NCT06115954

Brief Summary

Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease of unknown etiology in childhood. JIA covers several different subgroups and is predominantly manifested by peripheral arthritis. Joint swelling, effusion, tenderness, pain in JIA; causes functional limitations, fatigue and quality of life disorders. Chronic inflammation limits the patient's daily activities and productivity. Self-management is defined as an individual's ability to manage their symptoms, treatment, lifestyle changes, and the psychosocial and cultural consequences of health conditions. Good self-efficacy and coping skills reduce the health and financial burden on the individual as well as on health care, benefiting society in general. Telerehabilitation is the dissemination of rehabilitation services through communication technologies. In the literature, it is seen that the studies on internet-based exercise applications are limited. In the studies, people were encouraged to physical activity with an internet-based application and the benefits of being active were given within the scope of patient education, and it was reported that the level of physical activity effectively improved as a result. It can also increase endurance, has been reported to be safe and feasible. In our study, unlike the literature, the self-management program and exercise applications will be integrated into the internet-based telerehabilitation method, based on the fact that the exercise practices in JIA are effective in disease management and improvement of symptoms. Therefore, in our study; the effectiveness of telerehabilitation-based exercise methods to be applied additionally synchronously and asynchronously to self-management education in children and adolescents with JIA on pain, disease activity, functional status, fatigue, quality of life, psychosocial status, self-efficacy and satisfaction will be examined and compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

December 23, 2022

Completed
11 months until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

December 16, 2022

Last Update Submit

February 5, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Juvenile Idiopathic Arthritis Disease Activity Score (JADAS)

    It assess the disease activity in patients with JIA.

    Change from baseline to three months

  • Childhood Health Assessment Scale (CHAQ)

    It assess the children's functional ability over the past week.

    Change from baseline to three months

  • Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module

    It assess the patient's quality of life in pediatric arthritis.

    Change from baseline to three months

  • Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL-F)

    It assess the fatigue in children.

    Change from baseline to three months

Secondary Outcomes (4)

  • Numeric Rating Scale

    Change from baseline to three months

  • 5 times sit and stand test

    Change from baseline to three months

  • 6-Item Self-Efficacy Scale for Managing Chronic Diseases

    Change from baseline to three months

  • The Juvenile Arthritis Biopsychosocial and Clinical Questionnaire -JAB-Q

    Change from baseline to three months

Study Arms (2)

Synchronous Telerehabilitation

EXPERIMENTAL

On the basis of telerehabilitation, before starting both synchronous and asynchronous exercise therapy, a comprehensive self-management program will be provided. Self-management training will be shared online synchronously with the participants in this exercise group. The exercise program will consist of functional exercises focused on trunk stabilization, including warm-up and cool-down periods, 3 times a week for 12 weeks, and will be performed online by the physiotherapist. Exercise training will be completed with a 10-minute warm-up exercise followed by 40-minute trunk stabilization and functional exercises for the upper and lower extremities, followed by a 10-minute cooling-down program consisting of flexibility exercises. Progression in exercise training will be done by increasing the number of repetitions and adding elastic bands to the exercises.

Other: Self-Management Supported Telerehabilitation

Asynchronous Telerehabilitation

ACTIVE COMPARATOR

Self-management training will be delivered to the participants in this exercise group via video and they will be asked to watch it. The exercise program will consist of functional exercises focused on trunk stabilization, including warm-up and cool-down periods, 3 times a week for 12 weeks, and will be shared with the participants through videos taken by the physiotherapist. Exercise training will be completed with a 10-minute warm-up exercise followed by 40-minute trunk stabilization and functional exercises for the upper and lower extremities, followed by a 10-minute cooling-down program consisting of flexibility exercises. Participants will be checked weekly by phone to determine exercise tracking. Progression in exercise training will be achieved with new videos that include an increase in the number of repetitions of the participants and the addition of elastic bands to the exercises.

Other: Self-Management Supported Telerehabilitation

Interventions

Supporting the exercises with an internet-based environment and self-management training for Children and Adolescents with Juvenile Idiopathic Arthritis

Asynchronous TelerehabilitationSynchronous Telerehabilitation

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Having been diagnosed with Juvenile Idiopathic Arthritis according to ILAR diagnostic criteria
  • years old
  • Agreeing to do the exercises throughout the study
  • Stable symptoms and medications
  • Internet and computer access

You may not qualify if:

  • Be younger than 8 years old
  • Surgical or arthroscopic operation in the last 1 year
  • Having any musculoskeletal disease or orthopedic, neurological, psychological disease that may prevent participation in exercise
  • Presence of active synovitis and arthritis
  • Active vestibular disease
  • Family and patient's inability to adapt to the assessment
  • Having a psychiatric illness that affects cooperation
  • Having heart failure and lung pathology at a level that will affect activities of daily living

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University School of Physical Therapy and Rehabilitation

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bilge Basakci Calik, Prof. Dr.

    Pamukkale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc. Lecturer, Specialist Physiotherapist

Study Record Dates

First Submitted

December 16, 2022

First Posted

November 3, 2023

Study Start

December 23, 2022

Primary Completion

November 30, 2023

Study Completion

June 1, 2024

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations