Immersive Virtual Reality Exergaming Program in Adolescents Diagnosed With Juvenile Idiopathic Arthritis

NCT ID: NCT06176846

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-07-01

Brief Summary

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The aim of the study is to investigate the effect of home-based exercise program versus personalized IVR exergame (Fit-XR) program on physical fitness, functional capacity and physical activity in adolescents with Juvenile idiopathic arthritis. Patients followed up by four tertiary pediatric rheumatology centers will be included in the project. Two different exercise programs will be applied to the patients by experienced physiotherapists. Fit-XR program will be 25-30 minutes a day and will be applied 2 days a week for 8 weeks under the supervision of a physiotherapist in the clinic. The total points obtained by the participants during the FiT-XR games will be recorded after each training session. In the second group, a personalized multicomponent (balance, strength, agility, endurance) home- based exercise program will be applied according to the physical fitness level of the children.

Detailed Description

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Conditions

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Juvenile Idiopathic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Immersive Virtual Reality Exergaming Group

Patients in this group will be included in an exergaming program using Oculus Quest 3 glasses.

Group Type EXPERIMENTAL

Immersive Virtual Reality Exergaming Program

Intervention Type BEHAVIORAL

Oculus Quest 3 glasses will be used as hardware for the IVR exergame program, and "Boxing", "HIIT", "Combat", "Sculpt" and Dance, among the Fit-XR games that offer virtual reality experience for fitness, will be selected according to the physical fitness level of the subjects and personalized multicomponent ( balance, strength, agility, endurance) IVR exergame program will be created. The exercise program is limited to 25-30 minutes a day and will be applied 2 days a week for 8 weeks in the clinic under the supervision of a physiotherapist. The exergaming program will be progressed according to the difficulty level, duration and technical characteristics of the games.

Home-Based Exercise Group

Patients in this group will be included in a home-based exercise program.

Group Type EXPERIMENTAL

Home-Based Exercise Program

Intervention Type BEHAVIORAL

In the home-based exercise program, a personalized multicomponent (balance, strength, agility, endurance) exercise program will be applied according to the physical fitness level of the subjects. The exercises will progress by increasing the difficulty level and number of repetitions of the exercises. An e-brochure will be given to the subjects for the exercises, the exercises will be shown to the subjects on the 1st day, and exercise control will be carried out in the 1st week and the 4th week.

Interventions

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Immersive Virtual Reality Exergaming Program

Oculus Quest 3 glasses will be used as hardware for the IVR exergame program, and "Boxing", "HIIT", "Combat", "Sculpt" and Dance, among the Fit-XR games that offer virtual reality experience for fitness, will be selected according to the physical fitness level of the subjects and personalized multicomponent ( balance, strength, agility, endurance) IVR exergame program will be created. The exercise program is limited to 25-30 minutes a day and will be applied 2 days a week for 8 weeks in the clinic under the supervision of a physiotherapist. The exergaming program will be progressed according to the difficulty level, duration and technical characteristics of the games.

Intervention Type BEHAVIORAL

Home-Based Exercise Program

In the home-based exercise program, a personalized multicomponent (balance, strength, agility, endurance) exercise program will be applied according to the physical fitness level of the subjects. The exercises will progress by increasing the difficulty level and number of repetitions of the exercises. An e-brochure will be given to the subjects for the exercises, the exercises will be shown to the subjects on the 1st day, and exercise control will be carried out in the 1st week and the 4th week.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Having a definitive diagnosis of JIA according to the ILAR classification at least 6 months ago
* Being between the ages of 13-18

Exclusion Criteria

* JIA diagnosis was made less than a month ago
* Having had a surgical or arthroscopic operation within the last year
* Presence of active synovitis or arthritis
* Have a disease that may limit the ability to exercise or increase the cardiovascular risk of exercise, including cardiovascular, pulmonary, musculoskeletal, or metabolic disorders
* Having active vestibular disease
* Having a neurological disease that prevents walking and exercising
* Having been exercising regularly for the last 6 months
* Having severe vision and hearing problems
* Use of any medication or supplement known to increase anabolic responses
* Having mental inability to understand the exercises
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Nilay Arman

Assoc.Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nilay Arman, Assoc.Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Nuray Aktay Ayaz, Prof.Dr.

Role: STUDY_DIRECTOR

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

Figen Cakmak, MD

Role: STUDY_CHAIR

Health Science University, Cam and Sakura City Hospital

Betul Sozeri, Prof.Dr.

Role: STUDY_CHAIR

Health Science University, Umraniye Research and Training Hospital

Asena Yekdaneh, MSc, Pt

Role: STUDY_CHAIR

Istanbul University-Cerrahpasa, Institute of Postgraduate Education

Asya Albayrak, MSc, Pt

Role: STUDY_CHAIR

Istanbul University-Cerrahpasa, Institute of Postgraduate Education

Irem Donmez, PT

Role: STUDY_CHAIR

Istanbul University-Cerrahpasa, Institute of Postgraduate Education

Yusuf Acikgoz, PT

Role: STUDY_CHAIR

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

Locations

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Istanbul University Medical Faculty Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Cam and Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

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

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Umraniye Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Nilay Arman, Assoc.Prof.

Role: CONTACT

905534558707

Facility Contacts

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Nuray AKTAY AYAZ, Prof.

Role: primary

Figen Cakmak, MD

Role: primary

Nilay Arman, Assoc. Prof.

Role: primary

Betul Sozeri, Prof.Dr.

Role: primary

Other Identifiers

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1795570

Identifier Type: -

Identifier Source: org_study_id

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