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

NCT03406767 | Completed

• 1 other identifier: Pro00077351
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

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. 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. 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. 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?

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report questionnaire

  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.

  Baseline, 2 and 12 months

Secondary Outcomes (6)

• 40m Fast Paced Walk Test

  Baseline, 2 and 12 months

• 30 Second Chair Stand Physical Function (Strength)

  Baseline, 2 and 12 months

• Serum Biomarkers

  Baseline, 2 and 12 months

• Arthritis-Related Self-Efficacy Scale

  Baseline, 2 and 12 months

• EuroQOL-5 Dimensions self-report questionnaire

  Baseline, 2 and 12 months

Other Outcomes (8)

• Participant Sex

  Baseline

• Participant Age

  Baseline, 2 and 12 months

• Participant Height

  Baseline, 2 and 12 months

Study Arms (2)

GLA:D Canada Program

EXPERIMENTAL

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

Other: GLA:D Canada Program

JointEffort Program

EXPERIMENTAL

GROUP 2: JOINTEFFORT GROUP (INDIVIDUALIZED EXERCISE PROGRAM)

Other: JointEffort Program

Interventions

GLA:D Canada Program 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.

GLA:D Canada Program

JointEffort Program 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.

JointEffort Program

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• McCaig Institute for Bone and Joint Health: collaborator

Study Sites (4)

McCaig Institute for Bone and Joint Health, University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Active Living, University of Calgary

Calgary, Alberta, T2N1N4, Canada

Location

Sports Medicine Centre, University of Calgary

Calgary, Alberta, T2N1N4, Canada

Location

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

Edmonton, Alberta, T6G 2G4, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jackie L Whittaker, PT, PhD

  Faculty of Rehabilitation Medicine, University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 23, 2018
• Study Start: May 1, 2018
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)