Soft Tissue Sarcoma of the Lower ExtremityBone Tumor of the Lower ExtremityChildhood and Adolescent Cancer
Investigational drug(s) / intervention(s)
Exercise intervention
Exercise intervention: Specific strength and balance training intervention during neoadjuvant chemotherapy, twice per week for 30 min, progression according to individual status
Study summary
This study aims to investigate the feasibility of a prehabilitative training intervention. The intervention includes specific strength and balance exercises during neoadjuvant chemotherapy with children and adolescents diagnosed with soft tissue or bone tumor in the lower extremity. This explorative approach of prehabilitation might help to reduce muscle and bone weakening and associated functional limitations during and after acute therapy. By designing this study like a controlled clinical trials, the investigators will also gather preliminary data on the intervention's potential effects in enhancing/on the pre-operative condition. The goal is to improve post-operative outcome and rehabilitation processes in children and adolescents diagnosed with soft tissue or bone sarcoma of the lower extremity.
Eligibility
Sex
ALL
Min age
6 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
* Diagnosis of a bone tumor or soft tissue sarcoma of the lower extremity
* Diagnosed less than 10 days ago, confirmed through biopsy
* Age Range of 6 to 18 years
* Treatment will be conducted at one of the two designated study sites
Exclusion Criteria:
* Medical contraindications for the implementation of the intervention and measurements, in consultation with the treating physicians (e.g., acute risk of bleeding or fractures, pain, infection, nausea, dizziness, lack of orthopedic clearance for weight-bearing in the tumor region, other acute orthopedic limitations unrelated to the underlying condition, etc.)
* Language barriers that prevent understanding of the instructions for study participation
* Cognitive impairment or developmental delay that hinders comprehension of the instructions in the testing situation, thereby preventing standardized diagnostic data collection and intervention
Primary outcome measure(s)
Feasibility Criteria 1 - Recruitment Rate — At enrollment The number of children and adolescents diagnosed with bone and soft tissue sarcoma of the lower extremity who agree to participate compared to the total number approached for this study.
Feasibility Criteria 2 - Acceptance — From enrollment to 12 months following end of therapy Number of performed exercise sessions during intervention period compared to intended sessions and number of performed measurements and compared to intended measurements.
Feasibility Criteria 3 - Data Quality — From enrollment to 12 months following end of therapy Number of evaluable exercise documentation data and measurement data.
Feasibility Criteria 4 - Practicability — From enrollment to 12 months following end of therapy Difference between scheduled and required time frame for the exercise sessions and measurements.
Feasibility Criteria 5 - Participants' Feedback — From enrollment to 12 months following end of therapy Feedback questionnaire with multiple choice options and free text answers.
Trial sites (2)
Facility
City
Region
Status
Technical University of Munich, Germany; TUM School of Medicine and Health, Department of Pediatrics. German Center for Child and Adolescent Health (DZKJ), partner site Munich
Munich
Bavaria
Dr. von Haunersches Kinderspital
Munich
Germany
More Technical University of Munich trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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