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

NCT06176846 | Unknown

• 1 other identifier: 1795570
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Juvenile Idiopathic Arthritis

Keywords

Exercise; Exergaming; Physical Fitness

Outcome Measures

Primary Outcomes (3)

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

  PACER is an adapted version of the 20 meter shuttle run test and is a field test consisting of multiple stages. The participant will run back and forth in a 20 meter area accompanied by the music coming from the voice recorder. The beep indicates when the participant should finish a lap. The test will start at slow speeds and will gradually increase each minute. The test will be terminated when the participant cannot continue to run at the level he has reached. The number of laps completed at the end of the test will be recorded. PACER is a more fun alternative to other distance running tests. It is recommended for use in children, adolescents and young adults. PACER will be used to assess the aerobic capacity of adolescents.

  Change from Baseline FitnessGram Physical Activity Test Battery-Progressive Aerobic Cardiovascular Endurance Running (PACER) at 8 weeks

• 6 Minute Walk Test (6 MWT)

  The 6-minute walk test is a well-tolerated, easy-to-apply and simple test that shows the submaximal level of functional capacity. This test measures the distance that participants can walk quickly on a hard and flat surface in 6 minutes. Participants rest in a chair near the starting position for at least 10 minutes before the start of the test. Before and after the test, heart rate, blood pressure, saturation are measured, and fatigue level is determined with the Modified Borg scale. Participants are told how to perform the test. At the end of the test, the distance walked by the participants in 6 minutes will be recorded in meters. The 6 Minute Walk Test will be used to evaluate the functional capacities of adolescents.

  Change from Baseline 6 Minute Walk Test (6 MWT) at 8 weeks

• 30 second sit to stand test (30SST)

  30 second sit to stand test is commonly used for assessing lower limb's functional capacity. Participants are asked to rise from a seated position and sit as quickly and safely as possible in 30 s. The completed number of chair stands within 30 s is counted and recorded for this test. Arms are crossed at the wrists and held against the chest. Feet place on the floor at an angle slightly back from the knees. The participant starts with "go" word and rose to a full stand and then returned to the initial seated position. The participants are encouraged to complete as many full stands as possible within a 30-second time limit. 30 second sit to stand test will be used to evaluate tower limb's functional capacity of the adolescents.

  Change from Baseline 30 second sit to stand test (30SST) at 8 weeks

Secondary Outcomes (9)

• FitnessGram Physical Activity Test Battery-Bioelectrical Impedance Analysis

  Change from Baseline FitnessGram Physical Activity Test Battery-Bioelectrical Impedance Analysis at 8 weeks

• FitnessGram Physical Activity Test Battery-Curl-up Test

  Change from Baseline FitnessGram Physical Activity Test Battery-Curl-up Test at 8 weeks]

• FitnessGram Physical Activity Test Battery-Trunk Lift Test

  Change from Baseline FitnessGram Physical Activity Test Battery-Trunk Lift Test at 8 weeks

• FitnessGram Physical Activity Test Battery-Push-up Test

  Change from Baseline FitnessGram Physical Activity Test Battery-Push-up Test at 8 weeks

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

  Change from Baseline FitnessGram Physical Activity Test Battery-Back Saver Sit and Reach Test at 8 weeks

Study Arms (2)

Immersive Virtual Reality Exergaming Group

EXPERIMENTAL

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

Behavioral: Immersive Virtual Reality Exergaming Program

Home-Based Exercise Group

EXPERIMENTAL

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

Behavioral: Home-Based Exercise Program

Interventions

Immersive Virtual Reality Exergaming Program 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.

Immersive Virtual Reality Exergaming Group

Home-Based Exercise Program 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.

Home-Based Exercise Group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (4)

Istanbul University Medical Faculty Hospital

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

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

Istanbul, Turkey (Türkiye)

RECRUITING

Umraniye Research and Training Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile; Motor Activity

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Nilay Arman, Assoc.Prof.

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

  PRINCIPAL INVESTIGATOR

• Nuray Aktay Ayaz, Prof.Dr.

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

  STUDY DIRECTOR

• Figen Cakmak, MD

  Health Science University, Cam and Sakura City Hospital

  STUDY CHAIR

• Betul Sozeri, Prof.Dr.

  Health Science University, Umraniye Research and Training Hospital

  STUDY CHAIR

• Asena Yekdaneh, MSc, Pt

  Istanbul University-Cerrahpasa, Institute of Postgraduate Education

  STUDY CHAIR

• Asya Albayrak, MSc, Pt

  Istanbul University-Cerrahpasa, Institute of Postgraduate Education

  STUDY CHAIR

• Irem Donmez, PT

  Istanbul University-Cerrahpasa, Institute of Postgraduate Education

  STUDY CHAIR

• Yusuf Acikgoz, PT

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

  STUDY CHAIR

Central Study Contacts

Nilay Arman, Assoc.Prof.

CONTACT

905534558707; nilayarman@iuc.edu.tr

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: Assoc.Prof.

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 20, 2023
• Study Start: December 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: July 1, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (4)