. Doppler US measurements will be taken from the radial and posterior tibial arteries, and the Resistive Index (RI = peak systolic velocity - end-diastolic velocity/peak systolic velocity) value will be calculated. Three measurements will be taken from each artery, and the average RI value will be used. SWE measurements will be performed on the bilateral deltoid, rectus femoris, and forearm extensor muscles. Three measurements will be taken from the medial and lateral regions of each muscle, and the average SWE value will be obtained. Before all measurements, participants will rest for at least 30 minutes, and the probe will be placed parallel to the muscle fibers.	Six months
Inflammatory Markers	Inflammatory markers will be collected via venipuncture during routine testing on the day of the clinical interview. Collected blood samples will be centrifuged at 2000 × g for 10 minutes and stored at -80 °C until kit analysis. Serum cytokine levels (TNF-α, IL-1, IL-6, IL-10) and serum irisin levels will be determined using ELISA kits.	Six months
Modified Hand Mobility in Scleroderma Test (mHAMIS)	It is a functional test developed specifically for scleroderma to assess an individual's hand function. It evaluates four specific hand movements (finger flexion, finger extension, finger abduction, and dorsal extension). Scores range from 0 (normal) to 3 (complete failure) for each movement, with a total score ranging from 0 to 12.	Six months
Maximum mouth opening (MAO)	After ensuring individuals open their mouths as widely as possible, the distance between the incisal edges of the central incisors in the upper and lower jaws is measured in millimeters and recorded.	Six months
Timed Up and Go Test	The time it takes a person to rise from a chair with back support, walk 3 meters at a normal pace, and return to the chair is measured in seconds to evaluate lower-extremity balance. The test will be performed 3 times.	Six months
10-Step Stair Climbing Test	To assess the subject's lower extremity strength and dynamic balance, the time taken to quickly climb and descend a staircase with 10 steps, each measuring 16-20 cm high and equipped with a handrail, is recorded in seconds. The test is repeated three times, and the times are recorded.	Six months
10-meter walk test	The individual is on a 10-meter path. The assessment is performed in three repetitions and recorded in seconds.	Six months
30-second sit-to-stand test	It is performed to evaluate lower-extremity endurance by having the individual stand up from a chair with their arms crossed over their chest, then sit back down. The individual is instructed to repeat this as quickly as possible for 30 seconds. The score for this assessment is the number of times the person fully rises from a seated position with arms crossed within 30 seconds.	Six months

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2025
• Primary Completion (Estimated): December 4, 2027
• Study Completion (Estimated): December 4, 2027

Study Registration Dates

• First Submitted: December 6, 2025
• First Submitted That Met QC Criteria: December 6, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 6, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: exercise; scleroderma; biopsychosocial model; juvenile scleroderma
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Skin Diseases; Behavior; Skin and Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized; Motor Activity; Juvenile-onset scleroderma; Juvenile systemic scleroderma; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: FTREK25/154

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No