Exercise Intervention for Bone Tumor Patients (proGAIT)

Universität Duisburg-Essen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Bone Sarcoma

Treatments: Other: Information; Behavioral: Exercise therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04963517

proGAIT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 15 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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11 participants in 2 patient groups

Exercise therapy

Experimental group

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

Treatment:

Behavioral: Exercise therapy

Information group

Active Comparator group

Description:

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

Treatment:

Other: Information