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Bone SarcomaPhase 2/3proGAITNCT04963517

Exercise Intervention for Bone Tumor Patients

A Phase 2/3 study testing Exercise therapy and Information in people with Bone Sarcoma, run by Universität Duisburg-Essen at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 to 45 years
Conditions the study is for
Bone Sarcoma
What is being tested?
Exercise therapy and Information
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteGermany
Study dates
7 Aug 2021to 1 May 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)

Who cannot join

  • <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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Essen

    Essen, North Rhine-Westphalia, 45147

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Conditions
Bone Sarcoma
Being tested
Exercise therapy, Information
Keywords
exercise, lower limb endoprosthesis, pediatric oncology, gait quality, 3D gait analysis
Medical subject headings
Bone Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise therapyBehavioural

    Also called physical activity intervention

    8 weeks personalized, multi-modal exercise with focus on lower extremity

  • InformationOther

    • Initial consultation with recommendations for general physical activity
    • Brochure with exercise recommendations.
Study groups in NCT04963517
Study groupRoleWhat they receive
Exercise therapyExperimental8 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
Receives: Behavioral: Exercise therapy
Information groupActive comparator* Initial consultation with recommendations for general physical activity * Brochure with exercise recommendations.
Receives: Other: Information

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 weeks

Secondary outcomes (9)

  1. Functional Mobility

    Functional Mobility Assessment score (points, score range 0 - 70, higher score = better outcome) between both study arms from T0 to T1

    Measured: 8 weeks

  2. Subjective functional outcome

    Change in Musculoskeletal Tumor Society Score (questionnaire score, score range 0 - 30, higher score = better outcome) between both study arms

    Measured: 8 weeks

  3. Subjective functional measure

    Change in Toronto Extremity Salvage Score(questionnaire score, score range 0 - 100, higher score = better outcome) between both study arms

    Measured: 8 weeks

  4. Subjective Quality of Life Adults

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

    Measured: 8 weeks

  5. Subjective Quality of Life Adolescents

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

    Measured: 8 weeks

  6. Fatigue Adults

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

    Measured: 8 weeks

  7. Range of motion

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

    Measured: 8 weeks

  8. 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.

    Measured: 8 weeks

  9. Fatigue Adolescents

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

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2021
  2. Study start7 Aug 2021
  3. Primary completion31 Dec 2021
  4. Study completion1 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04963517
Sponsor's protocol ID
proGAIT
Acronym
proGAIT
Status last verified
Dec 2024
First submitted
15 Jun 2021
Last updated
6 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Basteck S, Guder WK, Dirksen U, Krombholz A, Streitburger A, Reinhardt D, Gotte M. Effects of an Exercise Intervention on Gait Function in Young Survivors of Osteosarcoma with Megaendoprosthesis of the Lower Extremity-Results from the Pilot Randomized Controlled Trial proGAIT. Curr Oncol. 2022 Oct 14;29(10):7754-7767. doi: 10.3390/curroncol29100613.

    PubMed 36290890

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Exercise therapy and Information in people with Bone Sarcoma, run by Universität Duisburg-Essen at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait Profile Score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04963517, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

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