Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

6 novembre 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

66

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 6 anni a 19 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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.
Altro: 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).
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change of the possible workload (maximum physical performance) achieved
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Bonn

Collaboratori

German Sport University, Cologne

Investigatori

  • Cattedra di studio: Bernd Hoppe, MD, University Hospital of Bonn
  • Cattedra di studio: Bettina Schaar, PhD, German Sport University, Cologne

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2012

Completamento primario (Effettivo)

1 ottobre 2017

Completamento dello studio (Effettivo)

1 ottobre 2017

Date di iscrizione allo studio

Primo inviato

20 marzo 2012

Primo inviato che soddisfa i criteri di controllo qualità

20 marzo 2012

Primo Inserito (Stima)

22 marzo 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 novembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 novembre 2017

Ultimo verificato

1 novembre 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Uni-Koeln-1137
  • DFG HO 1272/21-1 (Altro numero di sovvenzione/finanziamento: DFG HO 1272/21-1)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi