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

Abstract

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.

Keywords: Adolescents; Children; Endurance training; Hemodialysis; Sport; spKt/V.

© 2021. The Author(s).

Figures

Fig. 1

Study schedule: After screening and randomization of the patient, three times weekly bicycle ergometer training during hemodialysis for up to 50 to 70 min (warm up, endurance training, cool down) duration and with 70–80% of the patient-specific maximum workload during 12 weeks was performed twice in the intervention group (periods I and II). In the waiting control group, no ergometer training was performed during the first 12 weeks (period I); training was then performed in intervention period II

Fig. 2

Patient flow intention-to-treat (ITT) population

Fig. 3

Patient flow per-protocol (PP) population

Fig. 4

Primary endpoint: Mean single-pool Kt/V at different testing points, ITT (intention-to-treat population), LOCF (last observation carried forward). V0 baseline, V1 post first intervention period (12 weeks), V2 post second intervention period (24 weeks)

Fig. 5

Exemplary secondary endpoint: mean elimination of low molecular substances—no changes between V0 and V2 for blood urea, serum creatinine, serum phosphate, and mean double-pool Kt/V