Trial document





This trial has been registered retrospectively.
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  DRKS00012682

Trial Description

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Title

Impact of a tailored activity counselling intervention during inpatient rehabilitation after knee and hip arthroplasty

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Trial Acronym

Reha-OL

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URL of the Trial

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Brief Summary in Lay Language

The purpose of the study is to analyse if an additional promotion of physical activity, such as daily steps, during inpatient rehabilitation, leads to a longer lasting increase of the physical activity up to six months after rehabilitation. Recent studies indicated that the physical activity of patients after receiving their first knee or hip arthroplasty is lower compared to healthy people. Thus, the physical activity is addressed during inpatient rehabilitation with a step counter, measuring the daily steps taken. The data is discussed twice a week with the patients, and the aim is to increase the daily steps by 5% twice a week. Patients are included when 45 years or older, receiving their first knee or hip joint due to osteoarthritis. One group of patients receives the step counter (intervention group), a second group does not (control group). It is analysed if the patients of the intervention group is more active three and six months after inpatient rehabilitation compared to the control group.

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Brief Summary in Scientific Language

Own research demonstrates that physical activity after primary knee or hip joint replacement is lower compared to healthy peers, and increased very slowly after end of treatment (Brandes et al., 2011). Comorbidities further decelerate the restoration of physical activity (Harding et al., 2013; Peiris et al., 2013; Tsonga et al., 2011). Hence, four years after surgery patients walk considerably less than healthy peers (Vissers et al., 2013).
Recently, step counting has proven to be a suitable intervention to increase daily physical activity in various settings. In particular, adaptive approaches such as increasing physical activity by 10%, thus taking the current daily activity into account, seem to be promosing instead of using rigid recommendation, such as walking 10.000 steps/day, and were sucessfully implemented for weight reduction (Adams et al., 2013) and cardiologic rehabilitation (Kaminsky et al., 2013). However, a direct transfer of previous findings is not applicable due to the relatively small duration of inpatient rehabilitation of knee/hip joint athroplasty patients, which is three weeks in Germany.

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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

  •   DRKS00012682
  •   2017/08/04
  •   [---]*
  •   yes
  •   Approved
  •   11/2014, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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Secondary IDs

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

  •   Z96.64 -  [generalization Z96.6: Presence of orthopaedic joint implants]
  •   Z96.65 -  [generalization Z96.6: Presence of orthopaedic joint implants]
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Interventions/Observational Groups

  •   Control group.
    The controls received the standard rehabilitation procedures only, such as strength training, aqua therapy, courses with respect to activities of daily life.
  •   Intervention group.
    The intervention group received the standard procedures of the rehabilitation (see control group) and, additionally, a step counter for the time of the inpatient rehabilitation. The step counter was read out twice a week by an employee of the rehabilitation centre. The data was visualized to the patient by a plot steps by minute for every day. Periods of continuous walking were identified. Subsequently, the patient was encouraged to increase the activity by 5% until the next meeting with the employee. No rewards for reaching the goal as well as no penalties for not meeting the goal were provided.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Average number of steps per day, measured over a period of seven days, six months after finishing inpatient rehabilitation. Daily steps were measured by the Step Activity Monitor 3.0 (Orthocare Innovations, USA).

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Secondary Outcome

Clinical outcome: Oxford knee/hip score
Quality of life: SF-36. Measured six months after finishing the inpatient rehabilitation.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/07/01
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Primary, unilateral knee or hip arthroplasty, due to osteoarthritis

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Exclusion Criteria

contralateral arthroplasty, contralateral end-stage osteoarthritis, secondary arthroplasty

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Addresses

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    • Leibniz-Institut für Präventionsforschung und Epidemiologie - BIPS
    • Mr.  PD Dr.  Mirko  Brandes 
    • Achterstraße 30
    • 28359  Bremen
    • Germany
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    • Leibniz-Institut für Präventionsforschung und Epidemiologie - BIPS
    • Mr.  PD Dr.  Mirko  Brandes 
    • Achterstraße 30
    • 28359  Bremen
    • Germany
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    • Leibniz-Institut für Präventionsforschung und Epidemiologie - BIPS
    • Mr.  PD Dr.  Mirko  Brandes 
    • Achterstraße 30
    • 28359  Bremen
    • Germany
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Sources of Monetary or Material Support

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    • Leibniz-Institut für Präventionsforschung und Epidemiologie - BIPS
    • Mr.  PD Dr.  Mirko  Brandes 
    • Achterstraße 30
    • 28359  Bremen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/07/15
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Trial Publications, Results and other Documents

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