NCT04963517

Exercise Intervention for Bone Tumor Patients

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Universität Duisburg-Essen · Academic / Other
• Sex: All
• Age: 15 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Sarcoma

Interventions

Type	Name	Description
BEHAVIORAL	Exercise therapy	8 weeks personalized, multi-modal exercise with focus on lower extremity
OTHER	Information	* Initial consultation with recommendations for general physical activity * Brochure with exercise recommendations.

Timeline

• Start date: 2021-08-07
• Primary completion: 2021-12-31
• Completion: 2022-05-01
• First posted: 2021-07-15
• Last updated: 2024-12-06

Locations

1 site across 1 country: Germany