DiaSport - Endurance-orientated Training Program With Children and Adolescents on Maintenance Hemodialysis (DiaSport)
6 novembre 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
66
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Bonn, Allemagne, 53113
- University Hospital Bonn. Department of Pediatric and Adolescent Medicine, Division of Pediatric Nephrology
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
6 ans à 19 ans (Enfant, Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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. |
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. |
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Autre: 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). |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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)
Délai: 12 weeks
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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.
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12 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change of the possible workload (maximum physical performance) achieved
Délai: 12 and 24 weeks
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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.
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12 and 24 weeks
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Quality of Life
Délai: 12 and 24 weeks
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For quality of life assessment the validated and standardized PedsQL® questionnaires will be filled in by patients and parents.
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12 and 24 weeks
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Change of solute removal during hemodialysis
Délai: 12 and 24 weeks
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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.
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12 and 24 weeks
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Change of solute removal in the two compartment model (assessed in a subgroup of patients)
Délai: 12 and 24 weeks
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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.
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12 and 24 weeks
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Inflammation, nutritional status and bone metabolism
Délai: 12 and 24 weeks
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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.
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12 and 24 weeks
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Body Composition Monitoring (BCM)
Délai: 12 and 24 weeks
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Body Cpomposition Monitoring (BCM) will be performed to exermine further information on nutrional status, overhydration and muscle growth.
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12 and 24 weeks
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Change of number and dose of medication needed
Délai: 12 and 24 weeks
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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).
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12 and 24 weeks
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Telomere length and Telomerase activity
Délai: 12 and 24 weeks
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Telomere length and telomerase activity [units] will be used as markers for cell survival, which may be influenced by endurance training.
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12 and 24 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Bernd Hoppe, MD, University Hospital of Bonn
- Chaise d'étude: Bettina Schaar, PhD, German Sport University, Cologne
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Schaar B, Feldkotter M, Nonn JM, Hoppe B. Cardiorespiratory capacity in children and adolescents on maintenance haemodialysis. Nephrol Dial Transplant. 2011 Nov;26(11):3701-8. doi: 10.1093/ndt/gfr014. Epub 2011 Mar 4.
- Hoppe B, Schaar B. The impact of nutrition and physical activity on long-term survival after pediatric solid organ transplantation. Pediatr Transplant. 2012 Nov;16(7):675-7. doi: 10.1111/j.1399-3046.2012.01663.x. Epub 2012 Feb 21. No abstract available.
- Feldkotter M, Thys S, Adams A, Becker I, Buscher R, Pohl M, Schild R, Pape L, Schmitt CP, Taylan C, Wygoda S, Klaus G, Fehrenbach H, Montoya C, Konrad M, Billing H, Schaar B, Hoppe B. Endurance-oriented training program with children and adolescents on maintenance hemodialysis to enhance dialysis efficacy-DiaSport. Pediatr Nephrol. 2021 Dec;36(12):3923-3932. doi: 10.1007/s00467-021-05114-8. Epub 2021 Jun 12. Erratum In: Pediatr Nephrol. 2021 Sep 9;:
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2012
Achèvement primaire (Réel)
1 octobre 2017
Achèvement de l'étude (Réel)
1 octobre 2017
Dates d'inscription aux études
Première soumission
20 mars 2012
Première soumission répondant aux critères de contrôle qualité
20 mars 2012
Première publication (Estimation)
22 mars 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 novembre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 novembre 2017
Dernière vérification
1 novembre 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Uni-Koeln-1137
- DFG HO 1272/21-1 (Autre subvention/numéro de financement: DFG HO 1272/21-1)
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