- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03125954
Changes in Physical Inactivity in Patients with Knee Osteoarthritis
Changes in Physical Inactivity Secondary to Exercise Therapy in Patients with Knee Osteoarthritis: a Prospective Cohort Study
This is an objective cohort study using objective recording of physical activity (accelerometry) during and after the GLAiD intervention to investigate if a sedentary behavior change by participating in an 6-week physiotherapy-led exercise and education program (GLAiD) occurs. The GLAiD intervention is an education and exercise based intervention aiming at decreasing pain and improving function in patients with knee osteoarthritis.
The primary outcome is change in objective recorded physical activity between baseline and follow-up.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark
- The Parker Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥40 years
- Diagnosed with knee OA
- Willing and able to complete study visits and procedures
- Owner of a smartphone or tablet
- Eligible for participation in the GLAID treatment
- Speaks, reads and writes Danish language
Exclusion Criteria:
- Any condition, which in the opinion of the Investigator, would put the subject at increased safety risk by participation, or otherwise make the subject unsuitable for this study.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objectively measured physical activity
Time Frame: 6 weeks
|
accelerometer recorded physical activity
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score(KOOS)
Time Frame: baseline (day 1) and follow-up (after 6 weeks)
|
KOOS questionnaire
|
baseline (day 1) and follow-up (after 6 weeks)
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- InactivityOAIII
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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