Childhood cancer C00-D48
Conditions
Interventions
Group 1: Intervention group 1 (IG1, n=5): Children and adolescents (10–23 years) with oncological/haematological diseases during acute medical treatment. They participate in a single child-friendly an
Sponsors
Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abteilung Molekulare und Zelluläre Sportmedizin
Eligibility
Sex/Gender
All
Age
10 Years to 23 Years
Inclusion criteria
Inclusion criteria: o Age: = 10 years - = 23 years o Body height: = 140 cm - = 200 cm (ICAROS® manufacturer’s specification) o Body weight: = 110 kg (ICAROS® manufacturer’s specification) o Oncological or haematological diagnosis o Medical consent from the treating oncologist to take part in the study o Written informed consent from at least one parent or legal guardian (for participants <18 years) o Written informed consent from the participant IG1: o Acute medical treatment at the time of intervention o Medical Treatment at the Center for Pediatric and Adolescent Medicine at Helios Hospital Krefeld IG2: o Acute medical treatment completed at the time of intervention o Medical Treatment (acute therapy, maintenance therapy, if applicable) & aftercare at the Center for Pediatric and Adolescent Medicine at Helios Hospital Krefeld
Exclusion criteria
Exclusion criteria: - Physical or severe mental impairments that make participation impossible from the oncologist's point of view (e.g. amputation or other significant functional impairment of the lower extremities, possible risk of tumour fracture/rupture, or visual impairments) - Special circumstances (on medical advice) - Insufficient knowledge of German language, making it impossible to understand the informed consents or the training and testing procedures Contraindications (leading to postponement of training and testing) IG1 and IG2: - Thrombocytopenia (acute platelet counts below 10,000³ or 20,000 mm³ with bleeding signs) - Acute thrombosis - Nausea/emesis or dizziness - Fever (= 38,0°C) - Severe pain or pain the increases under stress - During severe infections - Sedation or surgery on the same day - Up to 7 days after minor surgical procedures - At least 2 weeks after major surgical procedures - Injuries of muscles, tendons, ligaments, joints, or bones that make participation temporarily impossible - Weakness, very poor overall condition – according to medical advice ICAROS® manufacturer's information according to the instructions for use: - Fatigue or dizziness – as directed by the treating oncologist in consultation with the experienced sports scientist - Health restrictions – as determined by the treating oncologist in consultation with the experienced sports scientist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Primary aim of the study is to investigate the feasibility and safety of a training session on the ICAROS Cloud with children during and after acute oncological treatment. - The following parameters will be documented within the scope of feasibility o Participation data o Feasibility of training sessions (duration, intensity (modified BORG scale, 1-10), contents of the training sessions and occurrence of adverse events that are related to the intervention o Reasons for termination of the training session o Reasons for non-participation in the study | — |
Secondary
| Measure | Time frame |
|---|---|
| - As secondary outcome, participants’ satisfaction with the training session will be evaluated: o Physical Activity Enjoyment Scale (16-item PACES, Motl et al., 2001) - In addition, the effect of the single training session on the ICAROS Cloud during and after acute pediatric oncological therapy on balance ability will be assessed Balance ability is assessed using the following methods: o One-leg stance (t-bar) o Performance test on the ICAROS Cloud “Balance Two Feet Test” - Furthermore, following relevant medical data of the participants will be documented: o Diagnosis o Therapeutic methods used o period between diagnosis/therapy start or therapy completion and study participation | — |
Countries
Germany
Contacts
Public ContactSarah Otten
Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abteilung Molekulare und Zelluläre Sportmedizin
Outcome results
None listed