Trial document




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  DRKS00009257

Trial Description

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Title

Effectiveness and efficiency of a supervised strength-machine based hip and knee training for patients with hip or knee osteoarthritis: A controlled study in the context of health service research.

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Trial Acronym

SM-HKT

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URL of the Trial

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Brief Summary in Lay Language

Osteoarthritis is the most common reason for pain in the elderly, and the individual and economic burden of this disease is immense. The chronic character of osteoarthritis requires a long-term therapeutic treatment. In this regard life-style interventions such as physical exercises that can be carried out by the patient himself are recommended as first line treatment. There is evidence for the short-term benefit of exercise therapy in terms of pain reduction and physical functioning.
For this reason the Health Insurance company AOK Baden-Württemberg offers a machine-based strength training program at two study sites (pilot sites) for insurance holders with hip and/or knee osteoarthritis. The machine-based hip and knee training comprises a 12-week training phase (2seesions/week) that can be prolonged for another 12 weeks (1/week). Strengthening exercises are supplemented by functional exercises. This training will now be evaluated in the context of a study. Insurance holders participating in the program will be compared to insurance holders who do not participate. The aim of this study is to investigate, whether the machine-based hip and knee training is - among other things - effective in terms of pain reduction and improvement of physical functioning and muscle strength. It further ask for the cost-utility of the program.
Aside from strength data, outcomes are quantified by way of questionnaires. Economic data are derived from the insurance data base. Participants of the study will be assessed at baseline and after 3 month and will further be followed up 6, 12 and 24 month after baseline.

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Brief Summary in Scientific Language

Background: Osteoarthritis is the most common reason for pain in the elderly, and the individual and economic burden of this disease is immense. The chronic character of osteoarthritis requires a long-term therapeutic treatment. In this regard life-style interventions such as physical exercises that can be carried out by the patient himself are recommended as first line treatment. There is evidence for the short-term benefit of exercise therapy in terms of pain reduction and physical functioning. Nonetheless knowledge on long-term effects, dose-response-relationships, mode of delivery, as well as it’s cost-utility and safety is limited and are therefore under the scope of this study.
Method: This is a quasi-experimental two-center controlled trial of a 12+12-week strength training program with an 18 months follow-up in the context of health care research. The study population consists of n = 600 subjects with hip or knee osteoarthritis. All participants are insurance holders of a large statutory health insurance company. The intervention group will be recruited from participants of a health insurance offer for people with hip or knee osteoarthritis. Patients of the intervention group (IG) are further quasi-randomized into a machine-based concentric strengthening program versus a combination of concentric and eccentric machine-based strengthening program according to their place of residence and therefore study center. Potential participants for the control group will be selected from the insurance data base according to pre-defined matching criteria and asked by letter for their participation.
The primary aim of this study is to determine whether a 12-week progressive machine-based strength training program decreases symptom related pain and increases physical function in subjects with hip and/or knee osteoarthritis in comparison to a matched control group in the short term. Effectiveness is quantified by the subscales pain and physical function of the WOMAC Index 3.1 NRS.
The secondary aims are to determine whether a 12-week progressive strength training program improves muscle strength (no control comparator), improves health-related quality of life and/or global rating of health, improves self-efficacy and physical activity levels, delays time to surgery, and is efficient with regard to personal and/or social costs.
Aside from strength measures all other secondary endpoints are compared to a matched pair control group. Secondary outcomes will be differentiated into a short-term perspective (12 week intervention), mid-term perspective (+12 week optional intervention) and a long-term perspective (follow-up data 12, 24 month after initiation of the intervention).
Secondary outcomes will further be differentiated into different intervention modes according to study site (mode of muscle contraction, type of strength machines, and number of exercises).
Discussion: Results of this trial will document the effects of clinical as well as economic outcomes in a regular health care setting. As such, results of this trial will have great validity for sounded recommendations with respect to machine-based strength training program for people with hip or knee osteoarthritis. It will further foster knowledge on different modes of delivery that are related to exercise dosage.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00009257
  •   2015/09/11
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  •   yes
  •   Approved
  •   421/2015BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   M16 -  Coxarthrosis [arthrosis of hip]
  •   M17 -  Gonarthrosis [arthrosis of knee]
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Interventions/Observational Groups

  •   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)
  •   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 eccentric)
  •   Matched Pairs Control. General Care
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment, Other
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2015/09/23
  •   600
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional 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

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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

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Addresses

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    • AOK Baden-Württemberg
    • Presselstr. 19
    • 70191  Stuttgart
    • Germany
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    • Medizinische Universitätsklinik Tübingen, Abteilung Sportmedizin
    • Hoppe-Seyler-Str. 6
    • 72076  Tübingen
    • Germany
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    • Medizinische Universitätsklinik Tübingen, Abteilung Sportmedizin
    • Ms.  Dr.  Inga  Krauß 
    • Hoppe-Seyler-Str. 6
    • 72076  Tübingen
    • Germany
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    • AOK Baden-Württemberg
    • Mr.  Dr.  Gerhard  Müller 
    • Bahnhofstraße 12-14
    • 76646  Bruchsal
    • Germany
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Sources of Monetary or Material Support

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    • AOK Baden-Württemberg
    • Presselstr. 19
    • 70191  Stuttgart
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/04/03
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Trial Publications, Results and other Documents

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