Exercise Intervention for Bone Tumor Patients (proGAIT)

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Sarcoma
• Intervention / Treatment: Behavioral: Exercise therapy; Other: Information

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: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45147
      • University Hospital Essen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Mobility	Functional Mobility Assessment score (points, score range 0 - 70, higher score = better outcome) between both study arms from T0 to T1	8 weeks
Subjective functional outcome	Change in Musculoskeletal Tumor Society Score (questionnaire score, score range 0 - 30, higher score = better outcome) between both study arms	8 weeks
Subjective functional measure	Change in Toronto Extremity Salvage Score(questionnaire score, score range 0 - 100, higher score = better outcome) between both study arms	8 weeks
Subjective Quality of Life Adults	Change in Quality of Life (QLQ-C30 questionnaire score from 0 - 100) between both study arms	8 weeks
Subjective Quality of Life Adolescents	Change in Quality of Life (PedsQL cancer module, questionnaire score from 0 - 100) between both study arms	8 weeks
Fatigue Adults	Change in Fatigue (EORTC QLQ Fatigue questionnaire range 0 - 100, higher score = worse outcome) between both study arms	8 weeks
Range of motion	Change in affected knee range of motion (angular degree °) assessed with goniometry between both study arms	8 weeks
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.	8 weeks
Fatigue Adolescents	Change in Fatigue (PedsQL fatigue questionnaire score, range 0 - 100, higher score = worse outcome)	8 weeks

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Collaborators: Ruhr University of Bochum
• Investigators: Principal Investigator: Miriam Götte, Phd, University Hospital, Essen

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: exercise; lower limb endoprosthesis; pediatric oncology; gait quality; 3D gait analysis
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Sarcoma; Osteosarcoma
• Other Study ID Numbers: proGAIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No