Clinical trial NCT06193681: Efficiency of Supervised Exercise Program Versus Mobile-Based Exercise Program in Juvenile Idiopathic Arthritis
Official title: The Efficiency of Supervised Exercise Program Versus Personalized Mobile-Based Exercise Program in Patients with Juvenile Idiopathic Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Keywords: Adolescents
Juvenile Idiopathic Arthritis
mobile application
ehealth
exercise
personalized exercise
mhealth
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Juvenile Idiopathic Arthritis (JIA) is a heterogeneous, idiopathic, chronic inflammatory, rheumatic disease that is most common in childhood and is thought to involve immunological mechanisms in its etiopathogenesis. Exercise and physical activity (PA) approaches have an important place in the treatment of childhood rheumatic diseases. These approaches alleviate both the symptoms of children and adolescents' chronic diseases and complications secondary to pharmacological treatments, and prevent the occurrence of new chronic diseases. However, it is difficult to draw conclusions regarding the effects of exercise types on patients with JIA, as there are few comparative studies in the literature investigating the superior effects of exercise programs on disease-specific problems.

Physical, individual, social and psychological factors that create barriers to PA and exercise participation in children and adolescents with rheumatic disease significantly affect PA and exercise adherence. In this regard, online applications stand out as an important strategy for encouraging behavioral change, providing motivational and social support, and allowing feedback and interaction with health professionals using information and communication technologies.

It is emphasized that digital health applications should be designed more comprehensively and personalized to increase participation in PA promotion and regular exercise programs and be compared with control group exercise programs in order to increase their usability in this disease population and examine their effectiveness.

This study will be planned as a randomized controlled study. Adolescent JIA patients between the ages of 12-18 will be included in the study and will be divided into 2 groups. The first group will receive a personalized exercise program under the supervision of a physiotherapist, 3 sessions per week (2 session face to face, 1 session online) for 12 weeks. A personalized mobile application-based exercise program will be applied to the second group for the same week and frequency. This study can contribute to the literature by investigating effective methods in improving physical fitness, physical activity, walking and balance functions in patients with JIA.

Adolescents in both groups will be given smart watches to promote PA and monitor health parameters. The evaluation periods for both groups are stated below; T0: Start T1: Before the exercise program (after 3 months of PA monitoring with a smart watch) T2: It will be carried out after the exercise program (12 weeks later). The effectiveness of the exercise program to be applied on the evaluation parameters will be demonstrated by comparing the two groups after the exercise program.


Eligibility criteria: Inclusion Criteria:

* Being 12-18 years old
* Being diagnosed with JIA at least 6 months ago at the Istanbul Medical Faculty Pediatric Rheumatology Clinic
* Being diagnosed with Oligoarticular/Polyarticular JIA
* Volunteering to participate in the study

Exclusion Criteria:

* Having a history of trauma or surgery affecting the musculoskeletal system in the last 6 months
* Having an additional chronic disease affecting the musculoskeletal system
* Having vision or hearing problems
* Having a level of cognitive impairment that cannot understand the commands given

Primary outcomes:
measure: FitnessGram Physical Activity Test Battery-Progressive Aerobic Cardiovascular Endurance Running (PACER)
timeFrame: Change from Baseline, Before the exercise program (after 3 months of PA monitoring with a smart watch) and after the exercise program (12 weeks later).
measure: FitnessGram Physical Activity Test Battery-Curl-up Test
timeFrame: Change from Baseline, Before the exercise program (after 3 months of PA monitoring with a smart watch) and after the exercise program (12 weeks later).
measure: FitnessGram Physical Activity Test Battery-Trunk Lift Test
timeFrame: Change from Baseline, Before the exercise program (after 3 months of PA monitoring with a smart watch) and after the exercise program (12 weeks later).
measure: FitnessGram Physical Activity Test Battery-Push-up Test
timeFrame: Change from Baseline, Before the exercise program (after 3 months of PA monitoring with a smart watch) and after the exercise program (12 weeks later).
measure: FitnessGram Physical Activity Test Battery-Back Saver Sit and Reach Test
timeFrame: Change from Baseline, Before the exercise program (after 3 months of PA monitoring with a smart watch) and after the exercise program (12 weeks later).
measure: 6 Minute Walk Test (6 MWT)
timeFrame: Change from Baseline, Before the exercise program (after 3 months of PA monitoring with a smart watch) and after the exercise program (12 weeks later).
measure: 10 Stairs Climbing Test
timeFrame: Change from Baseline, Before the exercise program (after 3 months of PA monitoring with a smart watch) and after the exercise program (12 weeks later).
measure: 1 Minute Sit to Stand Test
timeFrame: Change from Baseline, Before the exercise program (after 3 months of PA monitoring with a smart watch) and after the exercise program (12 weeks later).
Secondary outcomes:
measure: Heart Rate
timeFrame: Change from Baseline, Before the exercise program (after 3 months of PA monitoring with a smart watch) and after the exercise program (12 weeks later).
measure: Number of steps
timeFrame: Change from Baseline, Before the exercise program (after 3 months of PA monitoring with a smart watch) and after the exercise program (12 weeks later).
measure: Oxygen saturation
timeFrame: Change from Baseline, Before the exercise program (after 3 months of PA monitoring with a smart watch) and after the exercise program (12 weeks later).
measure: Daily calories
timeFrame: Change from Baseline, Before the exercise program (after 3 months of PA monitoring with a smart watch) and after the exercise program (12 weeks later).
measure: Activities
timeFrame: Change from Baseline, Before the exercise program (after 3 months of PA monitoring with a smart watch) and after the exercise program (12 weeks later).
measure: KFORCE Plates
timeFrame: Change from Baseline, Before the exercise program (after 3 months of PA monitoring with a smart watch) and after the exercise program (12 weeks later).
measure: KFORCE Muscle Controller
timeFrame: Change from Baseline, Before the exercise program (after 3 months of PA monitoring with a smart watch) and after the exercise program (12 weeks later).
measure: Digitsole Pro® system
timeFrame: Change from Baseline, Before the exercise program (after 3 months of PA monitoring with a smart watch) and after the exercise program (12 weeks later).
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa, Institute of Postgraduate Education
Study officials:
affiliation: Istanbul University-Cerrahpaşa, Faculty of Health Science, Department of Physiotherapy and Rehabilitation
name: Nilay Arman, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatric Rheumatology
name: Nuray Aktay Ayaz, Prof. Dr.
role: STUDY_CHAIR
affiliation: Istanbul University-Cerrahpasa, Institute of Postgraduate Education
name: Asena Yekdaneh
role: PRINCIPAL_INVESTIGATOR
References: