Cognitive Exercise Therapy Approach (BETY) in Childhood Rheumatic Diseases

Not Applicable

Not yet recruiting

• Conditions: Childhood Rheumatic Diseases; Juvenile Idiopathic Arthritis (JIA)
• Interventions: Other: BETY; Other: Control group

• Registration Number: NCT06591949
• Lead Sponsor: Hacettepe University

Brief Summary

Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY), an innovative method developed for adults with rheumatism, aims to develop behavioral change and prevent social isolation by focusing on exercises that provide pain management and functional gains in pediatric rheumatology. BETY also recognizes the importance of family education in achieving these goals. However, there is a need for studies on exercise approaches that fit the biopsychosocial model, such as BETY in childhood rheumatic diseases.

BETY is an innovative exercise approach based on the biopsychosocial model that aims to change the patient\'s cognitions through exercise developed on patients with rheumatism. This approach includes function-oriented trunk stabilization exercises, chronic pain management, and authentic dance therapy training targeting positive cognitive displacement. It is carried out in a routinized structure that continues for years on a face-to-face basis in groups and individually.

Interventions that provide physical and psychosocial support are needed in childhood rheumatic diseases. Learning to exercise the muscles surrounding the joints at the proper traction angle through exercise with BETY, gaining the ability to manage chronic pain during the day, gaining positive cognitive displacement skills, and having the opportunity to socialize through both individual and group exercises constitute the basis of the intervention.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-09
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-19
• Study Start: 2024-10-31
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients who were followed up with a diagnosis of childhood rheumatic disease in the Division of Pediatric Rheumatology, Department of Pediatrics, Hacettepe University Faculty of Medicine
• 7-18 years old
• Individuals who volunteered to participate in the study will be included.

Exclusion Criteria

• Advanced heart/lung/liver/kidney disease, neurological disease and malignancies
• Having undergone major orthopedic surgery
• Not volunteering to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BETY session group	BETY	Childhood rheumatic diseases participating in BETY sessions.
Control Group	Control group	Childhood rheumatic diseases followed up with a home exercise program.

Primary Outcome Measures

Name	Time	Method
Juvenile Arthritis Biopsychosocial Questionnaire-JAB-Q-Patient	Three months	Developed in 2018 in Turkey, it is a patient/parent-centered measurement method that helps to evaluate the biopsychosocial aspects of the patient, such as disease activity, posture, functional and psychosocial status, fatigue, performance at school. The results obtained from a total of 33 questions are used to evaluate the functional status of children, while their psychosocial status is recorded according to their answers to 21 questions. Scored between 0-164. A high score indicates a poor psychosocial status.
Juvenile Arthritis Biopsychosocial Questionnaire-JAB-Q-Family	Three months	JAB-Q is used to assess the biopsychosocial status of patients and their parents. JAB-Q is a multidimensional questionnaire with a parent (family) form. The questionnaire developed in Turkish is completed by one of the parents/persons responsible for the child. The family form assesses the biopsychosocial status of the parent from their perspective and scores between 0 and 38. Higher scores indicate worse biopsychosocial status.
Time Up and Go Test	Three months	The time between the individual getting up from a chair with back support and walking 3 meters at normal walking speed and returning to the chair is measured, and the balance status is evaluated by recording in seconds. The test is repeated three times.
Stair Climb Test	Three months	To measure the subject lower extremity strength and dynamic balance, climbing up and down ten steps of 16-20 cm stairs with a handrail as fast as possible is recorded in seconds. The test will be repeated three times, and the times will be recorded.
30 Seconds Sit to Stand Test	Three months	To evaluate the lower extremity strength, the patient is asked to stand upright on a chair with arms crossed over the chest and then sit down again. The subject is asked to repeat as fast as possible for 30 seconds. The score of this assessment test is the number of times the individual stands up fully from a sitting position with arms crossed within 30 seconds.
10-Metre Walk Test	Three months	The individual is asked to walk quickly without running on a 10-metre path. It is recorded in seconds in the evaluation made with three repetitions.

Secondary Outcome Measures

Name	Time	Method
Pain Catastrophizing Scale - Parent Version (PCS-P)	Three months	It is assessed with a 5-point Likert scale ranging from 0 (never) to 4 (always) and consists of 13 items. Parallel to the child questionnaire, it assesses three domains: rumination, magnification, and helplessness. A total score between 0-52 is obtained; higher scores reflect a higher level of catastrophizing in parents.
Child and Adolescent Scale of Participation (CASP):	Three months	It is a 20-question questionnaire that evaluates the community participation of children and adolescents in school, neighborhood, and close environments. The questionnaire includes four sub-sections: 6 questions about home participation, four about neighborhood and community participation, five about school participation, and five about home and community participation. The questionnaire rating is expected by age (full participation), somewhat limited, very limited, not applicable, and not applicable. The family of the child or primary carer completes the questionnaire. The person completing the questionnaire is asked to select the answer that best describes the participation of a child in their care. As a result, the assessment is based between 0-100 points, with higher scores describing a better level of involvement.
Juvenile Arthritis Quality of Life Questionnaire (JAQQ)	Three months	The JAQQ questionnaire can be applied to all age groups and patients with rheumatism. It comprises 74 health domains covering physical functioning, emotional well-being, and general symptoms. The items are divided into four dimensions related to the quality of life of a child: gross motor function (GMF), fine motor function (FMF), psychosocial function (PF), and systemic or general symptoms (SGS). The questionnaire provides separate scores for these four dimensions and a total JAQQ score. Each domain is scored on a Likert-type scale from 1 to 7, with higher scores indicating poorer HRQoL.; There is also a does not apply to me option for items. The scale includes a pain measure (10 cm Pain Visual Analogue Scale (VAS)) to assess pain, but this score is not included in the total.
Childhood Health Assessment Questionnaire (CHAQ)	Three months	The CHAQ assesses the functional abilities of children with JIA in activities of daily living. It consists of eight subsections (dressing and personal care, standing up, eating, walking, body care, reaching, holding, and activities). It also assesses pain and general well-being with a visual analog scale. Scores range between 0 and 3 points. A high score is an indicator of low functionality.
Pain Catastrophising Scale-Child (PPS-C)	Three months	It consists of 13 items describing different thoughts and feelings that children may experience when they feel pain. The questionnaire measures three areas: rumination, magnification, and helplessness. All items are evaluated on a 5-point Likert scale ranging from 0 (never) to 4 (always). Higher scores indicate more catastrophic pain beliefs. The total score is scored between 0 and 52.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Altındağ, Turkey