Clinical trial NCT03406767: A Comparison Between GLA:D Canada and an Individualized JointEffort Exercise Program in Knee Osteoarthritis Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: McCaig Institute for Bone and Joint Health
First posted: 2018-01-23
Enrollment: 51
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.

1. 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.
2. 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.
Primary purpose: TREATMENT

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;

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.

Eligibility criteria: Inclusion Criteria:

1. have been diagnosed with OA by a primary care physician or orthopedic surgeon;
2. ≥50 years of age;
3. are able read, understand, and provide informed consent in English; and
4. can attend exercise programming classes at the University of Calgary.

Exclusion Criteria:

1. have physical or neurological impairments or pre-existing medical conditions where physical activity is contraindicated;
2. have inflammatory arthritis, a fracture, tumor, or acute trauma; and
3. participated in the JointEffort or GLA:D program previously.

Primary outcomes:
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report questionnaire
timeFrame: Baseline, 2 and 12 months
Secondary outcomes:
measure: 40m Fast Paced Walk Test
timeFrame: Baseline, 2 and 12 months
measure: 30 Second Chair Stand Physical Function (Strength)
timeFrame: Baseline, 2 and 12 months
measure: Serum Biomarkers
timeFrame: Baseline, 2 and 12 months
measure: Arthritis-Related Self-Efficacy Scale
timeFrame: Baseline, 2 and 12 months
measure: EuroQOL-5 Dimensions self-report questionnaire
timeFrame: Baseline, 2 and 12 months
measure: Intermittent and Constant Osteoarthritis Pain self-report questionnaire
timeFrame: Baseline, 2 and 12 months
Other outcomes:
measure: Participant Sex
timeFrame: Baseline
measure: Participant Age
timeFrame: Baseline, 2 and 12 months
measure: Participant Height
timeFrame: Baseline, 2 and 12 months
measure: Participant Weight
timeFrame: Baseline, 2 and 12 months
measure: Participant Body Mass Index (BMI)
timeFrame: Baseline, 2 and 12 months
measure: Participant Medical Comorbidities
timeFrame: Baseline, 2 and 12 months
measure: Intervention Adherence
timeFrame: Two visits per week over the six weeks of the intervention
measure: Medication Use
timeFrame: Baseline, daily over the six week intervention, 2 and 12 months
Locations:
city: Calgary
country: Canada
facility: McCaig Institute for Bone and Joint Health, University of Calgary
state: Alberta
city: Calgary
country: Canada
facility: Active Living, University of Calgary
state: Alberta
city: Calgary
country: Canada
facility: Sports Medicine Centre, University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta
state: Alberta
Study officials:
affiliation: Faculty of Rehabilitation Medicine, University of Alberta
name: Jackie L Whittaker, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: