Childhood cancer C00-D48
Conditions
Interventions
Group 1: Children and adolescents with oncological diseases during acute care, whose treatment requires regular inpatient stays with chemotherapeutic treatment. They participate in a child-specific an
each session takes 13-25 minutes.
Sponsors
Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin Abteilung Molekulare und Zelluläre Sportmedizin
Eligibility
Sex/Gender
All
Age
5 Years to 21 Years
Inclusion criteria
Inclusion criteria: - age: = 5 and = 21 years - oncological disease; treatment requires regular inpatient stays with chemotherapeutic treatment - presence of the medical consent from the treating oncologist - presence of a written informed consent from a legal guardian (participants <18 years) as well as a written informed consent from the participant
Exclusion criteria
Exclusion criteria: - physical or mental impairments that make participation in the training intervention or the functional motor tests impossible from the oncologist's point of view (including amputations or severe functional impairments of the lower extremities) - special stress circumstances (on doctor's recommendation) - lack of german language skills that don't allow understanding of the consent forms or explanations of SMT. Contraindications (leading to interruption of the training): - Thrombocytopenia (acute platelet count below 10,000mm³ or 20,000mm³ with bleeding signs - Acute thrombosis - Nausea/emesis or dizziness - Fever (=38.0°C) - During severe infections - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the perceived benefit (children and parents) of the sensorimotor training, assessed by applying a questionnaire comprising questions (1) about the perceived effectiveness of the program on selected physical performance skills, functional mobility and physical activity, (2) about their satisfaction with the sensorimotor training and (3) about feasibility of this training modality in the hospital and at home. The self-developed questionnaire is completed by study participants and their parents after the 4-week sensorimotor intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary outcomes, the development of selected physical performance skills, functional mobility and physical activity is evaluated, by assessing the following parameters before and after the intervention: - Balance ability (one-leg stand) - Functional strength of the lower extremity (sit-to-stand test, 5 repetitions) - Isometric strength of the ankle dorsiflexors (hand-held dynamometer) - Active range of motion of ankle dorsiflexion (goniometer) - Functional mobility (timed-up-and-go test, 3 meters) - Activity questionnaire Action. Furthermore, the following parameters are evaluated to asses the feasibility and safety of the training program: - Participation rate - Reasons for non-participation - Feasibility of the training sessions in terms of duration, intensity (Borg scale adapted for children), feasibility of the sensorimotor exercises and composition of sensorimotor exercises - occurrence of training-related side effects and adverse events - Children's condition before and after each training session. In addition, the following relevant medical data of the study participants will be recorded: - Diagnosis - therapy protocol and therapy methods used - cytostatic drugs used and cumulative dose at baseline - period between diagnosis/start of medical therapy and study participation - proven therapy-related side effects such as chemotherapy-induced polyneuropathy | — |
Countries
Germany
Contacts
Public ContactSarah Otten
Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin Abteilung Molekulare und Zelluläre Sportmedizin
Outcome results
None listed