A Comparison Between a Standardized (GLA:D Canada) and an Individualized (JointEffort) Exercise Program on Functional Mobility, Quality of Life, Pain Management, and Inflammatory Biomarkers in Knee Osteoarthritis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Alberta
- Enrollment
- 51
- Locations
- 4
- Primary Endpoint
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report questionnaire
Study Overview
Brief Summary
Osteoarthritis (OA) is the leading cause of disability worldwide and affects more than 4.4 million people in Canada (13% of Canadians). OA symptoms include joint pain, stiffness, range of motion loss, and inflammation, resulting in a significant decrease in quality of life. Current evidence-based guidelines for OA management recommend weight loss, patient education, exercise therapy, bracing, viscosupplementation, and anti-inflammatory/pain medications prior to joint replacement surgery. Unfortunately, current practice trends are not consistent with these guidelines and focus largely on joint replacement. Recently, research from a group in Denmark has shown a reduction in the progression of knee OA symptoms, joint related painkiller use, individuals on sick leave, and higher physical activity levels 12 months after a combined patient education and standardized group exercise therapy program (GLA:D®). Based on the Danish success, the GLA:D® program has been made available in Canada. To date it is unclear if the GLA:DTM Canada program will result in outcomes similar to those seen in Denmark, or how the GLA:DTM program compares to existing individualized OA care programs (i.e. JointEffort). This research will answer the following three questions;
- Is the GLA:DTM standardized education and exercise program associated with improvements in functional mobility, quality of life, pain management, and inflammatory biomarkers in knee OA patients in Calgary, Alberta?
- Is the JointEffort individualized exercise and education program associated with improved functional mobility, quality of life, pain management, and inflammatory biomarkers in knee OA patients in Calgary, Alberta?
- Do the improvements in functional mobility, quality of life, pain management, and inflammatory biomarkers in knee OA patients differ between those enrolled in the GLA:DTM and the JointEffort education and exercise programs?
Detailed Description
BACKGROUND:
Osteoarthritis (OA) is the leading cause of disability worldwide and affects more than 4.4 million people in Canada (13% of Canadians). OA symptoms include joint pain, stiffness, range of motion loss, and inflammation, resulting in a significant decrease in quality of life. Current evidence-based guidelines for OA management recommend weight loss, patient education, exercise therapy, bracing, viscosupplementation, and anti-inflammatory/pain medications prior to joint replacement surgery. Unfortunately, current practice trends are not consistent with these guidelines and focus largely on joint replacement. Recently, research from a group in Denmark has shown a reduction in the progression of knee OA symptoms, joint related painkiller use, individuals on sick leave, and higher physical activity levels 12 months after a combined patient education and standardized group exercise therapy program (GLA:D®). Based on the Danish success, the GLA:D® program has been made available in Canada. To date it is unclear if the GLA:D® Canada program will result in outcomes similar to those seen in Denmark, or how the GLA:D® program compares to existing individualized OA care programs (i.e. JointEffort).
RESEARCH QUESTIONS:
- Is the GLA:D® standardized education and exercise program associated with improvements in functional mobility, quality of life, pain management, and biomarkers in knee OA patients in Alberta?
- Is the JointEffort individualized exercise and education program associated with improved functional mobility, quality of life, pain management, and biomarkers in knee OA patients in Alberta?
- Do the improvements in functional mobility, quality of life, pain management, and biomarkers in knee OA patients differ between those enrolled in the GLA:D® and the JointEffort education and exercise programs?
OBJECTIVES:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
As both intervention arms are exercise-based it is impossible to mask the participants or individuals delivering the programs.
All outcome measurements will be performed by a research assistant who is blinded to participant group assignment.
Eligibility Criteria
- Ages
- 50 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •have been diagnosed with OA by a primary care physician or orthopedic surgeon;
- •≥50 years of age;
- •are able read, understand, and provide informed consent in English; and
- •can attend exercise programming classes at the University of Calgary.
Exclusion Criteria
- •have physical or neurological impairments or pre-existing medical conditions where physical activity is contraindicated;
- •have inflammatory arthritis, a fracture, tumor, or acute trauma; and
- •participated in the JointEffort or GLA:D program previously.
Arms & Interventions
GLA:D Canada Program
GROUP 1: GLA:DTM CANADA GROUP (STANDARDIZED EXERCISE PROGRAM)
Intervention: GLA:D Canada Program (Other)
JointEffort Program
GROUP 2: JOINTEFFORT GROUP (INDIVIDUALIZED EXERCISE PROGRAM)
Intervention: JointEffort Program (Other)
Outcomes
Primary Outcomes
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report questionnaire
Time Frame: Baseline, 2 and 12 months
The KOOS self-report questionnaire \[17\] will be used to evaluate changes in symptoms and function related to knee OA at baseline, 2 and 12 months. Changes from baseline will be reported. The KOOS consists of 42 items in five subscales (pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life) scored on a 5-point Likert scale. Subscale scores will be summed and the total score transformed to a 0-100 scale with higher scores indicating better function.
Secondary Outcomes
- Arthritis-Related Self-Efficacy Scale(Baseline, 2 and 12 months)
- Intermittent and Constant Osteoarthritis Pain self-report questionnaire(Baseline, 2 and 12 months)
- 40m Fast Paced Walk Test(Baseline, 2 and 12 months)
- Serum Biomarkers(Baseline, 2 and 12 months)
- EuroQOL-5 Dimensions self-report questionnaire(Baseline, 2 and 12 months)
- 30 Second Chair Stand Physical Function (Strength)(Baseline, 2 and 12 months)