Clinical trial NCT06176846: Immersive Virtual Reality Exergaming Program in Adolescents Diagnosed With Juvenile Idiopathic Arthritis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Keywords: Exercise
Exergaming
Physical Fitness
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: FitnessGram Physical Activity Test Battery-Progressive Aerobic Cardiovascular Endurance Running (PACER)
timeFrame: Change from Baseline FitnessGram Physical Activity Test Battery-Progressive Aerobic Cardiovascular Endurance Running (PACER) at 8 weeks
measure: 6 Minute Walk Test (6 MWT)
timeFrame: Change from Baseline 6 Minute Walk Test (6 MWT) at 8 weeks
measure: 30 second sit to stand test (30SST)
timeFrame: Change from Baseline 30 second sit to stand test (30SST) at 8 weeks
Secondary outcomes:
measure: FitnessGram Physical Activity Test Battery-Bioelectrical Impedance Analysis
timeFrame: Change from Baseline FitnessGram Physical Activity Test Battery-Bioelectrical Impedance Analysis at 8 weeks
measure: FitnessGram Physical Activity Test Battery-Curl-up Test
timeFrame: Change from Baseline FitnessGram Physical Activity Test Battery-Curl-up Test at 8 weeks]
measure: FitnessGram Physical Activity Test Battery-Trunk Lift Test
timeFrame: Change from Baseline FitnessGram Physical Activity Test Battery-Trunk Lift Test at 8 weeks
measure: FitnessGram Physical Activity Test Battery-Push-up Test
timeFrame: Change from Baseline FitnessGram Physical Activity Test Battery-Push-up Test at 8 weeks
measure: Physical Activity Test Battery-Back Saver Sit and Reach Test
timeFrame: Change from Baseline FitnessGram Physical Activity Test Battery-Back Saver Sit and Reach Test at 8 weeks
measure: Physical Activity-Heart rate for daily living activities
timeFrame: Change from Baseline heart rate during daily living activities at 8 weeks
measure: Physical Activity-The number of steps taken per day
timeFrame: Change from the number of steps taken per day at 8 weeks
measure: Physical Activity-daily calories burned
timeFrame: Change from the daily calories burned at 8 weeks
measure: Physical Activity-daily oxygen consumption
timeFrame: Change from the daily oxygen consumption at 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Medical Faculty Hospital
city: Istanbul
country: Turkey
facility: Cam and Sakura City Hospital
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa, Faculty of Health Science, Department of Physiotherapy and Rehabilitation
city: Istanbul
country: Turkey
facility: Umraniye Research and Training Hospital
Study officials:
affiliation: Istanbul University-Cerrahpaşa, Faculty of Health Science, Department of Physiotherapy and Rehabilitation
name: Nilay Arman, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatric Rheumatology
name: Nuray Aktay Ayaz, Prof.Dr.
role: STUDY_DIRECTOR
affiliation: Health Science University, Cam and Sakura City Hospital
name: Figen Cakmak, MD
role: STUDY_CHAIR
affiliation: Health Science University, Umraniye Research and Training Hospital
name: Betul Sozeri, Prof.Dr.
role: STUDY_CHAIR
affiliation: Istanbul University-Cerrahpasa, Institute of Postgraduate Education
name: Asena Yekdaneh, MSc, Pt
role: STUDY_CHAIR
affiliation: Istanbul University-Cerrahpasa, Institute of Postgraduate Education
name: Asya Albayrak, MSc, Pt
role: STUDY_CHAIR
affiliation: Istanbul University-Cerrahpasa, Institute of Postgraduate Education
name: Irem Donmez, PT
role: STUDY_CHAIR
affiliation: Istanbul University-Cerrahpaşa, Faculty of Health Science, Department of Physiotherapy and Rehabilitation
name: Yusuf Acikgoz, PT
role: STUDY_CHAIR
References: