- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01561118
DiaSport - Endurance-orientated Training Program With Children and Adolescents on Maintenance Hemodialysis (DiaSport)
DiaSport - Ausdauerorientiertes Trainingsprogramm Mit Kindern Und Jugendlichen an Der Dialyse (DiaSport - Endurance-orientated Training Program With Children and Adolescents on Maintenance Hemodialysis)
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Bonn, Niemcy, 53113
- University Hospital Bonn. Department of Pediatric and Adolescent Medicine, Division of Pediatric Nephrology
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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. |
Inny: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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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)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change of the possible workload (maximum physical performance) achieved
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Krzesło do nauki: Bernd Hoppe, MD, University Hospital of Bonn
- Krzesło do nauki: Bettina Schaar, PhD, German Sport University, Cologne
Publikacje i pomocne linki
Publikacje ogólne
- 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;:
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Uni-Koeln-1137
- DFG HO 1272/21-1 (Inny numer grantu/finansowania: DFG HO 1272/21-1)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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