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DiaSport - Endurance-orientated Training Program With Children and Adolescents on Maintenance Hemodialysis (DiaSport)

6 november 2017 bijgewerkt door: Prof. Dr. B. Hoppe, University Hospital, Bonn

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

Physical activity is considered essential for optimal health, development, socialization and well-being of children. However patients with end-stage renal disease (ESRD) are often restricted from participation in exercise activities. This is especially true for children on hemodialysis (HD). As a consequence their exercise capacity is reduced, both before, but most impressively after HD. In a nationwide randomized, multi-center design this study aims to proof the influence of an individualised endurance training program by bicycle ergometer performed during dialysis on the efficacy of HD, measured as single pool Kt/V. Secondary goals are to enhance physical performance, physical and mental well-being, and to improve measurable blood and treatment parameters (e.g. haemoglobin level, amount of medication). A positive impact of physical activity was observed in adults on HD, although most studies did not address this issue in a randomised protocol. Despite this beneficial evidence in adults, sport is still not integrated as part of standard care in patients on maintenance HD. The study protocol, developed in close collaboration with the German Sport University Cologne, differs substantially from previously published reports as it uses bicycle ergometer training in an upright position outside the dialysis couch and adapts the intensity of intervention to the patient's capabilities. Based on the expected results the investigators will develop an individualised training program to be integrated in the standard care of (pediatric) patients on maintenance HD.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

66

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Duitsland
      • Bonn, Duitsland, 53113
        • University Hospital Bonn. Department of Pediatric and Adolescent Medicine, Division of Pediatric Nephrology

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

6 jaar tot 19 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • End stage renal disease with need of renal replacement therapy
  • children and adolescents aged ≥6 to ≤19 years
  • maintenance hemodialysis for at least 3 months
  • Stable and appropriate dialysis condition in the last 4 weeks before inclusion to the study (basically stable blood and dialysate flow rate and same dialyser)
  • single pool Kt/V according to Dialysestandard 2006 > 1.2
  • Informed consent

Exclusion Criteria:

  • Participation in another interventional clinical trial
  • severe primary neurologic, orthopaedic or cardiac disease, or secondary disease known as a contraindication for endurance training
  • uncontrolled hyper- or hypotension, or cardiac disease
  • Recurrent uncontrolled epileptic seizures
  • dialysis shunt at the lower limbs
  • pregnancy
  • already planned medical intervention, for example living donor kidney transplantation or any other surgery, within the first period of the trial which will cause cancelation of more then 3 training units in a row
  • Subjects who are in dependency to the sponsor or the PI of the trial, or confined to an institution on judicial or official behalf

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Bicycle-Ergometer Training Group

Performance adapted, hence individualised three times weekly bicycle-ergometer training during hemodialysis. Each training will last 30 to 50 minutes, with 70-80% of the patient specific maximum workload over 12 weeks (36 training sessions).

In the second part of the study intervention will be prolonged for another 12 weeks.
Ander: Bicycle-Ergometer Training

Performance adapted, hence individualised three times weekly bicycle-ergometer training during hemodialysis. Each training will last 30 to 50 minutes with 70-80% of the patient specific maximum workload over 12 weeks (36 training sessions - first part of the study compared to no intervention).

In the second part of the study both groups get the opportunity for another 12 weeks of individualised three times weekly bicycle-ergometer training during hemodialysis.
Ander: Control

No intervention during hemodialysis during the first 12 weeks of the study.

In the second part of the study a training program, according to that of the intervention group, will be performed with a performance adapted, hence individualised three times weekly bicycle-ergometer training during hemodialysis. Each training will last 30 to 50 minutes, with 70-80% of the patient specific maximum workload over 12 weeks (36 training sessions).
Ander: Bicycle-Ergometer Training

Performance adapted, hence individualised three times weekly bicycle-ergometer training during hemodialysis. Each training will last 30 to 50 minutes with 70-80% of the patient specific maximum workload over 12 weeks (36 training sessions - first part of the study compared to no intervention).

In the second part of the study both groups get the opportunity for another 12 weeks of individualised three times weekly bicycle-ergometer training during hemodialysis.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change of single pool Kt/V (KDOQI Guidelines) - expressed as the change of single pool Kt/V from week 0 to 12 of intervention (period 1)
Tijdsspanne: 12 weeks
Change of single pool Kt/V (spKt/V) measured at week 12 (V1) compared to baseline (V0). Single pool Kt/V is the standard measure to assess dialysis efficacy. As dialysis efficacy is the primary aim of dialysis treatment and the spKt/V is the best way to measure efficacy this figure has an important clinical relevance for the patient.
12 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change of the possible workload (maximum physical performance) achieved
Tijdsspanne: 12 and 24 weeks
The maximal possible workload will be determined by an exercise evaluation program with increasing power on a leg bicycle ergometer before a hemodialysis session, measuring the peak oxygen uptake (VO2-peak), heart rate, blood pressure and lactate levels during exercise.
12 and 24 weeks
Quality of Life
Tijdsspanne: 12 and 24 weeks
For quality of life assessment the validated and standardized PedsQL® questionnaires will be filled in by patients and parents.
12 and 24 weeks
Change of solute removal during hemodialysis
Tijdsspanne: 12 and 24 weeks
Solute removal during hemodialysis has a clear impact on the patient's health and well-being, as it reduces sequelae and offers the patient less restrictions on their diet, which would lead to a better compliance.
12 and 24 weeks
Change of solute removal in the two compartment model (assessed in a subgroup of patients)
Tijdsspanne: 12 and 24 weeks
Solute removal in the two compartment model will only be analyzed in patients 12 years of age or older with explicit consent to a second blood drawing 30 minutes after end of hemodialysis session. It was previously used showing a significant enhancement during exercise, explained by an increase of skeletal muscles perfusion during exercise.
12 and 24 weeks
Inflammation, nutritional status and bone metabolism
Tijdsspanne: 12 and 24 weeks
The nutritional status and bone metabolism will be determined as they are important for optimal health and growth of paediatric hemodialysis patients. Evidence is based on studies that showed trends towards a better nutritional status and less chronic inflammation.
12 and 24 weeks
Body Composition Monitoring (BCM)
Tijdsspanne: 12 and 24 weeks
Body Cpomposition Monitoring (BCM) will be performed to exermine further information on nutrional status, overhydration and muscle growth.
12 and 24 weeks
Change of number and dose of medication needed
Tijdsspanne: 12 and 24 weeks
Number and dose of medication will be recorded, changes will be evaluated, and data will be correlated to e.g. the measured blood pressure (antihypertensive drugs) or haemoglobin levels (EPO or EPO stimulating agents).
12 and 24 weeks
Telomere length and Telomerase activity
Tijdsspanne: 12 and 24 weeks
Telomere length and telomerase activity [units] will be used as markers for cell survival, which may be influenced by endurance training.
12 and 24 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Bonn

Medewerkers

German Sport University, Cologne

Onderzoekers

  • Studie stoel: Bernd Hoppe, MD, University Hospital of Bonn
  • Studie stoel: Bettina Schaar, PhD, German Sport University, Cologne

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2012

Primaire voltooiing (Werkelijk)

1 oktober 2017

Studie voltooiing (Werkelijk)

1 oktober 2017

Studieregistratiedata

Eerst ingediend

20 maart 2012

Eerst ingediend dat voldeed aan de QC-criteria

20 maart 2012

Eerst geplaatst (Schatting)

22 maart 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 november 2017

Laatste update ingediend die voldeed aan QC-criteria

6 november 2017

Laatst geverifieerd

1 november 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Uni-Koeln-1137
  • DFG HO 1272/21-1 (Ander subsidie-/financieringsnummer: DFG HO 1272/21-1)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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