C81-C96
Conditions
Interventions
Group 1: Multimodal training program (target volume of at least 60 minutes per week) over a period of 8 weeks along with a nutritional counselling.
Group 2: Sham-exercise intervention with non-metabol
Sponsors
Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin
Eligibility
Sex/Gender
All
Age
10 Years to 17 Years
Inclusion criteria
Inclusion criteria: Initial diagnosis of acute lymphocytic leukemia, non-Hodgkin B lymphoma, non-Hodgkin lymphoblastic lymphoma, or Hodgkin lymphoma who are initially treated with high-dose corticosteroids at Frankfurt University Hospital, Clinic for Paediatrics and Adolescent Medicine. Written consent from parent or guardian.
Exclusion criteria
Exclusion criteria: Cognitive impairment, insufficient language skills in German or English, medically determined incapability for sports at the time of diagnosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Ultrasonography of visceral fat thickness* - Ultrasonography of muscle thickness (M. rectus femoris und M. vastus intermedius)* - postprandial blood glucose** - HOMA (Homeostatic model assessment)** - MOON-Test Item Sit-to-Stand* - Steep Ramp Protocol* - MOON-Test Item Hand grip strength* *Data assessment: Baseline, week 4 und week 8 (intervention end) **Erhebungszeitpunkte: Baseline, week 1, week 4 und week 8 (intervention end) | — |
Secondary
| Measure | Time frame |
|---|---|
| Motor functions (secondary) - MOON-Test Item Static balance - MOON-Test Item Medicine ball shot - Finger Tapping - Standing long jump Body composition (secondary) - Body Mass Index - Waist-to-height ratio Metabolic health (secondary) - Triglycerides - Cholesterols (LDL, HDL, total cholesterol) - Hba1c - Incidence hyperglycemia (defined as two or more routinely documented blood glucose measurements >200 md/dl) - Brief questionnaire on nutritional quality - Stool normal/ abnormal Serum biomarker (Safety parameters) - C-reactive protein (CRP) - Thrombocytes - Hemoglobin - Neutrophilic granulocytes - Creatine kinase - Albumin - Risk group according to therapy protocol Feasibility outcomes - Achievement of the recruitment target n=10-15 - consent rate and reasons for non-consent - Dropout number and reasons - Number of completed training units and reasons for non-completion - Average training effectiveness - Number and reasons for adverse events - Data completion rate and and reasons for missing assessments - Feasibility questionnaire for medical personnel - Feasibility questionnaire physiotherapists and sports therapists - Feasibility questionnaire parents and patients | — |
Countries
Germany
Contacts
Public ContactMirjam Dieckelmann
Universitätsklinikum Frankfurt
Outcome results
None listed