Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:24 AM
Study NCT ID:
NCT01241812
Status:
COMPLETED
Last Update Posted:
2017-10-12
First Post:
2010-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers and Knee Osteoarthritis
Sponsor:
University of British Columbia
Organization:
Study Overview
Official Title:
Biomarkers and Knee Osteoarthritis: Associations With Joint Load and Effects of Exercise
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
High joint load during walking has been linked to cartilage degradation. Biomarkers, found in the blood and urine, are protein fragments released after cartilage degradation characteristic of OA. They have the potential to enable direct and immediate disease state monitoring and identification of early cartilage changes. Little is known about the association of biomarkers with joint load or if exercise aimed at reducing joint load changes biomarker levels, thus reducing the risk of OA progression. This study will provide novel information on these relationships and will guide future intervention studies. The investigators hypothesize that certain biomarkers will be highly correlated with joint loading during walking and that the levels of these biomarkers in the blood and urine will decrease following an exercise intervention aimed at cartilage unloading.
Detailed Description:
Participants will be tested twice (baseline and 11 weeks later) where they will undergo gait and strength analyses by the same blinded assessor, complete self-report questionnaires, and have blood and urine samples drawn. Participants will then be randomized into either: (i) exercise; or (ii) usual care (no additional treatment). Those in the exercise group will complete 10-weeks of strengthening targeting lower limb muscles. Once weekly, they will consult with the study physiotherapist (MAH) at UBC to ensure proper performance and safe progression of exercises. Participants will be given cuff weights and resistance bands to complete exercises at home five times per week. Exercise compliance will be monitored using log books. All participants will be encouraged to maintain their usual treatment regimen (except for exercises completed by the exercise group), but will document any unexpected alterations such as medication changes or physician visits.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: