M16
Conditions
Interventions
Group 1: Exercise therapy: Intervention period 12 weeks between M1 and M2.
Number of subject in treatment arm 1: n=70.
Contents of intervention: "Hipschool” comprises group therapy once a week (60-90’
Sponsors
Medizinische Universitätsklinik Tübingen, Abteilung Sportmedizin
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: • Age 18 – 85 years • Hip OA in one or both hip joints according to the clinical classification of the American College of Rheumatology • Informed consent of the subject • Sufficient time to keep therapeutic appointements • Health related eligibility in terms of physical and emotional ability. • Capacity to consent • Subjects can also be included in case of a contra-lateral hip replacement, as long as one side has a hip osteoarthritis according to the above mentioned criteria
Exclusion criteria
Exclusion criteria: • Instable anchoring of a potential artificial hip replacement • Previous luxation as an adverse event in case of an artificial hip replacement • Pathologies in the region of the lower extremities or lower back that are not related to OA and need medical treatment (healthy practitioners of medical doctors) • Abuse of drugs or alcohol • Participation in another clinical trial in the last 4 weeks • No Compliance • Acute illness • Use of walking-aids • Previous trauma at the hip or pelvis with subsequent development of a secondary arthrosis • Known endocrinologic cause of hip OA • Verified metabolic cause of hip OA • State after aseptic osteonecrose • Cardio-vascular disease or other co-morbidities resulting in a profoundly decreased physical capacity in every day live and known as contraindication for physical activities (i. e. cardiac insufficiency NYHA III-IV, terminal renal insufficiency state IV). • Medical exercise therapy, and physiotherapy using weight machines and comparable resources in the last three month, being carried out at least 6 times. • Specific group or individual intervention to address OA in the last 3 month (Minimum 1x/week 30‘ or more) • Physical therapy to address OA (Minimum 1x/week) • Novel initiated physical exercise within the last 3 month (Minimum 1x/week to be short of breath for at least 30’) • Corticoid injection into the hip joint within the last 12 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subscale Pain SF36. M2 versus M1. Comparison of Hipschool versus no intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| M1 +M2 + M3 + M4: The 36-item Short Form (SF36) is a well-established generic health status measure. It comprises different scales, four of them related to physical health (physical functioning, role-physical, bodily pain, general health), and four of them related to mental health (vitality, social functioning, role-emotional, mental health). Another question is related to the actual health status. All scales and sum scores will be analysed as secondary outcomes at each measurement day M1-M4 (apart from bodily pain M2 versus M1 as being the primary outcome criteria). M1 +M2 + M3 + M4: The Western Ontario McMasters Universities Osteoarthritis Index (WOMAC® NRS German for Germany 3.1 Index) is a disease specific instrument used to evaluate self-reported pain, stiffness and functional impairment. All scales and sum scores will be analysed as secondary outcomes at each measurement day M1-M4. M2 + M3: A five point Likert Scale will be used on M2 and M3 to quantify satisfaction with the therapy regime, and whether participants would recommend this therapy to others. Monthly logbooks between M1 and M2, and at M3 and M4 (M3 and M4 in the context of the telephone interview): Participants are asked to fill out a monthly logbook between M1 and M2. They have to specify previous physiotherapy and/or exercise, medication, and pain (retrospective time frame of four weeks, or to the last measurement day (M2 for M3, M3 for M4)). M1 + M2: Postural control will be quantified in bi-pedaled, tandem-, and single leg stance on a measuring system for force distribution (FDM System, zebris Medical GmbH, Isny, Germany). The outcome measure for postural control is the total path of the centre of force over the entire trial. M1 + M2: Participants will undergo three-dimensional gait analysis in barefoot and shod condition at self-selected normal speed. Kinematic and spatial-temporal data will be collected using a Vicon motion analysis system with six cameras (ViconPeak, MCAM M1, 120 Hz | — |
Countries
Germany
Contacts
Public ContactInga Krauß
Medizinische Universitätsklinik, Abteilung Sportmedizin
Outcome results
None listed