Endurance-oriented training program with children and adolescents on maintenance hemodialysis to enhance dialysis efficacy-DiaSport.

OBJECTIVE: Pediatric patients spend significant time on maintenance hemodialysis (HD) and traveling. They are often not capable of participating in sports activities. To assess the effects of exercise training during HD on dialysis efficacy in children and adolescents, we set up a multi-center randomized controlled trial (RCT). METHODS: Patients on HD, age 6 to 18 years, were randomized either to 3× weekly bicycle ergometer training or to no training during HD for 12 weeks. Change in single-pool Kt/V (spKt/V) was the primary outcome parameter. RESULTS: We randomized 54 patients of whom 45 qualified (23 in the intervention and 22 in the waiting control group, 14.5 ± 3.01 years, 32 male and 13 female) for the intention-to-treat (ITT) population. Only 26 patients finished study per-protocol (PP). Training was performed for an average of 11.96 weeks (0.14-13.14) at 2.08 ± 0.76 times per week and for a weekly mean of 55.52 ± 27.26 min. Single-pool Kt/V was similar in the intervention compared to the control group (1.70 [0.33] vs. 1.79 [0.55]) at V0 and (1.70 [0.36] vs. 1.71 [0.51]) at V1; secondary endpoints also showed no difference in both ITT and PP analysis. No significant adverse events were reported. No bleeding or needle dislocation occurred in 1670 training sessions. CONCLUSIONS: Intradialytic bicycle training is safe, but does not improve dialysis efficacy and physical fitness. However, the study can be considered underpowered, particularly because of high dropout rates. Future studies need better strategies to increase motivation and compliance and other more effective/intensive exercise measures should be evaluated. TRIAL REGISTRATION: The trial was registered in ClinicalTrials.Gov ( Clinicaltrials.gov identifier: NCT01561118) on March 22, 2012.

Endurance training during maintenance hemodialysis in pediatric and adolescent patients-theory and best practice suggestions.

Patients on maintenance hemodialysis (HD) spend significant sedentary time traveling to and receiving dialysis, which leaves little time for social or sport events. Also, chronic HD patients are not physically fit, too exhausted after HD, and are not necessarily motivated to perform sports. There is increasing evidence that endurance training during HD can both increase dialysis efficacy and improve the ability of patients to participate in social life. With limited spare time, how can we motivate patients to train? Would that training improve endurance and modify leisure activity choice? Since HD patients would be a captive audience, we would suggest that endurance training during HD would be a preferred solution, if pediatric and adolescent patients could be persuaded to participate. There are few data on how training should be organized, as well as which parameters are best markers of safety and efficacy. And, most importantly, motivational aspects for performing endurance training on a regular basis clearly have to be considered. It is therefore in any case important to assess whether training improves endurance and, thus, quality of life or also quality of care parameters.

[Topic Check Medicine: Patient and Consumer Orientation in Topic Collection and Selection for HTA Reports]. / Der ThemenCheck Medizin: Bürgerorientierung bei der Themensammlung und der Themenauswahl für HTA-Berichte.

INTRODUCTION: The involvement of the public in the collection and selection of topics for health technology assessments (HTAs) is an important prerequisite for producing HTA reports on questions actually relevant to patients. In §139b (5) Social Code Book (SGB V), the legislator established the requirements for health insurance members and other interested individuals to propose topics for HTA reports to the Institute for Quality and Efficiency in Health Care (IQWiG). OBJECTIVES: How is the legal remit implemented with regard to the involvement of patients and consumers in topic collection and selection for HTA reports in IQWiG's Topic Check Medicine? TOPIC COLLECTION AND SELECTION: Topic proposals for HTA reports can be submitted by any interested individual via a simple submission form on the "ThemenCheck Medizin" website. If the HTA question is unclear, IQWiG consults the person submitting the proposal. On the basis of topic processing, a Selection Committee comprising members of the public and patient representatives nominates 15 patient-relevant topics suitable for the production of an HTA report. IQWiG then chooses 4-6 topics from which HTA reports are produced. EXPERIENCE WITH TOPIC COLLECTION AND SELECTION: In the first 2 selection cycles (July 2016 to July 2017), 57 topic proposals for HTA reports were submitted from a wide range of topics. At the end of 2016 and 2017, the Selection Committee nominated 15 patient-relevant topics suitable for HTA reports. At the beginning of 2017, IQWiG selected 5, at the beginning of 2018 4 topics for HTA reports. The processing of topics and the selection process were largely judged positively by the Selection Committee. CONCLUSION: A high degree of involvement in topic collection for "ThemenCheck Medizin" is achieved through the simple submission form and the nomination of topics by the Selection Committee. Furthermore, important factors for successful implementation were political support from the legislator, choice of suitable members for the Selection Committee, and support of topic selection by this Committee. How the demand for greater involvement of patients and public can be implemented needs investigation in the future.