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Exercise Intervention for Bone Tumor Patients

NCT ID: NCT04963517

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-07

Study Completion Date

2022-05-01

Brief Summary

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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

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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

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Bone Sarcoma

Keywords

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exercise lower limb endoprosthesis pediatric oncology gait quality 3D gait analysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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

Group Type EXPERIMENTAL

Exercise therapy

Intervention Type BEHAVIORAL

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

Information group

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

Group Type ACTIVE_COMPARATOR

Information

Intervention Type OTHER

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

Interventions

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Exercise therapy

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

Intervention Type BEHAVIORAL

Information

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

Intervention Type OTHER

Other Intervention Names

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physical activity intervention

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role collaborator

Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

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Miriam Götte

Principal investigator, Head of exercise oncology group

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miriam Götte, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Essen

Locations

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University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 36290890 (View on PubMed)

Other Identifiers

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proGAIT

Identifier Type: -

Identifier Source: org_study_id