DiaSport - Endurance-orientated Training Program With Children and Adolescents on Maintenance Hemodialysis (DiaSport)
6 de novembro de 2017 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
66
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Bonn, Alemanha, 53113
- University Hospital Bonn. Department of Pediatric and Adolescent Medicine, Division of Pediatric Nephrology
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
6 anos a 19 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Outro: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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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)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change of the possible workload (maximum physical performance) achieved
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Bernd Hoppe, MD, University Hospital of Bonn
- Cadeira de estudo: Bettina Schaar, PhD, German Sport University, Cologne
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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;:
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de setembro de 2012
Conclusão Primária (Real)
1 de outubro de 2017
Conclusão do estudo (Real)
1 de outubro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
20 de março de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de março de 2012
Primeira postagem (Estimativa)
22 de março de 2012
Atualizações de registro de estudo
Última Atualização Postada (Real)
7 de novembro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de novembro de 2017
Última verificação
1 de novembro de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Uni-Koeln-1137
- DFG HO 1272/21-1 (Número de outro subsídio/financiamento: DFG HO 1272/21-1)
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