German Clinical Trials Register

Acronym/abbreviation of the study

Beware

URL of the study

https://www.rheuma-kinderklinik.de/rheuma-zentrum/so-behandeln-wir/bewegungsanalyse/beware-projekt

Brief summary in lay language

Approximately 1,500 children and adolescents develop a juvenile type of rheumatism, the Juvenile Idiopathic Arthritis, in Germany each year. The inflammations in the joints affect everyday functionality, quality of life as well as physical activity. Despite significant improvements in drug treatment, around one-quarter of affected adolescents face long-term restrictions on everyday movements. It is believed that some of these long-term consequences can be avoided by appropriate movement support. However, there is uncertainty among physicians regarding the use of functional diagnostics to assess sports participation and the earliest possible use of active exercise therapy together with sport. As part of the project, special motion analysis will be used and an IT-based sports recommendation tool for children with rheumatism will be developed. In addition, the effect of this early sports recommendation is examined in comparison to the currently often practiced sports partial exemption. 125 children and adolescents with rheumatism will be medically assisted for up to two years and examined two to three times. In half of these children, the differentiated sports advice (sports advice tool) is used. The comparison group receives a standard care and recommendation for sport. Health status, motor performance and quality of life are compared. After successful completion of the study, pediatric rheumatologists and paediatricians in the German-speaking area should be provided with a counseling tool to advise all affected children and adolescents on the right and safe sports to prevent long-term restrictions.

Brief summary in scientific language

Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in children and adolescents with predominant involvement of the joints and tendons. The disease often causes a circle of pain and inflammation, leading to functional restraints, muscular imbalances and restrictions in everyday movements as well as specific malpositions. In addition, this often results in an increase in physical and athletic inactivity with long-term deficits in motor abilities, which also persist after an inactive disease status. The patients bear a long-term increased risk of misuse and overloading of the musculoskeletal system, which increase distinctively, especially during sports, movements. In addition to the personal (psycho-social) perspective of the patients, a corresponding risk assessment of functional deficits is also of crucial importance in terms of health economics. Established children's rheumatism scores do not consider this, so that in addition to the clinical diagnostics movement diagnostics should be used. The results of the risk assessment of functional deficits can flow into an individual sports recommendation. There is an urgent need for research. The protocol of the planned prospective cohort and intervention study aims to evaluate criteria for the use of appropriate functional diagnostic methods with sports recommendation for JIA patients. Project results are indication criteria that lead to a more efficient use of resources in functional diagnostics, and a computer-based sports recommendation tool. Above all, the need-based care of patients with functional limitations should benefit. The goals are to improve the motor skills and quality of life of these patients. The study is conducted at the German Center for Pediatric and Adolescent Rheumatology (DZKJR). A mixed methods approach with randomized control group design for effects checking quantitative and qualitative data collections as well as an exploratory study design for the identification of functional deficits will be chosen. In addition, at the end of the study there will be a health economic evaluation of the costs and benefit parameters. About 125 newly diseased JIA patients with at least one actively affected joint will be recruited for 36 months and examined clinically as well as motion diagnostically on at two to three inpatient hospital stays. The established methods of three-dimensional (3D) motion analysis and the Deutsche Motorik Test (DMT) are used for differentiated motion diagnostics. Patients can be enrolled at two points in the study. At t0, newly diagnosed JIA-Patients with at least one affected joint aged 6-16 years can are included and will take part in three clinical visits t0, t1, t2 (stays are independent of the study). A change of protocol was made to also include pre-treated patients to enter the study at t1. Patients have to reach an inactive state of disease and fulfil the inclusion criteria of t0 in hindsight, as if they would have been at the clinic earlier (t0). From that point on (t1/t1’), this cohort (t1’) will fulfil the same study protocol as the patients included at t0. At t1/t1’, a stratified randomization into two intervention groups takes place with the onset of an inactive disease phase. This measurement will take place up to 14 months after t0 or at the point of inclusion for t1’-patients. Patients, who were included at t0, have to be checked for an inactive state of disease after max. 12 months. Then, they have an additional two months to come back to the clinic. This extension was made due to the Covid-19 pandemic. One of the intervention groups receives an individual sports recommendation based on the results of the movement diagnostics and the subjective self-assessment of the patient as well as the assessment of the therapist / tester (intervention a). There is a comparison to the group with a current standard sport recommendation (intervention b, general description of sport limitations). At the last measurement, the motor performance change will be checked within 3-9 months in both intervention groups. The duration of the intervention phase was extended from 3-6 to 3-9 months due to Covid-19. At this appointment, all patients receive individual sports advice (intervention a). In order to monitor the state of health and physical activity in the phases between hospital stays, patients take weekly/monthly surveys using TUM / DZKJR’s own WebApp. Since May 2020 an additional questionnaire is used to examine constraints regarding their physical activity during the intervention phase due to the Covid-19 pandemic. The primary endpoint of the study is to improve the function of JIA patients with a functional deficit through optimal sports recommendation. The secondary endpoint is a consistent minimal inflammatory activity and pain intensity as well as an improvement in health-related quality of life. At the end of the study, the sports recommendation tool will be adjusted on the basis of the study results and transferred to a software application.