Investigating the Effectiveness of the Biopsychosocial Model-Based Exercise Approach (BETY) in Children and Adults Diagnosed With Scleroderma: A Single-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Patient
研究概览
简要总结
This study aims to investigate the effectiveness of BETY, an exercise approach based on the biopsychosocial model, in children and adults diagnosed with scleroderma.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •*For a child diagnosed with scleroderma*
- •Inclusion Criteria:
- •Cases diagnosed with scleroderma,
- •Cases aged 7-18 years will be included.
排除标准
- •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
结局指标
主要结局
Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Patient
时间窗: Six months
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.
Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)
时间窗: Six months
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.
Modified Rodnan skin score (MRSS)
时间窗: Six months
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.
Localized Scleroderma Assessment Tool (LoSCAT)
时间窗: Six months
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.
6-Minute Walk Test
时间窗: Six months
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.
次要结局
- 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)
- Pain Catastrophizing Scale-Parent (PCS-P)(Six months)
- Scleroderma Health Assessment Questionnaire (SHAQ)(Six months)
- Short Form-36 (SF-36)(Six months)
- Turkish Eating Assessment Tool (T-EAT-10)(Six months)
- Isokinetic Muscle Measurement(Six months)
- Standard grip strength(Six months)
- Upper Extremity Proprioception Assessment(Six months)
- Vascular Structures(Six months)
- Inflammatory Markers(Six months)
- Modified Hand Mobility in Scleroderma Test (mHAMIS)(Six months)
- Maximum mouth opening (MAO)(Six months)
- Timed Up and Go Test(Six months)
- 10-Step Stair Climbing Test(Six months)
- 10-meter walk test(Six months)
- 30-second sit-to-stand test(Six months)
研究者
Orkun Tüfekçi
Principal Investigator, PT, PhD(c)
Hacettepe University