Exercise Intervention for Bone Tumor Patients

NCT04963517 | Completed Phase 2

• 1 other identifier: proGAIT
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Sarcoma

Keywords

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

Outcome Measures

Primary Outcomes (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.

  8 weeks

Secondary Outcomes (9)

• Functional Mobility

  8 weeks

• Subjective functional outcome

  8 weeks

• Subjective functional measure

  8 weeks

• Subjective Quality of Life Adults

  8 weeks

• Subjective Quality of Life Adolescents

  8 weeks

Study Arms (2)

Exercise therapy

EXPERIMENTAL

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

Information group

ACTIVE COMPARATOR

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

Other: Information

Interventions

Exercise therapy BEHAVIORAL

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

Also known as: physical activity intervention

Exercise therapy

Information OTHER

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

Information group

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• \<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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead
• Ruhr University of Bochum: collaborator

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Related Publications (1)

• 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.

  PMID: 36290890 BACKGROUND

MeSH Terms

Conditions

Bone Neoplasms; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Miriam Götte, PhD

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Head of exercise oncology group

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: July 15, 2021
• Study Start: August 7, 2021
• Primary Completion: December 31, 2021
• Study Completion: May 1, 2022
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)