Functional and Structural Outcomes Following Childhood Bone or Soft Tissue Sarcomas of the Lower Extremity (FOCUS)

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

Cross-sectional Analysis of Functional and Structural Outcomes in Children, Adolescents and Young Adults Within Follow-up of Bone or Soft Tissue Sarcomas 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. These challenges are particularly pronounced in childhood and adolescence, as they affect physiological development, resilience, and autonomy. Yet, it remains unclear whether these deficits can be fully compensated after treatment or if they result in long-term limitations, as this has not been sufficiently studied.

This bicentric study includes children and adolescents undergoing follow-up care for soft tissue or bone sarcoma of the lower extremity within 1 to 5 years since end of therapy. The cohort did not receive any specific prehabilitative training during neoadjuvant therapy. Participants will be divided into two subgroups based on the study site: (1) participants who participated in a non-specific exercise program during acute therapy and (2) participants who did not receive any exercise promotion during acute therapy. Target sample size is n=16. The study has been consented by the local ethics committee.

Several structural and functional parameters are measured to document the natural status of muscular structures and functional abilities after the treatment of a solid tumor in the lower extremities, with a focus on identifying specific deficits and the associated long-term limitations in daily life. 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 acute treatment (days of hospitalization, infection rates, etc.).

For children and adolescents, daily functionality and the experience of autonomy are crucial for physiological development and contribute significantly to quality of life. Therefore, these factors should be investigated and supported in this cohort, a group that is currently underrepresented in scientific research.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

18

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
    • Bavaria
      • Munich, Bavaria, Germany, 80337
        • Dr. von Haunersches Kinderspital, University of Munich
      • 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

Sampling Method

Non-Probability Sample

Study Population

Participants include children and adolescents during follow-up in Munich/Germany for soft tissue sarcoma or bone tumor at the lower extremity currently 1-5 years after cessation of treatment.

Description

Inclusion Criteria:

  • Cessation of treatment for a bone tumor or soft tissue sarcoma of the lower extremity 1-5 years ago
  • Age Range of 6 to 18 years
  • Treatment has been conducted at one of the two designated study sites

Exclusion Criteria:

  • Medical contraindications for testing (e.g. injury, pain, 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

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

Cohorts and Interventions

Group / Cohort
Survivors of childhood bone or soft tissue sarcomas of the lower extremity
Survivors aged 6-18 years who were treated for bone or soft tissue sarcoma of the lower extremity in one of the recruiting study sites, 1-5 years following the end of therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total psoas muscle area
Time Frame: At diagnostic procedure 1-5 years following the end of therapy
Total psoas muscle area at lumbal level (L4) analyzed via MRI or PET CT
At diagnostic procedure 1-5 years following the end of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat-free mass
Time Frame: At diagnostic procedure 1-5 years following the end of therapy

The weight of all body components excluding fat, measured in kilograms, using bioimpedance analysis.

Outcome measures 2.-6. will be combined to report body composition.
At diagnostic procedure 1-5 years following the end of therapy
Fat mass
Time Frame: At diagnostic procedure 1-5 years following the end of therapy

Total body fat weight, measured in kilograms, assessed via bioimpedance analysis.

Outcome measures 2.-6. will be combined to report body composition.
At diagnostic procedure 1-5 years following the end of therapy
Total body water
Time Frame: At diagnostic procedure 1-5 years following the end of therapy

The proportion of total body water in kg, expressed as percentage, measured through bioimpedance analysis.

Outcome measures 2.-6. will be combined to report body composition.
At diagnostic procedure 1-5 years following the end of therapy
Body cell mass
Time Frame: At diagnostic procedure 1-5 years following the end of therapy

The mass of metabolically active cells in the body, measured in kilograms, via bioimpedance analysis.

Outcome measures 2.-6. will be combined to report body composition.
At diagnostic procedure 1-5 years following the end of therapy
Phase angle
Time Frame: At diagnostic procedure 1-5 years following the end of therapy

An indicator of cellular health and membrane integrity, measured in degrees using bioimpedance analysis.

Outcome measures 2.-6. will be combined to report body composition.
At diagnostic procedure 1-5 years following the end of therapy
Muscle strength
Time Frame: At diagnostic procedure, 1-5 years following the end of therapy
Overall muscle strength measured by hand-grip dynamometry.
At diagnostic procedure, 1-5 years following the end of therapy
Range of motion of the adjacent joints
Time Frame: At diagnostic procedure, 1-5 years following the end of therapy
Range of motion of the adjacent joints measured with an analog goniometer.
At diagnostic procedure, 1-5 years following the end of therapy
Gait analysis
Time Frame: At diagnostic procedure, 1-5 years following the 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).
At diagnostic procedure, 1-5 years following the end of therapy
Path length
Time Frame: At diagnostic procedure 1-5 years following the end of therapy
The total distance traveled by the center of pressure during balance assessment, measured in centimeters using a force plate. Outcome measures 10.-13. will be combined to report balance ability.
At diagnostic procedure 1-5 years following the end of therapy
Mean velocity
Time Frame: At diagnostic procedure 1-5 years following the 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 10.-13. will be combined to report balance ability.
At diagnostic procedure 1-5 years following the end of therapy
Sway angle
Time Frame: At diagnostic procedure 1-5 years following the 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 10.-13. will be combined to report balance ability.
At diagnostic procedure 1-5 years following the end of therapy
Equlibrium score
Time Frame: At diagnostic procedure 1-5 years following the 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 10.-13. will be combined to report balance ability.
At diagnostic procedure 1-5 years following the end of therapy
Level of physical activity
Time Frame: At diagnostic procedure, 1-5 years following the end of therapy
Level of physical activity following therapy measured with the standardized ActiOn questionnaire
At diagnostic procedure, 1-5 years following the end of therapy
Quality of life
Time Frame: At diagnostic procedure, 1-5 years following the end of therapy
Quality of life during and following therapy measured with the standardized and validated KINDL questionnaire
At diagnostic procedure, 1-5 years following the 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

Investigators

  • Principal Investigator: Sabine V Kesting, Dr. rer. medic., Technical University of Munich
  • Principal Investigator: Irene von-Luettichau, Prof. Dr. med., Technical University of Munich

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)

April 1, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

December 17, 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

  • FOCUS

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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