Evidence map›Paper›PMID 34117528›Full record

Trial reportPediatric nephrology (Berlin, Germany)2021

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

Markus Feldkötter, Sarah Thys, Anne Adams, Ingrid Becker, Rainer Büscher, Martin Pohl, Raphael Schild, Lars Pape, Claus Peter Schmitt, Christina Taylan and 8 more

Erratum issued Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Pediatric nephrology (Berlin, Germany), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01561118 (DiaSport - Ausdauerorientiertes Trainingsprogramm Mit Kindern Und Jugendlichen an Der Dialyse), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01561118 nacompletednot on this map

DiaSport - Ausdauerorientiertes Trainingsprogramm Mit Kindern Und Jugendlichen an Der Dialyse (DiaSport - Endurance-orientated Training Program With Children and Adolescents on Maintenance Hemodialysis)

TypeinterventionalSponsorUniversity Hospital, BonnRan2012 to 2017Enrolled66ConditionsEnd Stage Renal Failure on DialysisArmsBicycle-Ergometer Training
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

Markus FeldkötterPediatric Nephrology Unit, University Children's Hospital Zurich, Zurich, Switzerland.
Sarah ThysInstitute of Sport Science, Bundeswehr University Munich, Munich, Germany.
Anne AdamsInstitute of Medical Statistics and Computational Biology, University Hospital of Cologne, Cologne, Germany.
Ingrid BeckerInstitute of Medical Statistics and Computational Biology, University Hospital of Cologne, Cologne, Germany.
Rainer BüscherPediatric Nephrology, Pediatrics II, University of Duisburg-Essen, Essen, Germany.
Martin PohlDepartment of General Pediatrics, Adolescent Medicine and Neonatology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Raphael SchildPediatric Nephrology, University Children's Hospital, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Lars PapeDepartment of Pediatric Kidney, Liver and Metabolic Diseases, Hannover Medical School, Hannover, Germany.
Claus Peter SchmittDivision of Pediatric Nephrology, Center for Pediatric and Adolescent Medicine, Heidelberg, Germany.
Christina TaylanPediatric Nephrology, Children's and Adolescents' Hospital, University of Cologne, Cologne, Germany.
Simone WygodaKfH Center of Pediatric Nephrology, St Georg Hospital, Leipzig, Germany.
Günter KlausKfH Center of Pediatric Nephrology, Department of Pediatric Nephrology, Marburg, Germany.
Henry FehrenbachPediatric Nephrology, Children's Hospital, Memmingen, Germany.
Carmen MontoyaKfH Center of Pediatric Nephrology, Children's Hospital Munich Schwabing, Munich, Germany.
Martin KonradDepartment of General Pediatrics, University Children's Hospital, Münster, Germany.
Heiko BillingUniversity Children's Hospital, Tübingen, Germany.
Bettina SchaarInstitute of Sport Science, Bundeswehr University Munich, Munich, Germany.
Bernd HoppeChildren's Hospital, University of Bonn, Bonn, Germany. bernd.hoppe@knz-bonn.de.ORCID http://orcid.org/0000-0002-8120-3306

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivePediatric 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).

methodsPatients 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.

resultsWe 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.

conclusionsIntradialytic 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 registrationThe trial was registered in ClinicalTrials.Gov ( Clinicaltrials.gov identifier: NCT01561118) on March 22, 2012.

Indexed as

Endurance TrainingRenal DialysisAdolescentChildExercise TherapyFemaleHumansMaleQuality of LifeAdolescentsChildrenEndurance trainingHemodialysisspKt/VSport

Identifiers

PMID34117528
PMCPMC8599370

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.