Soft Tissue Sarcoma of the Lower ExtremityPrehab4KidsNCT06743958
Prehabilitation in Childhood Soft Tissue or Bone Sarcomas
A study testing Exercise intervention in people with Soft Tissue Sarcoma of the Lower Extremity and Bone Tumor of the Lower Extremity, run by Technical University of Munich at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Soft Tissue Sarcoma of the Lower Extremity, Bone Tumor of the Lower Extremity, Childhood and Adolescent Cancer
- What is being tested?
- Exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesGermany
- Study dates
- 20 Feb 2025to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
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, 80804
Dr. von Haunersches Kinderspital
Munich, 80337
About this study
Official title: Prehabilitative Training in Children and Adolescents With Soft Tissue or Bone Sarcoma of the Lower Extremity - a Feasibility Study
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.
Read the 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.
- Conditions
- Soft Tissue Sarcoma of the Lower Extremity, Bone Tumor of the Lower Extremity, Childhood and Adolescent Cancer
- Being tested
- Exercise intervention
- Keywords
- prehabilitation, bone tumor, soft tissue sarcoma, exercise intervention, childhood cancer, functional outcomes
- Medical subject headings
- Bone Neoplasms, Sarcoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific strength and balance training intervention during neoadjuvant chemotherapy, twice per week for 30 min, progression according to individual status
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Specific strength and balance training during neoadjuvant chemotherapy Receives: Other: Exercise intervention |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to 12 months following end of therapy
Feasibility Criteria 3 - Data Quality
Number of evaluable exercise documentation data and measurement data.
Measured: 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.
Measured: From enrollment to 12 months following end of therapy
Feasibility Criteria 5 - Participants' Feedback
Feedback questionnaire with multiple choice options and free text answers.
Measured: From enrollment to 12 months following end of therapy
Secondary outcomes (16)
Total psoas muscle area
Total psoas muscle area at lumbal level (L4) analyzed via MRI or PET CT
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to 12 months following end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start20 Feb 2025
- Primary completion30 Oct 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue Sarcoma of the Lower ExtremityStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Bicentric feasibility trial
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany
- Responsible party
- Principal investigator, Sabine Kesting, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743958
- Sponsor's protocol ID
- Prehab4Kids
- Acronym
- Prehab4Kids
- Status last verified
- Aug 2026
- First submitted
- 25 Nov 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Winter CC, Muller C, Hardes J, Gosheger G, Boos J, Rosenbaum D. The effect of individualized exercise interventions during treatment in pediatric patients with a malignant bone tumor. Support Care Cancer. 2013 Jun;21(6):1629-36. doi: 10.1007/s00520-012-1707-1. Epub 2013 Jan 5.
PubMed 23292667Runco DV, Zimmers TA, Bonetto A. The urgent need to improve childhood cancer cachexia. Trends Cancer. 2022 Dec;8(12):976-979. doi: 10.1016/j.trecan.2022.07.005. Epub 2022 Aug 3.
PubMed 35931609Pilz F, Vill K, Rawer R, Bonfert M, Tacke M, Heussinger N, Muller-Felber W, Blaschek A. Mechanography in children: pediatric references in postural control. J Musculoskelet Neuronal Interact. 2022 Dec 1;22(4):431-454.
PubMed 36458382Lurz E, Patel H, Lebovic G, Quammie C, Woolfson JP, Perez M, Ricciuto A, Wales PW, Kamath BM, Chavhan GB, Juni P, Ng VL. Paediatric reference values for total psoas muscle area. J Cachexia Sarcopenia Muscle. 2020 Apr;11(2):405-414. doi: 10.1002/jcsm.12514. Epub 2020 Jan 9.
PubMed 31920002Gotte M, Gauss G, Dirksen U, Driever PH, Basu O, Baumann FT, Wiskemann J, Boos J, Kesting SV. Multidisciplinary Network ActiveOncoKids guidelines for providing movement and exercise in pediatric oncology: Consensus-based recommendations. Pediatr Blood Cancer. 2022 Nov;69(11):e29953. doi: 10.1002/pbc.29953. Epub 2022 Sep 8.
PubMed 36073842Gauss G, Beller R, Boos J, Daggelmann J, Stalf H, Wiskemann J, Gotte M. Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. Front Pediatr. 2021 Aug 19;9:682496. doi: 10.3389/fped.2021.682496. eCollection 2021.
PubMed 34490156Garcia MB, Ness KK, Schadler KL. Exercise and Physical Activity in Patients with Osteosarcoma and Survivors. Adv Exp Med Biol. 2020;1257:193-207. doi: 10.1007/978-3-030-43032-0_16.
PubMed 32483741Furtado S, Errington L, Godfrey A, Rochester L, Gerrand C. Objective clinical measurement of physical functioning after treatment for lower extremity sarcoma - A systematic review. Eur J Surg Oncol. 2017 Jun;43(6):968-993. doi: 10.1016/j.ejso.2016.10.002. Epub 2016 Oct 14.
PubMed 27836415Ehrhardt MJ, Leerink JM, Mulder RL, Mavinkurve-Groothuis A, Kok W, Nohria A, Nathan PC, Merkx R, de Baat E, Asogwa OA, Skinner R, Wallace H, Lieke Feijen EAM, de Ville de Goyet M, Prasad M, Bardi E, Pavasovic V, van der Pal H, Fresneau B, Demoor-Goldschmidt C, Hennewig U, Steinberger J, Plummer C, Chen MH, Teske AJ, Haddy N, van Dalen EC, Constine LS, Chow EJ, Levitt G, Hudson MM, Kremer LCM, Armenian SH. Systematic review and updated recommendations for cardiomyopathy surveillance for survivors of childhood, adolescent, and young adult cancer from the International Late Effects of Childhood Cancer Guideline Harmonization Group. Lancet Oncol. 2023 Mar;24(3):e108-e120. doi: 10.1016/S1470-2045(23)00012-8. Epub 2023 Feb 14.
PubMed 37052966Bhagat A, Kleinerman ES. Anthracycline-Induced Cardiotoxicity: Causes, Mechanisms, and Prevention. Adv Exp Med Biol. 2020;1257:181-192. doi: 10.1007/978-3-030-43032-0_15.
PubMed 32483740Basteck S, Guder WK, Dirksen U, Krombholz A, Streitburger A, Reinhardt D, Gotte M. Effects of an Exercise Intervention on Gait Function in Young Survivors of Osteosarcoma with Megaendoprosthesis of the Lower Extremity-Results from the Pilot Randomized Controlled Trial proGAIT. Curr Oncol. 2022 Oct 14;29(10):7754-7767. doi: 10.3390/curroncol29100613.
PubMed 36290890
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitative Training in Children and Adolescents With Soft Tissue or Bone Sarcoma of the Lower Extremity - a Feasibility Study
- ClinicalTrials.gov ID
- NCT06743958
- Acronym / sponsor ID
- Prehab4Kids / Prehab4Kids
- Conditions
- Soft Tissue Sarcoma of the Lower Extremity, Bone Tumor of the Lower Extremity, Childhood and Adolescent Cancer
- Keywords
- prehabilitation, bone tumor, soft tissue sarcoma, exercise intervention, childhood cancer, functional outcomes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Bicentric feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Exercise interventionSpecific strength and balance training during neoadjuvant chemotherapy |
| Control group | No intervention | – |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventionSpecific strength and balance training intervention during neoadjuvant chemotherapy, twice per week for 30 min, progression according to individual status | Other | Intervention group |
Primary outcome
Feasibility Criteria 1 - Recruitment Rate
Time frame: 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
Time frame: 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
Time frame: From enrollment to 12 months following end of therapy
Number of evaluable exercise documentation data and measurement data.
Feasibility Criteria 4 - Practicability
Time frame: 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
Time frame: From enrollment to 12 months following end of therapy
Feedback questionnaire with multiple choice options and free text answers.
16 secondary outcomes
Total psoas muscle area
Time frame: From enrollment to 12 months following end of therapy
Fat-free mass
Time frame: From enrollment to 12 months following end of therapy
Fat mass
Time frame: From enrollment to 12 months after end of therapy
Total body water
Time frame: From enrollment to 12 months after end of therapy
Body cell mass
Time frame: From enrollment to 12 months after end of therapy
Phase angle
Time frame: From enrollment to 12 months after end of therapy
Muscle strength
Time frame: From enrollment to 12 months following end of therapy.
Range of motion of the adjacent joints
Time frame: From enrollment to 12 months following end of therapy
Gait analysis
Time frame: From enrollment to 12 months following end of therapy
Path length
Time frame: From enrollment to 12 months after end of therapy
Mean velocity
Time frame: From enrollment to 12 months after end of therapy
Sway angle
Time frame: From enrollment to 12 months after end of therapy
Equlibrium score
Time frame: From enrollment to 12 months after end of therapy
Level of physical activity
Time frame: From enrollment to 12 months following end of therapy
Quality of life
Time frame: From enrollment to 12 months following end of therapy
Quantitative measures of clinical course during treatment
Time frame: From enrollment to 12 months following end of therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 23292667Winter CC, Muller C, Hardes J, Gosheger G, Boos J, Rosenbaum D. The effect of individualized exercise interventions during treatment in pediatric patients with a malignant bone tumor. Support Care Cancer. 2013 Jun;21(6):1629-36. doi: 10.1007/s00520-012-1707-1. Epub 2013 Jan 5.
