proGAIT: Exercise Intervention for Bone Tumor Patients

• Sponsor: Universität Duisburg-Essen (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04963517
• Collaborator: Ruhr University of Bochum (Other)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6.8
• Patients Per Site Per Month: 3

Study Details

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.

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Aug 7, 2021
• Actual Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Gait Profile Score [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 [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 [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 [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 [8 weeks]

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

5. Subjective Quality of Life Adolescents [8 weeks]

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

6. Fatigue Adults [8 weeks]

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

7. Range of motion [8 weeks]

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

8. Gait kinematics [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 [8 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Essen	Essen	NRW	Germany	45147

Sponsors and Collaborators

• Universität Duisburg-Essen
• Ruhr University of Bochum

Investigators

• Principal Investigator: Miriam Götte, PhD, University Hospital, Essen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Jul 15, 2021
• Last Update Posted: Feb 11, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Miriam Götte, Principal investigator, Head of exercise oncology group, Universität Duisburg-Essen: exercise; lower limb endoprosthesis; pediatric oncology; gait quality; 3D gait analysis
• Additional relevant MeSH terms: Osteosarcoma

Study Results

No Results Posted as of Feb 11, 2022