- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06591949
Cognitive Exercise Therapy Approach (BETY) in JIA
Investigation of the Effectiveness of Cognitive Exercise Therapy Approach (BETY) in Juvenile Idiopathic Arthritis
Cognitive Exercise Therapy Approach (*Bilişsel Egzersiz Terapi Yaklaşımı*-BETY), an innovative method developed for adults with rheumatism, aims to promote behavioral change and prevent social isolation by focusing on exercises that provide pain management and functional gains. 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, specifically developed for 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Altındağ
-
Ankara, Altındağ, Turkey (Türkiye), 06100
- Hacettepe University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with JIA,
- Aged between 7 and 18,
- Individuals who volunteered to participate in the study.
Exclusion Criteria:
- Patients with advanced heart/lung/liver/kidney disease, neurologic disease and malignancies,
- Individuals who have undergone major orthopedic surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: BETY session group
JIA patients participating in BETY sessions.
|
The cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) will be applied for 24 one-hour sessions, two days a week.
|
|
Active Comparator: Control Group
JIA patients followed up with a home exercise program.
|
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 Questionnaire-JAB-Q-Patient
Time Frame: 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.
|
Three months
|
|
Juvenile Arthritis Biopsychosocial Questionnaire-JAB-Q-Family
Time Frame: 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.
|
Three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Catastrophizing Scale - Parent Version (PCS-P)
Time Frame: 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.
|
Three months
|
|
Child and Adolescent Scale of Participation (CASP):
Time Frame: 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.
|
Three months
|
|
Childhood Health Assessment Questionnaire (CHAQ)
Time Frame: 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.
|
Three months
|
|
Pain Catastrophising Scale-Child (PPS-C)
Time Frame: 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.
|
Three months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Autoimmune Diseases
- Immune System Diseases
- Behavior
- Skin and Connective Tissue Diseases
- Arthritis, Juvenile
- Motor Activity
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Control Groups
Other Study ID Numbers
- SBA 24/1113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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