Back to resultsRegulation of Intraarticular and Synovium-related Biomarkers of Osteoarthritis. Effect of Acute Mechanical Joint Loading
Primary Purpose
Osteoarthritis, Exercise
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Exercise
Non Exercise
Sponsored by
About this trial
This is an interventional basic science trial for Osteoarthritis focused on measuring osteoarthritis, biochemical markers, cartilage, inflammation, microdialysis
Eligibility Criteria
Inclusion Criteria:
- verified osteoarthritis (x-ray)of the knee, female,
Exclusion Criteria:
- dementia, inflammatory diseases, regular pain medication
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Exercise
Non Exercise
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01090375
First Posted
March 18, 2010
Last Updated
March 18, 2010
Sponsor
Bispebjerg Hospital
Collaborators
The Danish Rheumatism Association, Danish Ministry of Health, Internal Affairs, Danish National Research Council, The Danish Medical Research Council
1. Study Identification
Unique Protocol Identification Number
NCT01090375
Brief Title
Regulation of Intraarticular and Synovium-related Biomarkers of Osteoarthritis. Effect of Acute Mechanical Joint Loading
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bispebjerg Hospital
Collaborators
The Danish Rheumatism Association, Danish Ministry of Health, Internal Affairs, Danish National Research Council, The Danish Medical Research Council
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In the present study the microdialysis method is used to investigate biochemical changes within and around the joint simultaneously in both the resting state and in a joint that had been subjected to exercise. The aim of the present study was, by applying the microdialysis technique, to monitor markers of cartilage breakdown and inflammation in 2 different positions of the knee (inside and in the inner part of the knee capsule) in a group of human females with knee osteoarthritis over a period of 3 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Exercise
Keywords
osteoarthritis, biochemical markers, cartilage, inflammation, microdialysis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Title
Non Exercise
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Type
Other
Intervention Name(s)
Non Exercise
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
Inclusion Criteria:
verified osteoarthritis (x-ray)of the knee, female,
Exclusion Criteria:
dementia, inflammatory diseases, regular pain medication
12. IPD Sharing Statement
Citations:
PubMed Identifier
20594330
Citation
Helmark IC, Mikkelsen UR, Borglum J, Rothe A, Petersen MC, Andersen O, Langberg H, Kjaer M. Exercise increases interleukin-10 levels both intraarticularly and peri-synovially in patients with knee osteoarthritis: a randomized controlled trial. Arthritis Res Ther. 2010;12(4):R126. doi: 10.1186/ar3064. Epub 2010 Jul 1.
Results Reference
derived
Learn more about this trial
Regulation of Intraarticular and Synovium-related Biomarkers of Osteoarthritis. Effect of Acute Mechanical Joint Loading
We'll reach out to this number within 24 hrs