Biomarkers and Knee Osteoarthritis

NCT01241812 | Completed

• 1 other identifier: H10-01492
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

knee; osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Serum levels of biomarkers (COMP, HA, C2C, CP2) measured at baseline and 11 weeks

  11 weeks

• Urinary levels of biomarkers (CTX-2, C2C) measured at baseline and 11 weeks

  11 weeks

Secondary Outcomes (3)

• Knee joint loading during walking (external knee adduction moment) measured at baseline and 11 weeks

  11 weeks

• Self-reported pain and physical function (WOMAC) measured at baseline and 11 weeks.

  11 weeks

• Isometric muscle strength (hamstrings, quadriceps, hip abductors) measured at baseline and 11 weeks

  11 weeks

Study Arms (2)

A.

EXPERIMENTAL

10 weeks of partially supervised lower limb muscle strengthening targeting the following muscles groups: quadriceps, hamstrings, hip abductors.

Behavioral: Lower limb muscle strengthening

B

NO INTERVENTION

Interventions

Lower limb muscle strengthening BEHAVIORAL

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.

A.

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Arthritis Network: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, Canada

Location

Related Publications (1)

• Hunt MA, Pollock CL, Kraus VB, Saxne T, Peters S, Huebner JL, Sayre EC, Cibere J. Relationships amongst osteoarthritis biomarkers, dynamic knee joint load, and exercise: results from a randomized controlled pilot study. BMC Musculoskelet Disord. 2013 Mar 27;14:115. doi: 10.1186/1471-2474-14-115.

  PMID: 23530976 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michael A. Hunt, PT, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Motion Analysis and Biofeedback Lab

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 16, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 12, 2017

Record last verified: 2017-10

Locations

CA (1)