Randomized controlled trial to evaluate a 12-week app-guided exercise intervention in patients with knee osteoarthritis (re.flex)
- Conditions
- M17Gonarthrosis [arthrosis of knee]
- Registration Number
- DRKS00030932
- Lead Sponsor
- Sporlastic GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 195
Osteoathritis symptoms are primary located at the knee joint; moderate to severe knee osteoarthrititis diagnosis by a physician (KOOS <=60 where 100 indicates no complaints at all); good German language skills (Information sheet, questionnaires, app content); Willingness to use the app to exercise; access to a device with iOS or android operating system.
Scheduled elective knee joint replacement; already implanted artificial joint; osteoarthritis primarily in the hip joint or others than the knee; diffuse pain; 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 the exercise intervention itself; (digital) exercise interventions similar to the intervention under study or regular structured strengthening exercises for the lower extremities more than once a week during the past 6 months.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The two primary endpoints are the comparison of baseline-adjusted follow-up scores between intervention group and control group regarding osteoarthritis-specific pain (Knee Osteoarthritis Outcome Score, Subscale Pain) and physical function (Knee Osteoarthritis Outcome Score, Subscale Activities of daily living) directly after the 12-week intervention phase.
- Secondary Outcome Measures
Name Time Method Secondary endpoints include self-reporting on further health outcomes (e.g., health-related quality of life (VR12), fear of movement, other knee-related complaints (Knee Osteoarthritis Outcome Score, other subscales), Patient's Global Assessment). Objective measures consider leg strength and strength endurance testing (30-Second Chair Test). During the intervention, the perceived exertion during exercising, the exercise adherence as well as safety aspects during the intervention (pain, unexpected events or side effects) will be recorded. In addition, usability and patient satisfaction will be evaluated.