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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 13 to 18 years
• All sexes
• Healthy volunteers accepted
• Child, Adult

Trial locations and contacts

4 sites in 1 country.

About this study

Official title: Effect of Immersive Virtual Reality Exergaming Program on Physical Fitness, Functional Capacity and Physical Activity In Adolescents Diagnosed With Juvenile Idiopathic Arthritis: A Randomized Controlled Study

Conditions

Juvenile Idiopathic Arthritis

Being tested

Immersive Virtual Reality Exergaming Program, Home-Based Exercise Program

Keywords

Exercise, Exergaming, Physical Fitness

Medical subject headings

Arthritis, Juvenile, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Immersive Virtual Reality Exergaming ProgramBehavioural

  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 ProgramBehavioural

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

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

2. 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.

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

3. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted20 Dec 2023
2. Study start1 Dec 2023
3. Primary completion31 Jan 2024 (estimated)
4. Study completion1 Jul 2024 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
• More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.