A Comparison Between GLA:D Canada and an Individualized JointEffort Exercise Program in Knee Osteoarthritis Patients

NCT ID: NCT03406767

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2020-03-15

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

GLA:D Canada Program

GROUP 1: GLA:DTM CANADA GROUP (STANDARDIZED EXERCISE PROGRAM)

Group Type: EXPERIMENTAL

GLA:D Canada Program

Intervention Type: OTHER

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.

JointEffort Program

GROUP 2: JOINTEFFORT GROUP (INDIVIDUALIZED EXERCISE PROGRAM)

Group Type: EXPERIMENTAL

JointEffort Program

Intervention Type: OTHER

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.

Interventions

GLA:D Canada Program

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.

Intervention Type: OTHER

JointEffort Program

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McCaig Institute for Bone and Joint Health

UNKNOWN

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jackie L Whittaker, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Rehabilitation Medicine, University of Alberta

Locations

McCaig Institute for Bone and Joint Health, University of Calgary

Calgary, Alberta, Canada

Active Living, University of Calgary

Calgary, Alberta, Canada

Sports Medicine Centre, University of Calgary

Calgary, Alberta, Canada

Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00077351

Identifier Type: -

Identifier Source: org_study_id