Feasibility and preliminary effects on mobility-related Outcomes of a combined supervised and home-based whole body Vibration Intervention after inpatient medical treatment for childhood cancer

Not Applicable

• Conditions: C00-D48; Neoplasms

• Registration Number: DRKS00014713
• Lead Sponsor: Deutsche Sporthochschule Köln, Institut für Kreislaufforschugn und Sportmedizin, Abteilung Molekulare und Zelluläre Sportmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-15
• Study Completion: 2019-04-30
• Results First Posted: 2021-05-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Completion of inpatient care for pediatric cancer within the last five years
• Medical treatment for pediatric cancer included chemotherapy
• Age between 6 and 21 years
• Medical clearance of the treating physician prior to study participation
• Written informed consent from the legal guardian and a child-specific informed assent from the participant prior to study participant

Exclusion Criteria

• Other diseases that go along with peripheral neuropaty/neuromuscular disorders
• Amputations or other strong functional impairments of the lower limb
• Palliative care
• Specific conditions that would prevent participation in WBV-training or testing (following the physician’s advice)
• exclusion criteria according to the suggestions of the device manufacturer

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional mobility (Timed-up-and-Go-Test): t0 (baseline), t1 (after 12 weeks), t2 (after 24 weeks)

Secondary Outcome Measures

Name	Time	Method
• Balance (one-leg stand)<br>• walking capacity (2-minute walk test)<br>• walking speed (10-meter walk test)<br>• functional mobility (Timed-Up-And-Go-Test)<br>• symptoms of chemotherapy-induced peripheral neuropathy (ped mTNS)<br>• ankle dorsiflexion range of motion (goniometer)<br>• strength of knee extensors and ankle dorsiflexors (hand-held dynamometer)<br>• physical activity (accelerometer Aktigraph)<br>• muscle fatigue (NIRS)<br>• Satisfaction with the training program (questionnaire/safety (documentation of adverse Events)/ attendance/ WBV-related side-effects/ adherence to the vibration protocol<br><br> time of testing: t0 (baseline), t1 (after 12 weeks), t2 (after 24 weeks)