Randomized controlled study in a wait-list control design to evaluate a 12-week app- and orthesis-supported training intervention in patients with moderate to severe knee osteoarthritis
- Conditions
- M17Gonarthrosis [arthrosis of knee]
- Registration Number
- DRKS00023269
- Lead Sponsor
- niversitätsklinikum Tübingen Abt. Sportmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 61
Osteoathritis symptoms are primary located at the knee joint; unicondylar knee osteoarthritis; moderate to severe knee osteoarthrititis (KOOS <=60 where 100 indicates no complaints at all); good German language skills (Information sheet, questionnaires); Willingness to wear the orthosis while exercising, Willingness to use the app to exercise, access to a device with iOS operating system.
Scheduled elective knee joint replacement; already implanted artificial joint; osteoarthritis primarily in the hip joint or others than the knee; diffuse pain; solely retropatellar knee osteoarthritis; Complaints that affect physical performance in everyday life, measured by use of the PAR-Q, verified by the physician, if applicable; Complaints located at the back or lower extremities that are currently treated by a medical doctor or health professional; previous surgeries, injuries or complaints that may impair measures of strength and balance or the exercise intervention itself.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the joint comparison of the two App study arms with regard to osteoarthritis-specific symptoms (Knee Osteoarthritis Outcome Score) in contrast to the waiting list control group immediately before and after the 12-week intervention phase.
- Secondary Outcome Measures
Name Time Method Other study endpoints include self-reporting on health-related quality of life (VR12), fear of movement (Brief Tampa Skale of Kinesiophobia) and sports and physical activity (EHIS-PA). Objective measures include maximum force measurement for knee flexors/extensors, testing of leg strength and strength endurance (30-second chair test), and balance tests (course of the centre of pressure (COP) during bipedal, one-legged and tandem stands). During the intervention, the sensation of exertion during training, the quality and quantity of exercise performance, training adherence, and the recording of safety aspects during the intervention (pain, unexpected events or side effects) are also recorded.<br>The evaluation also takes into account a differentiation into app versus app and orthosis as well as the analysis of follow-up time points 24 weeks after baseline. <br>