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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

Tracking Information
First Submitted Date  ICMJE June 15, 2021
First Posted Date  ICMJE July 15, 2021
Last Update Posted Date August 30, 2021
Actual Study Start Date  ICMJE August 7, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2021)
  • 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
  • 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
  • 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
  • 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
  • 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
  • Fatigue Adults [ Time Frame: 8 weeks ]
    Change in Fatigue (EORTC QLQ Fatigue questionnaire range 0 - 100, higher score = worse outcome) between both study arms
  • Range of motion [ Time Frame: 8 weeks ]
    Change in affected knee range of motion (angular degree °) assessed with goniometry between both study arms
  • 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.
  • Fatigue Adolescents [ Time Frame: 8 weeks ]
    Change in Fatigue (PedsQL fatigue questionnaire score, range 0 - 100, higher score = worse outcome)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Intervention for Bone Tumor Patients
Official Title  ICMJE 3D Gait Analysis to Determine Functional Limitations and Evaluate a Training Intervention in Young People With Tumor Endoprosthesis of the Lower Extremity
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Condition  ICMJE Bone Sarcoma
Intervention  ICMJE
  • Behavioral: Exercise therapy
    8 weeks personalized, multi-modal exercise with focus on lower extremity
    Other Name: physical activity intervention
  • Other: Information
    • Initial consultation with recommendations for general physical activity
    • Brochure with exercise recommendations.
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Exercise therapy
  • Active Comparator: Information group
    • Initial consultation with recommendations for general physical activity
    • Brochure with exercise recommendations.
    Intervention: Other: Information
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 14, 2021)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04963517
Other Study ID Numbers  ICMJE proGAIT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Miriam Götte, Universität Duisburg-Essen
Study Sponsor  ICMJE Universität Duisburg-Essen
Collaborators  ICMJE Ruhr University of Bochum
Investigators  ICMJE
Principal Investigator: Miriam Götte, PhD University Hospital, Essen
PRS Account Universität Duisburg-Essen
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP