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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03215602 |
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Date of registration:
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10/07/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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EXercise as TReatment for osteoArthritis
EXTRA |
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Scientific title:
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EXercise as TReatment for osteoArthritis |
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Date of first enrolment:
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July 18, 2017 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03215602 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Henrik M Schøder, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Naestved Hospital |
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Name:
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Mathias Wernbom, PT, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Göteborg University |
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Name:
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Pætur M Holm, PT, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Southern Denmark and Department of Physiotherapy and Occupational Therapy, Naestved-Slagelse-Ringsted Hospitals. |
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Name:
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Søren T Skou, PT, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Patients with symptomatic and radiographically confirmed knee-OA who are found not eligible
for knee replacement surgery by an orthopaedic surgeon in secondary health care.
Exclusion Criteria:
- Kellgren & Lawrence score of <2 on radiography
- Less than "mild" symptoms (mean score >75 in 0-100 KOOS-ADL)
- Medication: Morphine for pain other than knee-joint pain
- Previous ipsilateral knee arthroplasty
- Rheumatoid arthritis
- Inability to comply with the protocol
- Inadequacy in written and spoken Danish
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Knee Osteoarthritis
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Intervention(s)
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Other: NEMEX and education + strength training
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Other: NEMEX and education
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Primary Outcome(s)
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Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)
[Time Frame: Primary endpoint: Change from baseline to 12 weeks. Secondary endpoints: 6 weeks & 12 months.]
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Secondary Outcome(s)
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Pain medication
[Time Frame: Primary endpoint: Change from baseline to 12 weeks. Secondary endpoints: 6 weeks & 12 months.]
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Muscle power (watt/kg. bodyweight)
[Time Frame: Primary endpoint: Change from baseline to 12 weeks. Secondary endpoint: Baseline to 6 weeks.]
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Functional performance (40 m walk & stair-climbs)
[Time Frame: Primary endpoint: Change from baseline to 12 weeks. Secondary endpoint: 6 weeks.]
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AE (adverse events) & Serious Adverse Events (SAE)
[Time Frame: Primary endpoint: From baseline to 12 weeks.. Secondary endpoint: 12 months.]
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KOOS (remaining four subscales)
[Time Frame: Primary endpoint: Change from baseline to 12 weeks. Secondary endpoints: 6 weeks & 12 months.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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