Clinical trial NCT04963517: Exercise Intervention for Bone Tumor Patients
Official title: 3D Gait Analysis to Determine Functional Limitations and Evaluate a Training Intervention in Young People with Tumor Endoprosthesis of the Lower Extremity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bone Sarcoma
Keywords: exercise
lower limb endoprosthesis
pediatric oncology
gait quality
3D gait analysis
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: Ruhr University of Bochum
First posted: 2021-07-15
Enrollment: 11
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The proGait-study is a two-arm exercise intervention study for AYA-patients with lower extremity tumor endoprosthesis in the follow-up care. This clinical trial will investigate the effects of an 8-week personalized multi-modal exercise intervention of lower extremity muscles on gait quality in adolescents and young adults with cancer diagnosis beginning at least 12 months after endoprosthesis implantation.

Detailed description: The main objective of the proGait-study is to investigate the effects of an 8-week personalized, partially supervised exercise program for lower extremity muscles on gait kinematics of adolescents and young adults, who are in follow-up care after cancer treatment and at least 12 months after endoprosthesis implantation. This randomized controlled trial will include n=20-30 patients. Patients will be randomly assigned to the intervention or control group. Patients in the intervention group will perform two supervised exercise sessions in week one and two. In the following weeks, they will perform in a mix of supervised and unsupervised exercise sessions to introduce the patients into independent exercise. Both groups receive recommendations for individual lower extremity exercise. Secondary aims of this interventional study are to evaluate functional mobility, knee range of motion and patient-reported outcomes including QoL and fatigue.

Eligibility criteria: Inclusion Criteria:

* Adolescents and young adults between 15 and 45 years of age
* Completion of acute cancer treatment and receiving follow-up care in Essen (University Hospital Essen)
* At least 12 months post endoprosthesis implantation
* Signed informed consent (Parents and Patient)

Exclusion Criteria:

* \<15 years of age, \>45 years of age
* time post implantation \<12 months
* Medical condition that limits participation in one of the study arms
* Inability to follow the training-protocol

Primary outcomes:
measure: Gait Profile Score
timeFrame: 8 weeks
Secondary outcomes:
measure: Functional Mobility
timeFrame: 8 weeks
measure: Subjective functional outcome
timeFrame: 8 weeks
measure: Subjective functional measure
timeFrame: 8 weeks
measure: Subjective Quality of Life Adults
timeFrame: 8 weeks
measure: Subjective Quality of Life Adolescents
timeFrame: 8 weeks
measure: Fatigue Adults
timeFrame: 8 weeks
measure: Range of motion
timeFrame: 8 weeks
measure: Gait kinematics
timeFrame: 8 weeks
measure: Fatigue Adolescents
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
state: NRW
Study officials:
affiliation: University Hospital, Essen
name: Miriam Götte, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Basteck 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.