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Biomarkers and Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lower limb muscle strengthening
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee, osteoarthritis

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A.

B

Arm Description

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

Outcomes

Primary Outcome Measures

Serum levels of biomarkers (COMP, HA, C2C, CP2) measured at baseline and 11 weeks
Urinary levels of biomarkers (CTX-2, C2C) measured at baseline and 11 weeks

Secondary Outcome Measures

Knee joint loading during walking (external knee adduction moment) measured at baseline and 11 weeks
Self-reported pain and physical function (WOMAC) measured at baseline and 11 weeks.
Isometric muscle strength (hamstrings, quadriceps, hip abductors) measured at baseline and 11 weeks

Full Information

First Posted
November 12, 2010
Last Updated
October 10, 2017
Sponsor
University of British Columbia
Collaborators
Canadian Arthritis Network
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1. Study Identification

Unique Protocol Identification Number
NCT01241812
Brief Title
Biomarkers and Knee Osteoarthritis
Official Title
Biomarkers and Knee Osteoarthritis: Associations With Joint Load and Effects of Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Arthritis Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee, osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A.
Arm Type
Experimental
Arm Description
10 weeks of partially supervised lower limb muscle strengthening targeting the following muscles groups: quadriceps, hamstrings, hip abductors.
Arm Title
B
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Lower limb muscle strengthening
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum levels of biomarkers (COMP, HA, C2C, CP2) measured at baseline and 11 weeks
Time Frame
11 weeks
Title
Urinary levels of biomarkers (CTX-2, C2C) measured at baseline and 11 weeks
Time Frame
11 weeks
Secondary Outcome Measure Information:
Title
Knee joint loading during walking (external knee adduction moment) measured at baseline and 11 weeks
Time Frame
11 weeks
Title
Self-reported pain and physical function (WOMAC) measured at baseline and 11 weeks.
Time Frame
11 weeks
Title
Isometric muscle strength (hamstrings, quadriceps, hip abductors) measured at baseline and 11 weeks
Time Frame
11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A. Hunt, PT, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23530976
Citation
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.
Results Reference
derived

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Biomarkers and Knee Osteoarthritis

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