- Background: PubMed 35931609Runco DV, Zimmers TA, Bonetto A. The urgent need to improve childhood cancer cachexia. Trends Cancer. 2022 Dec;8(12):976-979. doi: 10.1016/j.trecan.2022.07.005. Epub 2022 Aug 3.
- Background: PubMed 36458382Pilz F, Vill K, Rawer R, Bonfert M, Tacke M, Heussinger N, Muller-Felber W, Blaschek A. Mechanography in children: pediatric references in postural control. J Musculoskelet Neuronal Interact. 2022 Dec 1;22(4):431-454.
- Background: PubMed 31920002Lurz E, Patel H, Lebovic G, Quammie C, Woolfson JP, Perez M, Ricciuto A, Wales PW, Kamath BM, Chavhan GB, Juni P, Ng VL. Paediatric reference values for total psoas muscle area. J Cachexia Sarcopenia Muscle. 2020 Apr;11(2):405-414. doi: 10.1002/jcsm.12514. Epub 2020 Jan 9.
- Background: PubMed 36073842Gotte M, Gauss G, Dirksen U, Driever PH, Basu O, Baumann FT, Wiskemann J, Boos J, Kesting SV. Multidisciplinary Network ActiveOncoKids guidelines for providing movement and exercise in pediatric oncology: Consensus-based recommendations. Pediatr Blood Cancer. 2022 Nov;69(11):e29953. doi: 10.1002/pbc.29953. Epub 2022 Sep 8.
- Background: PubMed 34490156Gauss G, Beller R, Boos J, Daggelmann J, Stalf H, Wiskemann J, Gotte M. Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. Front Pediatr. 2021 Aug 19;9:682496. doi: 10.3389/fped.2021.682496. eCollection 2021.
- Background: PubMed 32483741Garcia MB, Ness KK, Schadler KL. Exercise and Physical Activity in Patients with Osteosarcoma and Survivors. Adv Exp Med Biol. 2020;1257:193-207. doi: 10.1007/978-3-030-43032-0_16.
- Background: PubMed 27836415Furtado S, Errington L, Godfrey A, Rochester L, Gerrand C. Objective clinical measurement of physical functioning after treatment for lower extremity sarcoma - A systematic review. Eur J Surg Oncol. 2017 Jun;43(6):968-993. doi: 10.1016/j.ejso.2016.10.002. Epub 2016 Oct 14.
- Background: PubMed 37052966Ehrhardt MJ, Leerink JM, Mulder RL, Mavinkurve-Groothuis A, Kok W, Nohria A, Nathan PC, Merkx R, de Baat E, Asogwa OA, Skinner R, Wallace H, Lieke Feijen EAM, de Ville de Goyet M, Prasad M, Bardi E, Pavasovic V, van der Pal H, Fresneau B, Demoor-Goldschmidt C, Hennewig U, Steinberger J, Plummer C, Chen MH, Teske AJ, Haddy N, van Dalen EC, Constine LS, Chow EJ, Levitt G, Hudson MM, Kremer LCM, Armenian SH. Systematic review and updated recommendations for cardiomyopathy surveillance for survivors of childhood, adolescent, and young adult cancer from the International Late Effects of Childhood Cancer Guideline Harmonization Group. Lancet Oncol. 2023 Mar;24(3):e108-e120. doi: 10.1016/S1470-2045(23)00012-8. Epub 2023 Feb 14.
- Background: PubMed 32483740Bhagat A, Kleinerman ES. Anthracycline-Induced Cardiotoxicity: Causes, Mechanisms, and Prevention. Adv Exp Med Biol. 2020;1257:181-192. doi: 10.1007/978-3-030-43032-0_15.
- Background: PubMed 36290890Basteck S, Guder WK, Dirksen U, Krombholz A, Streitburger A, Reinhardt D, Gotte M. Effects of an Exercise Intervention on Gait Function in Young Survivors of Osteosarcoma with Megaendoprosthesis of the Lower Extremity-Results from the Pilot Randomized Controlled Trial proGAIT. Curr Oncol. 2022 Oct 14;29(10):7754-7767. doi: 10.3390/curroncol29100613.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Soft Tissue Sarcoma of the Lower Extremity and Bone Tumor of the Lower Extremity, run by Technical University of Munich at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Criteria 1 - Recruitment Rate (time frame: At enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06743958, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.