Prehabilitation in Childhood Soft Tissue or Bone Sarcomas (Prehab4Kids)

May 26, 2025 updated by: Sabine Kesting, Technical University of Munich

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 80337
        • Dr. von Haunersches Kinderspital
    • Bavaria
      • Munich, Bavaria, Germany, 80804
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At enrollment
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.
From enrollment to 12 months following end of therapy
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.
From enrollment to 12 months following end of therapy
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.
From enrollment to 12 months following end of therapy
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.
From enrollment to 12 months following end of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total psoas muscle area
Time Frame: From enrollment to 12 months following end of therapy
Total psoas muscle area at lumbal level (L4) analyzed via MRI or PET CT
From enrollment to 12 months following end of therapy
Fat-free mass
Time Frame: 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.
From enrollment to 12 months following end of therapy
Fat mass
Time Frame: 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.
From enrollment to 12 months after end of therapy
Total body water
Time Frame: 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.
From enrollment to 12 months after end of therapy
Body cell mass
Time Frame: 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.
From enrollment to 12 months after end of therapy
Phase angle
Time Frame: 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.
From enrollment to 12 months after end of therapy
Muscle strength
Time Frame: 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.
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
Range of motion of the adjacent joints measured with an analog goniometer in degrees. Higher numbers of degrees imply better range of motion.
From enrollment to 12 months following end of therapy
Gait analysis
Time Frame: 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).
From enrollment to 12 months following end of therapy
Path length
Time Frame: 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.
From enrollment to 12 months after end of therapy
Mean velocity
Time Frame: 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.
From enrollment to 12 months after end of therapy
Sway angle
Time Frame: 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.
From enrollment to 12 months after end of therapy
Equlibrium score
Time Frame: 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.
From enrollment to 12 months after end of therapy
Level of physical activity
Time Frame: 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.
From enrollment to 12 months following end of therapy
Quality of life
Time Frame: 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.
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
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.
From enrollment to 12 months following end of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Collaborators

Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2025

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

December 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 26, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prehab4Kids

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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