Preventing the progression of Osteoarthritis of the knee Grade 2- 3 by mechanical stimulation with high impact physical exercise training device (GALILEO)

Not Applicable

• Conditions: M17; Gonarthrosis [arthrosis of knee]

• Registration Number: DRKS00009677
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-26
• Results First Posted: 2018-07-18
• Study Completion: 2020-12-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Women and men in the age between 40 and 80 years
• OAK corresponding grad 2 and 3 according to Kellgren and Lawrence score
• pain > 40 mm measured with the 100 mm VAS over a minimum of 50 % of time within the last month
• Written inform consent

Exclusion Criteria

• Knee endoprosthesis at any time
• Hip endoprosthesis in the last12 months
• in the last five years: malignant diseases, angina pectoris, intervention of the coronary arteries, thromboembolic events (e.g. acute deep vein thrombosis, stroke, myocardial infarct, absolute arrhythmia, uncontrolled hypertension, occlusion of the retinal artery or –vein)
• Patients are not be able to perform the investigation conform to the protocol
• Patients with cognitive impairment excluding an understanding of the study protocol and /or the self-dependent completion of the questionnaires
• Insufficient understanding of the German language
• participation in an other clinical study at the same time
• existing pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
symptoms of OA measured by the WOMAC at baseline (month 0), month 6, month 12, month 18, month 24

Secondary Outcome Measures

Name	Time	Method
Frequency, duration and intensity of physical activity measured by means of accelerometers and self reports at M0 M12, M24;<br>Physical activity measured by Office in Motion Questionnaire (OIMQ) at M0, M6, M12, M18, M24;<br>Health-related quality of life measured by SF12-SOEP Version at M0, M6, M12, M18, M24;<br>Depressive symptoms measured by CES-D scale at M0, M6, M12, M18, M24;<br>Pain today measured by VAS at M0, M6, M12, M18, M24<br>