NCT07234747

Brief Summary

Juvenile Idiopathic Arthritis (JIA) is the most common inflammatory, autoimmune, and chronic rheumatic disease of childhood (1). In individuals diagnosed with JIA, increased inflammation leads to joint swelling, tenderness, restricted range of motion, and pain (2,3). Over time, these symptoms may result in impaired movement and proprioception, reduced muscle strength, and gait abnormalities (2,3). Although ongoing medical treatment has been demonstrated to be highly effective in suppressing inflammation in children with rheumatic diseases, persistent pain despite treatment may limit mobility and contribute to the development of kinesiophobia. This condition may lead to the adoption of a sedentary lifestyle (4). A sedentary lifestyle may subsequently result in reduced functional capacity and physical fitness, increased risk of social isolation, and a decline in overall quality of life (5). According to the literature, physical activity in children with rheumatologic diseases has been shown to reduce inflammation, increase muscle strength, improve functional capacity and mental health, reduce fatigue, and enhance quality of life (6,7). Non-pharmacological therapeutic exercise interventions have been found effective in alleviating chronic disease-related symptoms in children and in preventing secondary complications (8). The effectiveness of exercise therapy in children with JIA has been demonstrated in several studies, with commonly used programs including balance, proprioception, resistance, and range of motion exercises (9). However, only a limited number of studies have incorporated core-focused stabilization exercises into treatment protocols for children with JIA. Although Core Stabilization Training (CST) initially gained popularity among athletes, it has since been integrated into rehabilitation programs and applied across various patient populations (10,11). CST is defined as the ability to control muscle activation in the lumbo-pelvic region, which is necessary for spinal stabilization and for transferring core strength from the trunk to the extremities. CST has been shown to positively affect standing, sitting, balance, postural stability, and gait (12). A review of the literature confirms that Core Stabilization Training (CST) has beneficial effects on quality of life, pain, cardiorespiratory fitness, and functional ability (13). In studies involving children with Juvenile Idiopathic Arthritis (JIA), CST interventions were typically applied over a period of 12 weeks, with 2-3 sessions per week. The outcomes observed in this population were consistent with findings in the broader literature, supporting the effectiveness of CST in children with JIA (14). Exergaming has emerged as an innovative approach to integrating physical activity into daily life (15). In the literature, exercise programs utilizing exergaming across various populations are frequently encountered. These studies have demonstrated multiple benefits of exergaming, including promoting physical activity, reducing perceived exertion, adapting physical activity to individual needs, and improving physical fitness (16). In children diagnosed with JIA, exergaming programs have shown improvements in physical performance and exercise skills, as well as significantly enhanced patient satisfaction (17). However, to date, no study has been identified in the literature that investigates the use of exergaming-based core stabilization training specifically in children with JIA. The aim of the study is to compare the effects of an exergaming-based core stabilization training program and a structured core stabilization training program on physical fitness and functional capacity in children with Juvenile Idiopathic Arthritis (JIA). The study is designed as a randomized controlled trial. Children diagnosed with JIA will be included and randomly assigned to one of two groups. One group will receive structured core stabilization training, while the other will receive core stabilization training through exergaming. Both interventions will be administered over a 12-week period, with sessions held twice per week, each lasting 45 minutes. To the best of available knowledge, this will be the first study to investigate the effectiveness of a core stabilization exercise program using exergaming in this population. This study is expected to contribute valuable insights to the literature on improving physical fitness and functional capacity in children with Juvenile Idiopathic Arthritis (JIA). Furthermore, it will provide the first clinical and scientific evidence regarding the innovative use of exergaming as a method for delivering core stabilization exercises.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

April 10, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

September 23, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

core stabilizationjuvenile idiopathic arthritisexergaming

Outcome Measures

Primary Outcomes (3)

  • 30-Second Sit-to-Stand Test (30STST)

    This test assesses lower limb muscle endurance and functional strength. Participants will be asked to sit and stand from a standard chair as many times as possible within 30 seconds. The total number of complete repetitions will be recorded.

    Change from baseline and after the exercise program (12 weeks later).

  • 6-Minute Walk Test (6MWT)

    The 6MWT evaluates submaximal aerobic capacity and functional endurance. Participants will be instructed to walk continuously for 6 minutes down a 30-meter corridor. The total distance covered in meters will be recorded.

