NCT06591949

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

September 9, 2024

Last Update Submit

September 13, 2025

Conditions

Keywords

Childhood rheumatic diseasesbiopsychosocial modelBETYCognitive exercise therapy approachExercise

Outcome Measures

Primary Outcomes (2)

  • Juvenile Arthritis Biopsychosocial Questionnaire-JAB-Q-Patient

    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

    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 Outcomes (4)

  • Pain Catastrophizing Scale - Parent Version (PCS-P)

    Three months

  • Child and Adolescent Scale of Participation (CASP):

    Three months

  • Childhood Health Assessment Questionnaire (CHAQ)

    Three months

  • Pain Catastrophising Scale-Child (PPS-C)

    Three months

Study Arms (2)

BETY session group

ACTIVE COMPARATOR

JIA patients participating in BETY sessions.

Other: BETY

Control Group

ACTIVE COMPARATOR

JIA patients followed up with a home exercise program.

Other: Control group

Interventions

BETYOTHER

The cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) will be applied for 24 one-hour sessions, two days a week.

BETY session group

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

Control Group

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosed with JIA,
  • Aged between 7 and 18,
  • Individuals who volunteered to participate in the study.

You may not qualify if:

  • Patients with advanced heart/lung/liver/kidney disease, neurologic disease and malignancies,
  • Individuals who have undergone major orthopedic surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, JuvenileMotor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PT, PhD(c)

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 19, 2024

Study Start

January 15, 2025

Primary Completion

June 15, 2025

Study Completion

September 12, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Will not be shared to protect the data of individuals

Locations