Abstract
INTRODUCTION: Osteoarthritis is a chronic musculoskeletal disease with a major impact on the individual and the healthcare system. As there is no cure, therapy aims for symptom release and reduction of disease progression. Physical exercises have been defined as a core treatment for osteoarthritis. However, research questions related to dose response, sustainability of effects, economic efficiency and safety are still open and will be evaluated in this trial, investigating a progressive weight machine-based strength training. METHODS AND ANALYSIS: This is a quasi-experimental controlled trial in the context of health services research. The intervention group (n=300) is recruited from participants of an offer for insurants of a health insurance company suffering from hip or knee osteoarthritis. Potential participants of the control group are selected and written to from the insurance database according to predefined matching criteria. The final statistical twins from the control responders will be determined via propensity score matching (n=300). The training intervention comprises 24 supervised mandatory sessions (2/week) and another 12 facultative sessions (1/week). Exercises include resistance training for the lower extremity and core muscles by use of weight machines and small training devices. The training offer is available at two sites. They differ with respect to the weight machines in use resulting in different dosage parameters. Primary outcomes are self-reported pain and function immediately after the 12-week intervention period. Health-related quality of life, self-efficacy, cost utility and safety will be evaluated as secondary outcomes. Secondary analysis will be undertaken with two strata related to study site. Participants will be followed up 6, 12 and 24 months after baseline. TRIAL REGISTRATION NUMBER: German Clinical Trial Register DRKS00009257. Pre-results.