Trial document




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  DRKS00018847

Trial Description

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Title

Feasibility and effectiveness of an individualized, group-based physical exercise program with educational components in people with knee and/or hip OA – a randomized controlled pilot study

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Trial Acronym

TREAT ME

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URL of the Trial

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Brief Summary in Lay Language

Arthrosis is considered as the most common disease of the joints in adults worldwide (Robert Koch Institute, 2015). International studies show that neuromuscular exercise programs in combination with education represent an effective therapy for knee and hip osteoarthrosis. Therefore, the present study investigates the feasibility and effectiveness of an individualized exercise program based on the NEMEX (Neuromuscular exercise) program with educational components. The feasibility of the chosen methodological approach of the study as well as the feasibility of the program including the acceptability by persons with knee and/or hip osteoarthritis are operationalized according to published recommendations (Thabane et al., 2010; Eldridge et al., 2016) on the basis of predefined criteria in the domains of study design including randomization, measurement instruments, costs, intervention, assessment of effects of the intervention and effort. The training program aims to improve physical mobility, osteoarthrosis-related complaints, the functional interaction of strength, flexibility and proprioception, range of motion in the hip and knee, strength in the lower extremities and the occupational performance. A further goal of the program is to improve coping strategies for pain, as well as the understanding and evaluation of pain. To assess these outcomes, appropriate measurement instruments are used at defined time points.

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Brief Summary in Scientific Language

This longitudinal study is a two-armed, randomised, controlled pilot-study. Its primary aim is to analyse the feasibility of an individualized, group-based physical exercise program in combination with educational components in people with hip and/or knee osteoarthrosis within the context of care in the university outpatient clinic (“Interprofessionelles Gesundheitszentrum”, InGe) of the University of Applied Health Sciences (Hochschule für Gesundheit) in Bochum.
A further aim within the scope of the study is to preliminarily assess possible intervention effects on complaints caused by hip and/or knee osteoarthrosis, the subjective functional level in activities of daily living, functional parameters (mobility, range of motion/control, strength) and psychological parameters.

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Organizational Data

  •   DRKS00018847
  •   2019/11/18
  •   [---]*
  •   yes
  •   Approved
  •   2019-09, Ethikkommission an der Physio-Akademie des Deutschen Verbands für Physiotherapie, Wremen
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Secondary IDs

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Health Condition or Problem studied

  •   M15 -  Polyarthrosis
  •   M16 -  Coxarthrosis [arthrosis of hip]
  •   M17 -  Gonarthrosis [arthrosis of knee]
  •   Persons with hip and/or knee (osteo)arthrosis, which has been diagnosed by a physician. In addition, the criteria of the “American College of Rheumatology” for an idiopathic arthrosis of the hip joint (Altman et al., 1991) or an arthrosis of the knee joint (Altman et al., 1986) should be fulfilled.
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Interventions/Observational Groups

  •   Participants of the intervention group receive usual care plus an individualized, group-based exercise program combined with an educational part over a period of six weeks.

    In Germany, usual care consists of the covered care by the statutory health insurance companies.
    Currently, this can be either a prescription of 20 minutes of physiotherapy at one to two appointments per week, typically over a period of three to nine weeks, a participation in a rehabilitation group or no therapy at all.

    The individualized, group-based intervention program takes place on two days per week for about one hour. Additionally, the educational part is carried out on three dates for about 45 minutes. The groups consist of a maximum of six participants and are led by certified physiotherapists and/or occupational therapists.
  •   Participants of the control group receive usual care as described above (Arm 1, "intervention group"), but no additional interventions.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Feasibility: The feasibility of the chosen methodological approach in the study as well as the feasibility including the acceptability by persons with hip and/or knee osteoarthrosis are operationalized according to published recommendations (Thabane et al., 2010; Eldridge et al., 2016) on the basis of predefined criteria in the domains of study design including randomization, measurement instruments, costs, intervention, assessment of effects of the intervention and effort.

Effectiveness: Complaints caused by hip and/or knee osteoarthrosis are assessed by standardized questionnaires “Hip Osteoarthritis Outcome Score“ (HOOS) (Blasimann, Dauphinee, & Staal, 2014) and „Knee Injury and Osteoarthritis Outcome Score“ (KOOS) (Collins, Misra, Felson, Crossley, & Roos, 2011; Kessler, Lang, Puhl, & Stöve, 2003) before and after the intervention period within three weeks.

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Secondary Outcome

Effectiveness: Secondary outcome measures are also assessed before and after the intervention period within three weeks.

[1] Mobility, assessed with the six-minute walk test (Ateef, Kulandaivelan, & Tahseen, 2016; Dobson et al., 2017; Enright, 2003).

[2] Range of motion of hip and knee, assessed with a goniometer using the neutral-0-method (Ryf & Weymann, 1999).

[3] Strength, assessed with a force dynamometer (Muff, G. et al., 2016; Awward et al., 2017).

[4] Physical performance: functional interaction of strength, flexibility and proprioception (in individual cases), assessed with the Y Balance Test (Coughlan et al., 2012; Plisky et al., 2009).

[5] Occupational performance, assessed with the Canadian Occupational Performance Measure (COPM) (Law, 2015).

[6] Measuring coping strategies for pain and its evaluation, assessed with the Pain Catastrophizing Scale, German version (Meyer, Sprott, & Mannion, 2008; Verra & Winteler, 2015).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2019/10/28
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   38   Years
  •   no maximum age
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Additional Inclusion Criteria

• Persons who suffer from knee and/or hip osteoarthrosis
• Hip osteoarthrosis 50 years
• Knee osteoarthrosis 38 years
• Arthrosis diagnosed by a physician (following ICD-10: M15 – Primary generalized (osteo)arthrosis, M16 – Coxarthrosis [arthrosis of hip] and/or M17 – Gonarthrosis [arthrosis of knee]
• Fulfilment of the criteria of the “American College of Rheumatology” (ACR) for an idiopathic arthrosis of the knee joint (Altmann et al., 1986) or the hip joint (Altman et al., 1991)

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Exclusion Criteria

• In case of uncertainties regarding the suitability for physical training and without medical consent regarding the suitability for physical training.
• Persons who participate in a systematic physical training of more than two hours per week with the aim of decreasing osteoarthrosis-related symptoms.
• Patients who are on a waiting list for the implantation of a total endoprosthesis (TEP), who already have a fixed appointment for this or whose affected joint has already been replaced by a TEP.

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Addresses

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    • Hochschule für Gesundheit, Bochum
    • Mr.  Prof. Dr.  Christian  Grüneberg 
    • Gesundheitscampus 6-8
    • 44801  Bochum
    • Germany
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    • Hochschule für Gesundheit, Bochum
    • Mr.  Prof. Dr. phil. habil.  Christian  Thiel 
    • Gesundheitscampus 6-8
    • 44801  Bochum
    • Germany
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    • Hochschule für Gesundheit, Bochum
    • Ms.  M.Sc.  Franziska  Weber 
    • Gesundheitscampus 6-8
    • 44801  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Hochschule für Gesundheit, Bochum
    • Gesundheitscampus 6-8
    • 44801  Bochum
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.