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Exercise Intervention for Bone Tumor Patients (proGAIT)

Primary Purpose

Bone Sarcoma

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Exercise therapy
Information
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bone Sarcoma focused on measuring exercise, lower limb endoprosthesis, pediatric oncology, gait quality, 3D gait analysis

Eligibility Criteria

15 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Essen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise therapy

Information group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Functional Mobility
Functional Mobility Assessment score (points, score range 0 - 70, higher score = better outcome) between both study arms from T0 to T1
Subjective functional outcome
Change in Musculoskeletal Tumor Society Score (questionnaire score, score range 0 - 30, higher score = better outcome) between both study arms
Subjective functional measure
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
Change in Quality of Life (QLQ-C30 questionnaire score from 0 - 100) between both study arms
Subjective Quality of Life Adolescents
Change in Quality of Life (PedsQL cancer module, questionnaire score from 0 - 100) between both study arms
Fatigue Adults
Change in Fatigue (EORTC QLQ Fatigue questionnaire range 0 - 100, higher score = worse outcome) between both study arms
Range of motion
Change in affected knee range of motion (angular degree °) assessed with goniometry between both study arms
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.
Fatigue Adolescents
Change in Fatigue (PedsQL fatigue questionnaire score, range 0 - 100, higher score = worse outcome)

Full Information

First Posted
June 15, 2021
Last Updated
November 14, 2022
Sponsor
Universität Duisburg-Essen
Collaborators
Ruhr University of Bochum
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1. Study Identification

Unique Protocol Identification Number
NCT04963517
Brief Title
Exercise Intervention for Bone Tumor Patients
Acronym
proGAIT
Official Title
3D Gait Analysis to Determine Functional Limitations and Evaluate a Training Intervention in Young People With Tumor Endoprosthesis of the Lower Extremity
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 7, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
Collaborators
Ruhr University of Bochum

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Sarcoma
Keywords
exercise, lower limb endoprosthesis, pediatric oncology, gait quality, 3D gait analysis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Information group
Arm Type
Active Comparator
Arm Description
Initial consultation with recommendations for general physical activity Brochure with exercise recommendations.
Intervention Type
Behavioral
Intervention Name(s)
Exercise therapy
Other Intervention Name(s)
physical activity intervention
Intervention Description
8 weeks personalized, multi-modal exercise with focus on lower extremity
Intervention Type
Other
Intervention Name(s)
Information
Intervention Description
Initial consultation with recommendations for general physical activity Brochure with exercise recommendations.
Primary Outcome Measure Information:
Title
Gait Profile Score
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Functional Mobility
Description
Functional Mobility Assessment score (points, score range 0 - 70, higher score = better outcome) between both study arms from T0 to T1
Time Frame
8 weeks
Title
Subjective functional outcome
Description
Change in Musculoskeletal Tumor Society Score (questionnaire score, score range 0 - 30, higher score = better outcome) between both study arms
Time Frame
8 weeks
Title
Subjective functional measure
Description
Change in Toronto Extremity Salvage Score(questionnaire score, score range 0 - 100, higher score = better outcome) between both study arms
Time Frame
8 weeks
Title
Subjective Quality of Life Adults
Description
Change in Quality of Life (QLQ-C30 questionnaire score from 0 - 100) between both study arms
Time Frame
8 weeks
Title
Subjective Quality of Life Adolescents
Description
Change in Quality of Life (PedsQL cancer module, questionnaire score from 0 - 100) between both study arms
Time Frame
8 weeks
Title
Fatigue Adults
Description
Change in Fatigue (EORTC QLQ Fatigue questionnaire range 0 - 100, higher score = worse outcome) between both study arms
Time Frame
8 weeks
Title
Range of motion
Description
Change in affected knee range of motion (angular degree °) assessed with goniometry between both study arms
Time Frame
8 weeks
Title
Gait kinematics
Description
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.
Time Frame
8 weeks
Title
Fatigue Adolescents
Description
Change in Fatigue (PedsQL fatigue questionnaire score, range 0 - 100, higher score = worse outcome)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam Götte, PhD
Organizational Affiliation
University Hospital, Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Essen
City
Essen
State/Province
NRW
ZIP/Postal Code
45147
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise Intervention for Bone Tumor Patients

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