Biomarkers and Knee Osteoarthritis

This study has been completed.
Sponsor:
Collaborator:
Canadian Arthritis Network
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01241812
First received: November 12, 2010
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
Behavioral: Lower limb muscle strengthening
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Biomarkers and Knee Osteoarthritis: Associations With Joint Load and Effects of Exercise

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Serum levels of biomarkers (COMP, HA, C2C, CP2) measured at baseline and 11 weeks [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Urinary levels of biomarkers (CTX-2, C2C) measured at baseline and 11 weeks [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Knee joint loading during walking (external knee adduction moment) measured at baseline and 11 weeks [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Self-reported pain and physical function (WOMAC) measured at baseline and 11 weeks. [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Isometric muscle strength (hamstrings, quadriceps, hip abductors) measured at baseline and 11 weeks [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A.
10 weeks of partially supervised lower limb muscle strengthening targeting the following muscles groups: quadriceps, hamstrings, hip abductors.
Behavioral: Lower limb muscle strengthening
Participants in the exercise group will receive a lower limb strengthening program consisting of 6 exercises targeting the quadriceps, hamstrings, and hip abductor groups. They will perform these exercises at home 4 times per week (3 sets of 10 repetitions per exercise). Over the course of the intervention, each participant will consult with the physiotherapist a total of 5 times (once per week in weeks: 1,2,3,5, and 8) to ensure proper performance of exercises and safe progression of resistance.
No Intervention: B.
Usual care - no intervention
Behavioral: Usual care
Usual care - no intervention

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age greater than 50 years (to meet the American College of Rheumatology clinical definition of OA)
  • radiographically confirmed knee OA in the medial compartment of the tibiofemoral joint
  • knee pain during walking greater than 3/10 (based on an 11-point scale; 0 = "no pain", 10 = "maximal pain") on most days of the previous month
  • predominance of pain/tenderness over the medial (inside) region of the knee

Exclusion Criteria:

  • articular cartilage degradation in the lateral tibiofemoral compartment greater than the medial (medial compartment OA is more common than lateral and the KAM is a validated measure of medial compartment loading only)
  • currently in a structured exercise program
  • medical condition precluding exercise
  • inflammatory arthritic condition
  • history of knee replacement surgery
  • recent use of corticosteroids (oral or via injection)
  • unable to attend exercise training sessions at UBC
  • pain originating predominantly from the patellofemoral joint
  • inability to ambulate without a gait aid
  • non-English speaking (questionnaires are in English and must be completed by the study participant only)
  • recent (within 6 months) arthroscopic knee surgery
  • significant hip or back pain (limits the ability to perform the testing and exercises)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241812

Locations
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Canadian Arthritis Network
Investigators
Principal Investigator: Michael A. Hunt, PT, PhD University of British Columbia
  More Information

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01241812     History of Changes
Other Study ID Numbers: H10-01492
Study First Received: November 12, 2010
Last Updated: October 12, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
knee
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 01, 2014