Clinical trial NCT05509907: Development of The Pediatric Physical Activity Tracking Platform (Pedi@Ctivity) and Smartwatch-based Big Data Analysis
Official title: Development of The Pediatric Physical Activity Tracking Platform (Pedi@Ctivity) and Smartwatch-based Big Data Analysis: A Digital Health Application in Society 5.0
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Adolescent
Childhood Rheumatic Disease
Keywords: Physical Activity
Exercise
Big Data
Artificial Learning
Smart Watch
Adolescent
mHealth
ehealth
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2022-08-22
Enrollment: 350
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Regular physical activity is extremely important for the protection and development of physical and psychosocial health. In addition, acquiring regular physical activity habits in the early years of life allows maintaining numerous gains related to physical fitness, functional capacity and psychoemotional health into adulthood.

Guided by scientific and technological innovations, focusing on sustainable development goals, the vision of Society 5.0 is based on digital innovation with artificial intelligence, the internet of things, digital technologies and big data, and is to increase the awareness of individuals and encourage individuals to take a role in improving their health status with wearable technology and mobile health applications. In the literature, only one study has been found on the acquisition of big data with wearable technologies for the promotion of physical activity in adolescents.

The general aim of our project is to obtain smartwatch-based big data for adolescents, which will be done for the first time in the field of health and sports in our country, and to analyze the obtained data using both statistical methods and big data analytics and artificial learning methods, to develop Pediatric Physical Activity Tracking Platform (Pedi@ktivite) through physical activity algorithms and to reveal the effect of the developed system on the physical fitness of adolescents and the usability of the system with scientific evidence. Within the scope of the project, adolescents with chronic rheumatic disease will also be included in the sample group, and the effects of the system to be developed in adolescents with the chronic rheumatic disease will be demonstrated. Due to the results obtained, we believe that this technology-supported approach will be an example of good practice for other chronic diseases.

As the first technology-supported and big data-oriented project for health and sports in adolescents, our project will fill an important gap and provide pioneering results for future projects, paving the way for providing services in the fields of health and sports with big data analytics and addressing physical inactivity.


Eligibility criteria: Inclusion Criteria:

* For Healthy Adolescent:

Adolescents aged 12-18 years who continue secondary education, Adolescents do not have any chronic diseases or disabilities Adolescents who volunteer to participate in the study

* Adolescents with chronic rheumatic disease:

Adolescents with rheumatism aged between 12-18 Adolescents with chronic rheumatic disease who volunteer to participate in the study

Exclusion Criteria:

* For Healthy Adolescent:

Adolescents who are older than 18 years of age, Adolescents who have had any discomfort or surgery that may affect their walking in the last 6 months, Adolescents and whose families are not asked to participate in the study

* Adolescents with chronic rheumatic disease:

Adolescents who are older than 18 years of age, Adolescents who have poor mental status, accompanying rheumatism and have additional neurological diagnosis that may affect the intervention results, Adolescents whose family does not want to participate in the study

Primary outcomes:
measure: Health Parameters
timeFrame: Change from Baseline Health Parameters at 12 weeks
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 12 weeks
measure: FitnessGram Physical Activity Test Battery-Bioelectrical Impedance Analysis
timeFrame: Change from Baseline FitnessGram Physical Activity Test Battery-Bioelectrical Impedance Analysis at 12 weeks
measure: FitnessGram Physical Activity Test Battery-Curl-up Test
timeFrame: Change from Baseline FitnessGram Physical Activity Test Battery-Curl-up Test at 12 weeks
measure: FitnessGram Physical Activity Test Battery-Trunk Lift Test
timeFrame: Change from Baseline FitnessGram Physical Activity Test Battery-Trunk Lift Test at 12 weeks
measure: FitnessGram Physical Activity Test Battery-Push-up Test
timeFrame: Change from Baseline FitnessGram Physical Activity Test Battery-Push-up Test at 12 weeks
measure: FitnessGram 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 12 weeks
measure: KFORCE Muscle Controller
timeFrame: Change from Baseline KFORCE Muscle Controller at 12 weeks
measure: KFORCE Plates
timeFrame: Change from Baseline KFORCE Plates at 12 weeks
measure: KFORCE Sens
timeFrame: Change from Baseline KFORCE Sens at 12 weeks
measure: Smart Insole PODOSmart (Digitsole)
timeFrame: Change from Baseline Smart Insole PODOSmart (Digitsole) at 12 weeks
measure: 6 Minute Walk Test (6 MWT)
timeFrame: Change from Baseline 6 Minute Walk Test (6 MWT) at 12 weeks
measure: Visual Analogue Scale (VAS)
timeFrame: Change from Baseline Visual Analogue Scale (VAS) at 12 weeks
measure: Exercise Stage of Change Scale Short Form
timeFrame: Change from Baseline Exercise Stage of Change Scale Short Form at 12 weeks
measure: Decisional Balance Scale in Exercise
timeFrame: Change from Baseline Decisional Balance Scale in Exercise at 12 weeks
measure: System Usability Scale
timeFrame: Change from Baseline System Usability Scale at 12 weeks
measure: Numerical Rating Scale
timeFrame: Change from Baseline Numerical Rating Scale at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Tıp Fakültesi
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 University-Cerrahpasa, Institute of Postgraduate Education
name: Asya Albayrak, Pt., MSc.
role: STUDY_CHAIR
affiliation: Istanbul University-Cerrahpasa, Institute of Postgraduate Education
name: Asena Yekdaneh, Pt., MSc.
role: STUDY_CHAIR
affiliation: MEF University, Department of Computer Engineering
name: Tuna Cakar, Assist. 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, Faculty of Sports Sciences, Department of Recreation
name: Sevim Gullu, Assoc. Prof.
role: STUDY_CHAIR
affiliation: MEF University, Graduate School of Science and Engineering,Department of Information Technologies
name: Alperen Sayar
role: STUDY_CHAIR
affiliation: MEF University, Graduate School of Science and Engineering,Department of Information Technologies
name: Tunahan Bozkan
role: STUDY_CHAIR
References: