Exercise in Pediatric Cancer Patient Undergoing Anti-Cancer Treatment (ONKOKIDS-HD)
11. marts 2019 opdateret af: German Cancer Research Center
Physical Activity Intervention Program for Childhood Cancer Patients Under Chemo- and/or Radiation Therapy
Today about 80% childhood cancer patients become long-time survivors.
In spite of the high cure rates the diagnosis cancer is associated with a variety of disease and treatment-related psychological and physical impairments mostly present into adulthood.
So the attention has to focus on the improvement of these problems such as motor limitation, dysfunction of the cardiovascular system, reduced muscle strength, overweight, osteoporosis and diminished quality of life (Qol).
Although exercisel intervention studies in this field are generally scarce, the results of these studies are promising.
Up to now studies during the acute phase of treatment are missing almost completely.
The aim of this feasibility study is to evaluate the potential benefits of a modular exercise intervention program for childhood cancer patients startunf in parallel with treatment and longlasting for one year.
Across two years cancer patients of the Children's Hospital of the University Clinic of Heidelberg aged 5-21 years, free of any contraindications for physical activity will be recruited.
All participants are asked to complete a physical assessment battery (strength, endurance and balance capacity, posture control, functional mobility, range of motion) and additionally two questionnaires concerning Qol and motivation, at baseline and every three months following one year
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Heidelberg, Tyskland, 69120
- Children's Hospital of the University Hospital of Heidelberg
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
5 år til 21 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- pediatric cancer diagnosis (primary leukemia, brain tumors and bone tumors
- date of diagnosis not longer than 8 weeks ago
Exclusion Criteria:
- severe cardiac impairment
- bone metastasis inducing skeletal fragility
- other orthopedic diseases or any other circumstance that would impede ability to give informed consent or adherence to study requirements.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Intervention group
Multimodal Exercise intervention (console-based training, age-specific resistance training and body awareness)
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During their inpatient hospitalization the participants perform 3-5x weekly guided training sessions about 15-30min.
The intervention includes: game console-based training using Nintendo Wii® (endurance, strength endurance and balance), age-specific resistance training and sessions of body awareness.
During the outpatient phases the participants perform a home-based exercise training 3-5x weekly using a training manual.
In addition, the patients obtain a movement diary and a pedometer for documenting their activity level.
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Ingen indgriben: Control
age, disease and gender matched
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Feasibility after 6 month
Tidsramme: after primary treatment (6 month)
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Will be measured as the proportion of patients following the exercise prescription.
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after primary treatment (6 month)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Physical performance
Tidsramme: after primary treatment (6 month) and after one year
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Strength (handheld dynamometer), endurance and balance capacity (TUDS, one leg stand), postural control functional mobility (posturomed & force plate), range of motion (goniometer)
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after primary treatment (6 month) and after one year
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Quality of Life
Tidsramme: after primary treatment (6 month) and after one year
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KINDL questionnaire
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after primary treatment (6 month) and after one year
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Feasibility between 6 and 12 month
Tidsramme: between end of primary treatment (6 month) and one year
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Will be measured as the proportion of patients following the exercise prescription.
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between end of primary treatment (6 month) and one year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Joachim Wiskemann, PhD, National Center for Tumor Diseases
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2011
Primær færdiggørelse (Faktiske)
1. december 2018
Studieafslutning (Faktiske)
1. marts 2019
Datoer for studieregistrering
Først indsendt
13. august 2014
Først indsendt, der opfyldte QC-kriterier
13. august 2014
Først opslået (Skøn)
15. august 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. marts 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. marts 2019
Sidst verificeret
1. marts 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- S105-2011
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .