M16.9 M17.9
Conditions
Interventions
Group 1: 12 (twice per week, 1 h each) + 12 (optional, once per week, 1 h) weeks of a machine-based strength training program (mode of muscle action: concentric concentric)
Group 2: 12 (twice per week
Sponsors
AOK Baden-Württemberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Lifetime prevalence of hip and/or knee OA diagnosed by a medical practitioner Insurant of the insurance company offering the exercise program Physical and mental ability to participate in the interventional program
Exclusion criteria
Exclusion criteria: - Hypertension Stage 2-3: reread systolic blood pressure >160 prior maximum strength testing, reread diastolic blood pressure >100 prior maximum strength testing (Intervention group only) - Significant established osteoporosis requiring treatment, previous spontaneous or low impact fracture - Co-morbidities leading to major impairments in everyday life and representing contra-indications for physical activities - Artificial joint replacement at the knee and/or hip joint within the last 6 months - Surgery at the lower extremity within the last 3 months - Regular use of gait aids - Self-reported acute illness on t0 - Insufficient German language ability for self-administered questionnaires (IG) - Current employment in the health care insurance Exclusion criteria for primary data analysis only: - < 15 points on the WOMAC Index, subscale pain (0-100) and < 15 points on the WOMAC Index, subscale physical functioning In case of a previous artificial joint replacement at the hip and/or knee joint: - Acute joint inflammation - Instable anchoring of the artificial joint - Radiologic signs of implant loosening - Pain at rest or with activity due to artificial joint replacement at the knee and/or hip joint - Luxation as an adverse event of artificial hip replacement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Collection points: t0, t3 (number after t indicate month post baseline). - WOMAC Index 3.1 German (11-box NRS): subscale pain - WOMAC Index 3.1 German (11-box NRS): subscale physical functioning | — |
Secondary
| Measure | Time frame |
|---|---|
| Collection points: t0, t3, t6, t12, t24 (number after t indicate month post baseline). Clinical data: - WOMAC Index 3.1 German (11-box NRS): subscale pain (t6, t12, t24) - WOMAC Index 3.1 German (11-box NRS): subscale physical functioning (t6, t12, t24) - WOMAC Index 3.1 German (11-box NRS): subscale physical stiffness - WOMAC Index 3.1 German (11-box NRS): overall score - Health related quality of life: VR-12 incl. VR-6D utility index (4-week-time-slot) - Self-efficacy: General Self-Efficacy Scale (GSE) - Responder analysis: Omeract-OARSI Set of - Responder Criteria (composite score with minimum absolute and relative change levels for pain or pain & function) - Physical activity status: Habitual physical and sports activity status - Time to surgery Endpoint: “elective joint replacement” - Patient satisfaction: Modified version of the ZUF-8 Questionnaire - Maximum strength measures of hip and knee surrounding muscles and core (t0, t3, t6). Economic data: Cost categories: (1) intervention costs, (2) unspecific and (3) specific health care costs, (4) costs for days of disability) - Cost-Benefit Analysis (CBA) (intervention costs related to cost benefit of specific and unspecific health care costs and costs for days of disability) - Cost-Effectiveness Analysis (CEA) (overall costs related to health related effects via WOMAC-Index) - Cost-Utility Analysis (CUA) (overall costs related to quality adjusted life years (QALY) Adherence to exercise - Training log: Summarized number of attended training sessions Safety evaluation - Adverse events and side-effects: Summarized number and details of adverse events and side-effects | — |
Countries
Germany
Contacts
Public ContactGerhard Müller
AOK Baden-Württemberg
Outcome results
None listed