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Exercise Intervention for Bone Tumor Patients (proGAIT)

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ClinicalTrials.gov Identifier: NCT04963517
Recruitment Status : Recruiting
First Posted : July 15, 2021
Last Update Posted : August 30, 2021
Sponsor:
Collaborator:
Ruhr University of Bochum
Information provided by (Responsible Party):
Miriam Götte, Universität Duisburg-Essen

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.

Condition or disease Intervention/treatment Phase
Bone Sarcoma Behavioral: Exercise therapy Other: Information Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: 3D Gait Analysis to Determine Functional Limitations and Evaluate a Training Intervention in Young People With Tumor Endoprosthesis of the Lower Extremity
Actual Study Start Date : August 7, 2021
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise therapy

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
8 weeks personalized, multi-modal exercise with focus on lower extremity
Other Name: physical activity intervention

Active Comparator: Information group
  • Initial consultation with recommendations for general physical activity
  • Brochure with exercise recommendations.
Other: Information
  • Initial consultation with recommendations for general physical activity
  • Brochure with exercise recommendations.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04963517


Contacts
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Contact: Simon Basteck, B.Sc. +49 201 723 8083 simon.basteck@uk-essen.de
Contact: Miriam Götte, PhD +49 201 723 8083 miriam.goette@uk-essen.de

Locations
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Germany
University Hospital Essen Recruiting
Essen, NRW, Germany, 45147
Contact: Simon Basteck, M.Sc.    0049 201 7238083    simon.basteck@uk-essen.de   
Sponsors and Collaborators
Universität Duisburg-Essen
Ruhr University of Bochum
Investigators
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Principal Investigator: Miriam Götte, PhD University Hospital, Essen
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Responsible Party: Miriam Götte, Principal investigator, Head of exercise oncology group, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT04963517    
Other Study ID Numbers: proGAIT
First Posted: July 15, 2021    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Miriam Götte, Universität Duisburg-Essen:
exercise
lower limb endoprosthesis
pediatric oncology
gait quality
3D gait analysis
Additional relevant MeSH terms:
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Osteosarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue