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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- FitnessGram Physical Activity Test Battery-Progressive Aerobic Cardiovascular Endurance Running (PACER)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having a definitive diagnosis of JIA according to the ILAR classification at least 6 months ago
- •Being between the ages of 13-18
排除标准
- •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
结局指标
主要结局
FitnessGram Physical Activity Test Battery-Progressive Aerobic Cardiovascular Endurance Running (PACER)
时间窗: Change from Baseline FitnessGram Physical Activity Test Battery-Progressive Aerobic Cardiovascular Endurance Running (PACER) at 8 weeks
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.
6 Minute Walk Test (6 MWT)
时间窗: Change from Baseline 6 Minute Walk Test (6 MWT) at 8 weeks
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.
30 second sit to stand test (30SST)
时间窗: Change from Baseline 30 second sit to stand test (30SST) at 8 weeks
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.
次要结局
- FitnessGram Physical Activity Test Battery-Push-up Test(Change from Baseline FitnessGram Physical Activity Test Battery-Push-up Test at 8 weeks)
- Physical Activity-daily oxygen consumption(Change from the daily oxygen consumption 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)
- Physical Activity-Heart rate for daily living activities(Change from Baseline heart rate during daily living activities 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)
- Physical Activity-The number of steps taken per day(Change from the number of steps taken per day at 8 weeks)
- 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])
- Physical Activity-daily calories burned(Change from the daily calories burned at 8 weeks)
研究者
Nilay Arman
Assoc.Prof.
Istanbul University - Cerrahpasa (IUC)