Trial document




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  DRKS00004822

Trial Description

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Title

Life in motion

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The rehabilitation strategy “Life in motion” supports patients after hip or knee joint replacement in planning and starting physical exercise. Action planning is realised in a one-to-one session. If possible, a contact to a local sport group is established. Moreover, an educational measure is added to the rehabilitation program to explain the importance of physical activity.
Efficacy of the modified program is examined by a study that compares the results of the conventional rehabilitation program with the modified rehabilitation program. We expect that patients who participate in the modified rehabilitation program will be physically more active, will have fewer functional limitations and better general health after one and nine months.

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Brief Summary in Scientific Language

The rehabilitation strategy “Life in motion” supports patients after hip or knee arthroplasty in planning and starting physical exercise. Action planning is realised in a one-to-one session and includes, if possible, the contact with a local fitness centre, a local sport group or other community-based services in the patient’s neighbourhood that offer opportunities to perform physical exercise. Furthermore, an educational module is added to the usual rehabilitation program that teaches the importance of physical activity for patients with hip or knee arthroplasty. This educational measure shall improve the patient’s outcome expectancies and support the patient’s intentions to start physical activity. These additional measures are based on Schwarzer’s Health Action Process Approach.
The efficacy of the modified rehabilitation program will be examined in a non-randomised controlled trial. We hypothesise that patients who are treated in the intervention group will be physically more active (primary outcome), will have fewer functional limitations and better general health (secondary outcomes). Follow-up measurements are assessed after one and nine months. Controls attain rehabilitation as usual and are recruited before implementation of the new rehabilitation strategy.

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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

  •   DRKS00004822
  •   2013/04/15
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  •   yes
  •   Approved
  •   1732-2013, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  •   U1111-1136-7908 
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Health Condition or Problem studied

  •   Z96.6 -  Presence of orthopaedic joint implants
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Interventions/Observational Groups

  •   Inpatient orthopaedic rehabilitation that includes an educational measure explaining the relevance to be physically active and a one-to-one session in order to individually plan physical exercise; if possible, this includes contacting a sport group in the patient’s neighbourhood
  •   Inpatient orthopaedic rehabilitation
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome is the amount of moderate and strenuous physical exercise during a typical week of the last month in minutes per week as measured by a modified version of the Godin Leisure Time Exercise Questionnaire.
The baseline score is assessed in the study cente at the beginning of rehabilitation. Follow-up measurements are assessed by postal questionnaires after one and nine months .

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Secondary Outcome

Limitations of physical functions: Functional complaints are assessed with the short version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The short form covers pain (five items) and function (eight items). The single items with values from 0 to 4 are summed. Sum scores are then transformed into values ranging from 0 to 100. Higher values represent a greater impairment.

General health status: The general health status is assessed with five items from the Short Form Health Survey (SF-36). The items are summarised to a total score with values ranging from 0 to 100. Higher values represent a better health status.

Depression: Depressive mood is measured by the 2-item depression scale of the Patient Health Questionnaire (PHQ-2). The items assess the frequency (0= “not at all” to 3 = “nearly every day”) of two depressive core symptoms (little interest or pleasure in doing things and feeling down, depressed, or hopeless). The total score ranges from 0 to 6 points.

Outcome expectancies: Positive outcome expectancies are assessed with five 4-point items (1= “not at all true” to 4= “exactly true”), e.g. “When I am regularly physically active, I am doing something good for my health.”

Self-Efficacy: Self-efficacy of performing physical activity is assessed with five 4-point items (1 = “not at all true” to 4 = “exactly true”), e.g. “I am certain, that I will be physically active, even though I have other concerns."

Intention of physical activity: For the measurement of intentions of physical activity, we use three items, e.g. “I intend to do more sports”. The response format for the items has 4 levels (1 = “not at all true” to 4 = “exactly true”).

Action planning: The planning of physical activity is measured by three 4-point items (1 = “not at all true” to 4 = “exactly true”), which assess which, where and when and how often physical activity is planned, e.g. “I have already planned in detail, where I will be physically active.”

Action control: Action control is assessed by three 4-point items (1 = “not at all true” to 4 = “exactly true”). The items measure self-monitoring, awareness of standards and self-regulation effort, e.g. “I have always sought to be as physically active as I have made up my mind.”

Social support: Social support to perform physical activity is measured by two 4-item scales. One assesses the support of family members and friends, the other one the support of other people (e.g. fitness trainer or sport group leaders). The response format of the items has 4 levels (1 = “not at all true” to 4 = “exactly true”).

Stages Assessment: The stage of behavioural change is assessed by a single 5-point item: “Have you been physically active on two or more days per week in the last three month?” The response categories “No, and I do not intend to start” as well as “No, but I am considering it” describe preintenders. The answer category “No, but I seriously intend to start” describes intenders. The answer categories “Yes, but it was very difficult” and “Yes, and it was very easy for me” characterise people who are already active.

Benefits of social insurance agencies: To assess benefits of social insurance agencies, we asked persons about disability pensions. Additionally, working people were asked about sickness benefits. Moreover, patients were asked about, the needed level of care.

Covariates: Assessment of additional covariates follows the recommendations for socio-demographic basic data in rehabilitation research. To assess comorbidity, the German version of the Self-Administered Comorbidity Questionnaire (SCQ) is used.

Measurement timepoints: Baseline measures are assessed in the study cente at the beginning of rehabilitation. Follow-up measurements are assessed by postal questionnaires after one and nine months.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/08/19
  •   260
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   60   Years
  •   85   Years
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Additional Inclusion Criteria

Persons with need for rehabilitation after hip or knee joint replacement (Z96.6) following coxarthrosis (M16) or gonarthrosis (M17)

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Exclusion Criteria

none

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Addresses

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    • Medizinische Hochschule HannoverKlinik für Rehabilitationsmedizin
    • Mr.  Prof. Dr. med.  Christoph  Gutenbrunner 
    • Carl-Neuberg-Straße 1
    • 30625   Hannover
    • Germany
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    • Medizinische Hochschule Hannover Klinik für Rehabilitationsmedizin
    • Ms.  Dr.  Annika  Gottschling-Lang 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover Klinik für Rehabilitationsmedizin
    • Ms.  Dr.  Annika  Gottschling-Lang 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Erwin-Röver-Stiftung
    • Adelheidstraße 4-5
    • 30171  Hannover
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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