Trial document




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  DRKS00008735

Trial Description

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Title

Associations of physical activity levels with functional capacity in knee osteoarthritis patients during daily living

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Trial Acronym

KNEEMO

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URL of the Trial

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Brief Summary in Lay Language

It is known that, in general, people who suffer from knee osteoarthritis fail to be active enough and are too sedentary. However, it is unknown which activities generally are performed (or avoided) during daily living (for example running, cycling or stair climbing). During this study, we would therefore like to determine which activities the osteoarthritic population generally performs and avoids during daily living. Furthermore, we would like to test whether this population is able to perform specific movements, including walking without an aid and stair climbing. Such knowledge might give us more in-depth insight in the reasons behind the decreased activity levels in knee osteoarthritis patients.

Participants who suffer from knee osteoarthritis (according to the ACR guidelines) are allowed to participate in this study.They will first be asked to wear two activity monitors for one week. These activity monitors are small and unobtrusive; the participants will be able to perform their normal activities without any limits. One is worn around the ankle with a band and the other one is stuck on the upper leg. After this week, they will be required to come to our lab (Gait analysis lab, UKM), where some functional tests will be performed. These tests will require participants to stand up from a chair and climb stairs (± 10 steps) without aid.

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Brief Summary in Scientific Language

Previous studies have shown that knee osteoarthritis (KOA) patients often fail to meet activity guidelines and show sedentary behaviour for a substantial period per day. Yet, they have not been able to determine which activities are commonly performed (or avoided) in this population during daily living. Being less sedentary has been related to an improved physical function. Yet, we are unaware of a study that has actually examined physical function outside of a lab-based setting. Therefore, the aim of this study will be to objectively quantify time spent within pre-specified movement and activity classes from accelerometer monitoring and establish their relationship with lab-based physical functional and pain in clinical knee osteoarthritis patients.

An observational study will be performed, presenting an analysis of movement classes from one week of accelerometer monitoring in KOA patients. Examples of movement classes are: walking, running, cycling and stair ascending/descending. In addition, time spent within varying postures (sitting, standing and lying) will be examined. Participants will be required two wear two activity monitors simultaneously for one week: the Stepwatch Activity Monitor (SAM, pedometer) and the Heerlen Activity Monitor (HAM, triaxial accelerometer). Furthermore, several functional scores (The Timed Up and Go Test (TUGT) and a Stair Climb Test (SCT)) in combination with a questionnaire regarding pain and function (The Knee Osteoarthritis Outcome Score (KOOS)) will be examined.

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Organizational Data

  •   DRKS00008735
  •   2015/12/02
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  •   yes
  •   Approved
  •   2015-475-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   U1111-1174-7445 
  •   DRKS00009392  (DRKS00008735 + DRKS00009392 sind Teilstudien des KNEEMO-Forschungsprojektes/are substudies of the KNEEMO research project)
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Health Condition or Problem studied

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

  •   Patients with clinical knee osteoarthritis will be monitored for one week using the Stepwatch Activity Monitor and the Heerlen Activity Monitor. One is worn around the ankle with a band and the other one is stuck on the upper leg. Furthermore, they will be required to execute a Timed Up and Go Test, a Stair Climb Test and fill in the KOOS questionnaire to assess their physical function and pain during daily living
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The amount of steps (walking, running and stairclimbing), amount of repetitions (cycling) or time spent in different postures (standing or sitting/lying) will be measured with two different activity monitors during one week of monitoring.

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Secondary Outcome

Physical functioning will be measured by two functional tests: the TUGT and the SCT. The amount of time required to perform the test will be used as the outcome measure. In addition, physical function, pain and quality of life will be assessed by the KOOS. This will be a score from 0 to 100, where 0 represents the optimal score. These measurements will be performed in the movement lab.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/02/01
  •   52
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Eligible adults will be required to have clinical KOA according to the American College of Rheumatology guidelines, with knee pain ≥ 4 days per week for ≥3 months

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Exclusion Criteria

Exclusion criteria will be:
- Rheumatoid arthritis or any other form of inflammatory arthritis (e.g. crystal arthropathy)
- Diabetes
- Knee replacement, or a scheduled replacement surgery within 3 months in affected leg from or before the beginning of study participation.
- Medical conditions, which could interfere with the activity and test performance, such as neurologic conditions or severe cardiovascular disease.
- Use of ambulatory aid (single straight cane)

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Addresses

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    • Universitätsklinikum Münster
    • Mr.  Prof.  Dieter  Rosenbaum 
    • Albert-Schweitzer Campus 1, Gebäude D3
    • 48129  Münster
    • Germany
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    • Universitätsklinikum Münster
    • Mr.  M.Sc  Maik  Sliepen 
    • Albert-Schweitzer Campus 1, Gebäude D3
    • 48129  Münster
    • Germany
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    • Universitätsklinikum Münster
    • Mr.  M.Sc  Maik  Sliepen 
    • Albert-Schweitzer Campus 1, Gebäude D3
    • 48129  Münster
    • Germany
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Sources of Monetary or Material Support

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    • European CommissionMarie SkÅ‚odowska -Curie Innovative Training Networks
    • Unit REA-A1
    • B-1049  Brussels
    • Belgium
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Status

  •   Recruiting complete, follow-up complete
  •   2017/07/01
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Trial Publications, Results and other Documents

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