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NCT Number: NCT04963517

Exercise Intervention for Bone Tumor Patients

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.

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Key information

Conditions

Bone Sarcoma Behavior Bone Diseases Bone Neoplasms Motor Activity Musculoskeletal Diseases Neoplasms Neoplasms by Site

Age range

15 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Therapy

Behavioral

8 weeks personalized, multi-modal exercise with focus on lower extremity

Other names: physical activity intervention

Information

Other
  • Initial consultation with recommendations for general physical activity
  • Brochure with exercise recommendations.

Primary outcomes

  1. Gait Profile Score

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Functional Mobility

    Time frame: 8 weeks

    Functional Mobility Assessment score (points, score range 0 - 70, higher score = better outcome) between both study arms from T0 to T1

  2. Subjective functional outcome

    Time frame: 8 weeks

    Change in Musculoskeletal Tumor Society Score (questionnaire score, score range 0 - 30, higher score = better outcome) between both study arms

  3. Subjective functional measure

    Time frame: 8 weeks

    Change in Toronto Extremity Salvage Score(questionnaire score, score range 0 - 100, higher score = better outcome) between both study arms

  4. Subjective Quality of Life Adults

    Time frame: 8 weeks

    Change in Quality of Life (QLQ-C30 questionnaire score from 0 - 100) between both study arms

  5. Subjective Quality of Life Adolescents

    Time frame: 8 weeks

    Change in Quality of Life (PedsQL cancer module, questionnaire score from 0 - 100) between both study arms

  6. Fatigue Adults

    Time frame: 8 weeks

    Change in Fatigue (EORTC QLQ Fatigue questionnaire range 0 - 100, higher score = worse outcome) between both study arms

  7. Range of motion

    Time frame: 8 weeks

    Change in affected knee range of motion (angular degree °) assessed with goniometry between both study arms

  8. Gait kinematics

    Time frame: 8 weeks

    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.

  9. Fatigue Adolescents

    Time frame: 8 weeks

    Change in Fatigue (PedsQL fatigue questionnaire score, range 0 - 100, higher score = worse outcome)

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Collaborators

  • Ruhr University of Bochum

Registry information

Official study title

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

Acronym: proGAIT

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 15, 2021
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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