Exercise Intervention for Bone Tumor Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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3D Gait Analysis to Determine Functional Limitations and Evaluate a Training Intervention in Young People With Tumor Endoprosthesis of the Lower Extremity

Conditions
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Bone Sarcoma

Intervention / Treatment
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* Behavioral: Exercise therapy
* Other: Information


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise therapy<br>8 weeks personalized, multi-modal exercise with focus on lower extremity Initial consultation with recommendations for general physical activity Brochure with exercise recommendations 2x per week multi-modal group-based and supervised exercise (endurance, strength, mobility, coordination) week 1 and 2 supervised, week 3 and 4 partially supervised, week 5 and 6 only one supervised session, week 7 and 8 last two sessions supervised | Behavioral: Exercise therapy<br>* 8 weeks personalized, multi-modal exercise with focus on lower extremity<br>* Other names: physical activity intervention;|
| Active Comparator: Information group<br>Initial consultation with recommendations for general physical activity Brochure with exercise recommendations. | Other: Information<br>* Initial consultation with recommendations for general physical activity Brochure with exercise recommendations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Profile Score | Marker based 3D gait analysis is performed on a 15m runway and recorded at 120Hz with 8 cameras from different projection angles around the runway (Vicon, Oxford, UK). Gait Profile Score is based on the averaged RMS differences in lower body kinematics (Pelvis tilt ant/post, Pelvis tilt up/down, Pelvis internal rotation/external rotation, Hip joint flexion/extension, Hip joint adduction/abduction, Hip joint internal rotation/external rotation, Knee flexion/extension, Ankle joint Dorsiflexion/Plantarflexion, Foot opening angle Internal rotation/External rotation) of subjects and kinematic reference data from a healthy population during a time normalized gait cycle. A lower GPS would indicate less deviation from a healthy populations gait pattern and thus indicate a better outcome. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Mobility | Functional Mobility Assessment score (points, score range 0 - 70, higher score = better outcome) between both study arms from T0 to T1 | 8 weeks | 
| Subjective functional outcome | Change in Musculoskeletal Tumor Society Score (questionnaire score, score range 0 - 30, higher score = better outcome) between both study arms | 8 weeks | 
| Subjective functional measure | Change in Toronto Extremity Salvage Score(questionnaire score, score range 0 - 100, higher score = better outcome) between both study arms | 8 weeks | 
| Subjective Quality of Life Adults | Change in Quality of Life (QLQ-C30 questionnaire score from 0 - 100) between both study arms | 8 weeks | 
| Subjective Quality of Life Adolescents | Change in Quality of Life (PedsQL cancer module, questionnaire score from 0 - 100) between both study arms | 8 weeks | 
| Fatigue Adults | Change in Fatigue (EORTC QLQ Fatigue questionnaire range 0 - 100, higher score = worse outcome) between both study arms | 8 weeks | 
| Range of motion | Change in affected knee range of motion (angular degree °) assessed with goniometry between both study arms | 8 weeks | 
| Gait kinematics | Changes in lower body gait kinematics between both study arms from T0 to T1 by assessing the Gait Deviation Index (GDI), measure of difference between subjects and a healthy control dataset of lower body kinematics. A GDI of 100 indicates a subject whose gait is at least as close to the healthy average as that of a randomly selected healthy individual. Thus, a GDI of 100 or higher indicates the absence of gait pathology. Every 10 points that the GDI falls below 100 corresponds one standard deviation away from the healthy populations mean. | 8 weeks | 
| Fatigue Adolescents | Change in Fatigue (PedsQL fatigue questionnaire score, range 0 - 100, higher score = worse outcome) | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, lower limb endoprosthesis, pediatric oncology, gait quality, 3D gait analysis