An interventional study of Exercise intervention in Soft Tissue Sarcoma of the Lower Extremity, Bone Tumor of the Lower Extremity and Childhood and Adolescent Cancer, sponsored by Technical University of Munich. Active, not recruiting at 2 sites in Germany. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Technical University of Munich · Not applicable, Interventional, and Supportive care
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.
Soft tissue and bone sarcomas of the lower extremity pose significant challenges for affected individuals, often associated with considerable burden. Chemotherapy, load restrictions, and surgery frequently result in long-term physical limitations, causing structural and functional deterioration. In childhood and adolescence, these challenges are particularly pronounced, as they affect physiological development, resilience, and autonomy. Although movement promotion and therapeutic programs are designed to address these deficits, they are typically implemented post-operatively and during follow-up care. The benefit of implementing a specific program before the operative therapy remains elusive. The presented study explores the feasibility of a supervised prehabilitative training intervention and gather preliminary data on its potential effects in enhancing the pre-operative condition. The goal is to improve post-operative outcome and rehabilitation in children and adolescents diagnosed with soft tissue or bone sarcoma of the lower extremity.
This bicentric feasibility study, designed as a controlled clinical trial, enrolls all children and adolescents aged 6-18 years who are newly diagnosed with primary osteosarcoma, Ewing's sarcoma, or rhabdomyosarcoma of the lower extremity. Based on the study site, participants are allocated to either the intervention group (IG) or control group (CG), with a target sample size of 16-18. The intervention consists of specific strength and balance training sessions during neoadjuvant therapy, conducted at least twice a week for a minimum of 30 minutes per session. The CG does not receive any training intervention. The study has been consented by the local ethics committee.
The primary endpoint is the proof of feasibility of the intervention, assessed via descriptive analysis of recruitment rate, acceptance, data quality, practicability, and safety (adverse events). The secondary endpoint is the demonstration of the efficacy of the intervention comparing structural and functional measurements intra-individually and between groups at four timepoints: within ten days post-diagnosis, pre-operatively (post-intervention), at the end of therapy, and at 1-year follow-up. The measurements include psoas muscle area, body composition, strength, mobility, balance ability, gait analysis, two questionnaires on physical activity and quality of life, and quantitative measures of the clinical course during treatment (days of hospitalization, infection rates, etc.).
This study is designed to evaluate the feasibility of a specific prehabilitative training intervention in children and adolescents with soft tissue or bone sarcoma of the lower extremity. Additionally, preliminary data on the effects of this training are collected, aiming to mitigate muscle mass loss, support physiological body composition, and improve functional outcomes such as balance, gait, and physical activity. Enhancing everyday functionality and fostering a sense of autonomy can significantly improve the quality of life in this population, underscoring the importance of investigating and promoting such interventions in this underrepresented patient group.
322 studies on the registry are indexed under Bone Neoplasms; 81 are open to participants now.
This study's planned enrollment of 16 is below the median of 50 across 218 interventional studies indexed under Bone Neoplasms.
Browse Bone Neoplasms studies →Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Specific strength and balance training during neoadjuvant chemotherapy
Other: Exercise intervention
Specific strength and balance training intervention during neoadjuvant chemotherapy, twice per week for 30 min, progression according to individual status
Feasibility Criteria 1 - Recruitment Rate
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.
Time frame: At enrollment
Feasibility Criteria 2 - Acceptance
Number of performed exercise sessions during intervention period compared to intended sessions and number of performed measurements and compared to intended measurements.
Time frame: From enrollment to 12 months following end of therapy
Feasibility Criteria 3 - Data Quality
Number of evaluable exercise documentation data and measurement data.
Time frame: From enrollment to 12 months following end of therapy
Feasibility Criteria 4 - Practicability
Difference between scheduled and required time frame for the exercise sessions and measurements.
Time frame: From enrollment to 12 months following end of therapy
Feasibility Criteria 5 - Participants' Feedback
Feedback questionnaire with multiple choice options and free text answers.
Time frame: From enrollment to 12 months following end of therapy
Total psoas muscle area
Total psoas muscle area at lumbal level (L4) analyzed via MRI or PET CT
Time frame: From enrollment to 12 months following end of therapy
Fat-free mass
The weight of all body components excluding fat, measured in kilograms, using bioimpedance analysis. Outcome measures 7.-11. will be combined to report body composition.
Time frame: From enrollment to 12 months following end of therapy
Fat mass
Total body fat weight, measured in kilograms, assessed via bioimpedance analysis. Outcome measures 7.-11. will be combined to report body composition.
Time frame: From enrollment to 12 months after end of therapy
Total body water
The proportion of total body water in kg, expressed as percentage, measured through bioimpedance analysis. Outcome measures 7.-11. will be combined to report body composition.
Time frame: From enrollment to 12 months after end of therapy
Body cell mass
The mass of metabolically active cells in the body, measured in kilograms, via bioimpedance analysis. Outcome measures 7.-11. will be combined to report body composition.
Time frame: From enrollment to 12 months after end of therapy
Phase angle
An indicator of cellular health and membrane integrity, measured in degrees using bioimpedance analysis. Outcome measures 7.-11. will be combined to report body composition.
Time frame: From enrollment to 12 months after end of therapy
Muscle strength
Overall muscle strength measured by hand-grip dynamometry measured in kilograms. Reference values enable comparison with healthy children and adolescents. Higher scores imply increased muscle strength.
Time frame: From enrollment to 12 months following end of therapy.
Range of motion of the adjacent joints
Range of motion of the adjacent joints measured with an analog goniometer in degrees. Higher numbers of degrees imply better range of motion.
Time frame: From enrollment to 12 months following end of therapy
Gait analysis
Gait analysis measured with a force plate to analyze how pressure is distributed during stance phases of walking (vertical ground reaction force during loading response, mid stance, terminal stance, toe off).
Time frame: From enrollment to 12 months following end of therapy
Path length
The total distance traveled by the center of pressure during balance assessment, measured in centimeters using a force plate. Outcome measures 15.-18. will be combined to report balance ability.
Time frame: From enrollment to 12 months after end of therapy
Mean velocity
The average speed of center of pressure shifts during balance assessment, measured in meters per second with a force plate. Outcome measures 15.-18. will be combined to report balance ability.
Time frame: From enrollment to 12 months after end of therapy
Sway angle
The angular deviation of the center of pressure from a neutral position during balance tasks, measured in degrees using a force plate. Outcome measures 15.-18. will be combined to report balance ability.
Time frame: From enrollment to 12 months after end of therapy
Equlibrium score
Calculated from the anterior-posterior and medial-lateral projection of the 90% Standard Ellipse and estimated height of center of gravity during balance tasks in percentage using a force plate. Outcome measures 15.-18. will be combined to report balance ability.
Time frame: From enrollment to 12 months after end of therapy
Level of physical activity
Level of physical activity before, during and following therapy measured with the standardized ActiOn questionnaire. This tool reports individual physical activity levels and enables evaluation of meeting physical activity recommendations for children and adolescents.
Time frame: From enrollment to 12 months following end of therapy
Quality of life
Quality of life during and following therapy measured with the standardized and validated KINDL questionnaire. This tool enables evaluation of quality of life compared to reference values of healthy children and adolescents. Higher scores imply higher self-reported quality of life.
Time frame: From enrollment to 12 months following end of therapy
Quantitative measures of clinical course during treatment
Quantitative measures of clinical course during treatment (days of hospitalization, infection rates, days between surgery and start of adjuvant chemotherapy, units of physiotherapy) documented via analog and digital clinical record. This information is individual and not comparable to any reference values, however, provides important information regarding medical treatment and recovery process.
Time frame: From enrollment to 12 months following end of therapy
Plan to share: Undecided
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Technical University of Munich