A Comparison Between GLA:D Canada and an Individualized JointEffort Exercise Program in Knee Osteoarthritis Patients
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

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;

        1. 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?

        2. 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?

        3. 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:

        1. 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?

        2. 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?

        3. 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:

      The objectives of this pre-experimental intervention study are to 1) assess the association
      between participation in the GLA:D® standardized program and functional mobility, quality of
      life, pain management, and inflammatory biomarkers in knee OA patients, 2) assess the
      association between participation in the JointEffort individualized program and functional
      mobility, quality of life, pain management, and inflammatory biomarkers in knee OA patients,
      and 3) assess if there are any differences in outcomes between the standardized (GLA:D®) and
      individualized (JointEffort) exercise programs.

      METHODOLOGY:

      Study Participants: A convenience sample of 60 participants ≥50 years of age with a primary
      care physician or orthopedic surgeon knee OA diagnosis will be included in the study.
      Specifically, 30 individuals will participate in 1) the GLA:D® program and 30 sex- and
      age-matched individuals will participate in 2) the JointEffort program. 60 participants is a
      conservative estimate based on the ability to detect a moderate effect between study groups
      (1-β=0.8, α=0.05).

      Exercise Programs: The GLA:D® program consists of 1) pre- and post-program outcome
      measurement (self-reported and functional outcomes); 2) 2, 1-1.5 hour education sessions
      including information on OA disease characteristics, treatments and self-help strategies; and
      3) a neuromuscular exercise (warm-up, circuit training, and cool down) training program
      administered in 1 hour, small (up to 10 persons) group-based, supervised sessions twice
      weekly for 6 weeks. The goal of the exercises is to restore neutral, functional alignment of
      the legs by building compensatory functional stability and improving sensorimotor control.
      The JointEffort program consists of: 1) one appointment aimed at individualized program
      design; 2) a nutritional seminar taught by a registered dietician explaining dietary
      recommendations for OA patients and inflammatory conditions, including weight loss and/or
      management; and 3) an individualized exercise (strength and neuromuscular training, balance
      training, and range of motion exercises) training program administered in 1 hour, small (up
      to 10 persons) group-based, supervised sessions twice weekly for 6 weeks.

      Study Outcomes:

        1. Demographic (age, sex, height, weight, and body mass index), comorbidity, attendance,
           exercise log, and medication use details will be recorded at each visit. Adherence will
           be measured by exercise program attendance (number of sessions).

        2. The following self-report questionnaires will be completed at baseline, 2, and 12
           months: the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Intermittent and
           Constant Osteoarthritis Pain (ICOAP) Score, and the EuroQOL-5 Dimensions-5 Levels
           (EQ-5D-5L) Score.

        3. The patient knowledge questionnaire on OA (PKQ-OA) and the arthritis self-efficacy
           questionnaire will be completed at baseline, 2, and 12 months.

        4. All participants will complete the 40m Face-Paced Walk Test and the 30s Chair Stand Test
           at baseline, 2, and 12 months.

        5. A blood serum sample, collected at baseline, 2, and 12 months will be analyzed to assess
           for biomarkers (cytokines, chemokines, adipokines, mytokines) using a Discovery Assay
           (42 Custom-Plex human assay) with Luminex-xMAP technology (Eve Technologies).

      STATISTICAL ANALYSIS:

      Descriptive statistics (mean (95% CI), proportion (95% CI) or median (range) will be used
      report the baseline, 2, and 12 month change in self-report, functional and biomarker
      outcomes, as appropriate. To account for the matched design, mean within-pair difference (95%
      CI) will be used to compare treatment groups across outcomes. Finally, conditional logistic
      regression will be used to assess the relationship between attendance (number of sessions)
      and 12-month change in each outcome.

      SIGNIFICANCE:

      This project will contribute to the understanding of exercise programming prescription for
      knee OA patients. If GLA:D® and/or JointEffort support improvements in functional mobility,
      quality of life, pain management, and biomarkers, it could play a role in the implementation
      strategy for OA patients within the province. Exercise programming has the potential to be
      implemented in several sites across Alberta, and thus potentially modifying disease
      progression and possibly delaying total joint replacement.
    

Intervention name(s): GLA:D Canada Program; JointEffort Program
Intervention type(s): Other; Other
Intervention description(s): The GLA:D® program consists of 1) pre- and post-program outcome measurement (self-reported and functional outcomes); 2) 2, 1-1.5 hour education sessions including information on OA disease characteristics, treatments and self-help strategies; and 3) a neuromuscular exercise (warm-up, circuit training, and cool down) training program administered in 1 hour, small (up to 10 persons) group-based, supervised sessions twice weekly for 6 weeks. The goal of the exercises is to restore neutral, functional alignment of the legs by building compensatory functional stability and improving sensorimotor control.; The JointEffort program consists of: 1) one appointment aimed at individualized program design (1-1.5 hours); 2) a nutritional seminar taught by a registered dietician explaining dietary recommendations for OA patients and inflammatory conditions, including weight loss and/or management (1 hours); and 3) an individualized exercise (strength and neuromuscular training, balance training, and range of motion exercises) training program administered in 1 hour, small (up to 10 persons) group-based, supervised sessions twice weekly for 6 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This study involves evaluation of knee osteoarthritis patients who are participating in one of two existing community-based exercise programs (i.e., the GLA:D® or the JointEffort program). Given the pre-experimental design participants will be enrolled after they have registered for one of the two programs (i.e., participants will not be allocated to group assignment) and there is no control group.
The GLA:D® program consists of 1) pre and post program self-reported and functional outcome measures; 2) 2, 1.5 hour education sessions; and 3) neuromuscular exercise training program administered in 1 hour, small (up to 10 persons) group-based, supervised sessions twice weekly for 6 weeks.
The Joint Effort program consists of: 1) one visit aimed at individualized program design; 2) registered dietician led nutrition seminar; and 3) individualized exercise training program administered in 1 hour, small (up to 10 persons) group-based, supervised sessions twice weekly for 6 weeks.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment