Bone Tumor of the Lower Extremity, Childhood and Adolescent Cancer, Soft Tissue Sarcoma of the Lower Extremity
Conditions
Keywords
prehabilitation, bone tumor, soft tissue sarcoma, exercise intervention, childhood cancer, functional outcomes
Brief 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.
Detailed description
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.
Interventions
OTHERExercise intervention
Specific strength and balance training intervention during neoadjuvant chemotherapy, twice per week for 30 min, progression according to individual status
Sponsors
Technical University of Munich
Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Bicentric feasibility trial
Eligibility
Sex/Gender
ALL
Age
6 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body cell mass | From enrollment to 12 months after end of therapy | 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. |
| Phase angle | From enrollment to 12 months after end of therapy | 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. |
| Muscle strength | From enrollment to 12 months following end of therapy. | 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. |
| Range of motion of the adjacent joints | From enrollment to 12 months following end of therapy | Range of motion of the adjacent joints measured with an analog goniometer in degrees. Higher numbers of degrees imply better range of motion. |
| Gait analysis | From enrollment to 12 months following end of therapy | 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). |
| Path length | From enrollment to 12 months after end of therapy | 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. |
| Mean velocity | From enrollment to 12 months after end of therapy | 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. |
| Sway angle | From enrollment to 12 months after end of therapy | 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. |
| Equlibrium score | From enrollment to 12 months after end of therapy | 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. |
| Level of physical activity | From enrollment to 12 months following end of therapy | 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. |
| Quantitative measures of clinical course during treatment | From enrollment to 12 months following end of therapy | 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. |
| Quality of life | From enrollment to 12 months following end of therapy | 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. |
| Total psoas muscle area | From enrollment to 12 months following end of therapy | Total psoas muscle area at lumbal level (L4) analyzed via MRI or PET CT |
| Fat-free mass | From enrollment to 12 months following end of therapy | 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. |
| Fat mass | From enrollment to 12 months after end of therapy | Total body fat weight, measured in kilograms, assessed via bioimpedance analysis. Outcome measures 7.-11. will be combined to report body composition. |
| Total body water | From enrollment to 12 months after end of therapy | 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. |
Countries
Germany
Outcome results
None listed