    Change from Baseline and after the exercise program (12 weeks later).

  • 10-Step Stair Climb Test

    This test measures functional lower extremity strength and mobility. Participants will be asked to ascend 10 stairs as quickly and safely as possible. The time to complete the stair climb will be measured in seconds using a stopwatch.

    Change from Baseline and after the exercise program (12 weeks later).

Secondary Outcomes (12)

  • FitnessGram Physical Activity Test Battery-Curl-up Test

    Change from baseline and after the exercise program (12 weeks later).

  • FitnessGram Physical Activity Test Battery-Push-up Test

    Change from baseline and after the exercise program (12 weeks later).

  • FitnessGram Physical Activity Test Battery-Back Saver Sit and Reach Test

    Change from baseline and after the exercise program (12 weeks later).

  • FitnessGram Physical Activity Test Battery-Trunk Lift Test

    Change from baseline and after the exercise program (12 weeks later).

  • FitnessGram Physical Activity Test Battery-Progressive Aerobic Cardiovascular Endurance Running (PACER)

    Change from baseline and after the exercise program (12 weeks later).

  • +7 more secondary outcomes

Study Arms (2)

Structured Core Stabilization Exercise Training

EXPERIMENTAL
Other: Structured Core Stabilization Exercise Training

Exergaming-Based Core Stabilization Training

EXPERIMENTAL
Other: Exergaming-Based Core Stabilization Training

Interventions

This group is currently undergoing a structured core stabilization training program, consisting of supervised exercises conducted twice a week for 45 minutes per session over a 12-week period. The training is performed on a balance board to enhance postural control and trunk stability. The core-focused exercises include quadruped stabilization, extremity lifts in crawling position, planks, push-ups, mountain climbers, squats, single-leg squats, and lunges. These exercises are designed to strengthen deep trunk muscles and improve neuromuscular coordination, balance, and overall functional movement. Sessions are supervised by a physiotherapist to ensure correct execution and progression.

Structured Core Stabilization Exercise Training

This group is currently participating in an exergaming-based core stabilization training program using the SEG-BOARD device, developed under the TÜSEB B Project. The program is conducted twice a week for 45 minutes per session over a 12-week period. Although the SEG-BOARD is not specifically designed for core stabilization, it is a general-purpose exergaming exercise platform. In this study, it is utilized to support core-focused training through interactive visual and auditory feedback that promotes engagement and motor control. Participants perform exercises targeting core strength and stability, including quadruped-position stabilization, extremity lifts, planks, push-ups, mountain climbers, squats, single-leg squats, and lunges. These exercises are adapted into the exergaming format to enhance motivation and participation, while supporting improvements in trunk control and postural stability. All sessions are supervised by a physiotherapist.

Exergaming-Based Core Stabilization Training

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Being between the ages of 8 and 13
  • Having been diagnosed with JIA at least 6 months prior
  • Willingness to participate in the study

You may not qualify if:

  • Having a balance problem due to vestibular or neurological conditions
  • Having undergone surgery in the last 6 months that may interfere with exercise participation
  • Inability to comply with the exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University - Cerrahpasa

Istanbul, Buyukcekmece, 34500, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nilay Arman, Assoc. Prof. Dr.

    Istanbul University-Cerrahpaşa, Faculty of Health Science, Department of Physiotherapy and Rehabilitation, Istanbul, Türkiye

    STUDY DIRECTOR
  • Nuray Aktay Ayaz, Prof. Dr.

    Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatric Rheumatology, Istanbul, Türkiye.

    STUDY CHAIR
  • Figen Cakmak, Assoc. Prof. Dr.

    Istanbul Basaksehir Cam ve Sakura City Hospital, Department of Pediatric Rheumatology, Istanbul, Türkiye.

    STUDY CHAIR
  • Irem Donmez, Pt.

    Istanbul University-Cerrahpasa, Institute of Graduate Studies, Physiotherapy and Rehabilitation Master of Science Program, Istanbul, Türkiye.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irem Donmez, Pt.

CONTACT

Nilay Arman, Assoc. Prof. Dr.

CONTACT

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
Physiotherapist

Study Record Dates

First Submitted

September 23, 2025

First Posted

November 18, 2025

Study Start

April 10, 2025

Primary Completion

November 10, 2025

Study Completion

January 10, 2026

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations