STOP OA: A PILOT STUDY (GLA:D Canada) - Education and Targeted, Personalized Exercise for Hip and Knee Osteoarthritis

NCT02693873 | Completed

• 1 other identifier: GLA:D Canada pilot
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) most often affects the hip and knee joints. The first signs and symptoms of pain, stiffness or swelling are not uncommon in those in their thirties and forties and 10 per cent report symptomatic knee OA by age 60 years. Education and exercise are essential for people with OA to help them manage their condition better. Exercise can reduce pain, improve mobility and enhance quality of life. However, doing the right exercises in the right way is important so that joints are not overly stressed. The purpose of this study is to evaluate an existing evidence-based program called, Good Life with osteoArthritis in Denmark (GLA:D). The program has been translated and adapted to the Canadian context and will now be implemented in a Canadian therapy setting to start to understand if it is effective. This is the first time this program is being tested in Canada. While some people have access to self-management programs for OA, these programs often provide only general exercise guidance and education. GLA:D integrates patient education and targeted, personalized exercise for people with hip and/or knee OA. Importantly, the exercises are taught so that individuals learn to incorporate them in their everyday activities. This research is the first step to understanding if people participating in this program have pain relief and improved function and if they are better able to manage their hip or knee OA symptoms. Additionally, this initial evaluation of the program will help create a better understanding of the challenges in delivering the program. This will be valuable information for offering future programs assuming success of this pilot study. It is anticipated that about 60 people (30 hip OA and 30 knee OA) will participate in this study. These people will be recruited from the Sunnybrook Holland Orthopaedic and Arthritic Centre in Toronto, Ontario, Canada. All consenting participants will receive the GLA:D Canada program delivered by Sunnybrook's therapists.

Conditions

Osteoarthritis

Keywords

Osteoarthritis, Hip; Osteoarthritis, Knee; Patient Education; Exercise, Neuromuscular; Disease Management; Evidence-Based Health Care; Pilot Study

Outcome Measures

Primary Outcomes (1)

• Change in hip or knee pain intensity with the Numeric Pain Rating Scale (NPRS) (0 no pain to 10 worst pain imaginable)

  Patient-reported outcome

  Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program

Secondary Outcomes (5)

• Arthritis Self-Efficacy Scale (ASES)

  Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program

• Hip Disability and Osteoarthritis Outcome Score (HOOS) or the Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program

• EuroQol - EQ-5D-5L

  Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program

• Perceived program benefit

  3-months from pre-program and 12-months from pre-program

• Overall program satisfaction

  3-months from pre-program and 12-months from pre-program

Other Outcomes (5)

• Rapid Assessment of Physical Activity (RAPA) questionnaire

  Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program

• Patient Knowledge Questionnaire - Osteoarthritis (PKQ-OA)

  Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program

• Number of days in a typical week with at least 30 minutes of physical activity

  Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program

Study Arms (1)

Single Arm Study:

OTHER

All participants will receive GLA:D Canada, an education and neuromuscular exercise program

Behavioral: GLA:D Canada (education and neuromuscular exercise program)

Interventions

GLA:D Canada (education and neuromuscular exercise program) BEHAVIORAL

EDUCATION: 2 sessions cover OA topics (e.g. diagnosis, causes, risk factors, symptoms, treatment). Education also aims to strengthen beliefs in the value of exercise to control and improve pain and encourage exercise adherence after the program. EXERCISE: 12 sessions (twice weekly, each about 1-hour) are supervised by therapist(s) with individual progression of exercises when good neuromuscular functioning is demonstrated. Exercises are performed using both legs and focus on sensorimotor control, functional stability, and muscular strength. Exercises involve a 10-minute cycle warm-up followed by a 4-station circuit (i.e. 2 exercises per station with 3 progressive levels of difficulty performed in 2 to 3 sets with 10 to 15 repetitions).

Also known as: GLA:D (Danish program translated for use in Canada)

Single Arm Study:

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Hip or knee osteoarthritis diagnosed by a health care provider
• Not a candidate for total joint replacement surgery at the present time
• Fluent in English

You may not qualify if:

• Arthritis other than osteoarthritis
• Prior or booked total joint replacement
• Acute knee injury in last 6-months
• Inability to follow instructions and/or to provide consent
• Health condition precluding exercise

Sponsors & Collaborators

• Aileen Davis: lead
• Sunnybrook Health Sciences Centre: collaborator
• Arthritis Research Centre of Canada: collaborator
• University of Southern Denmark: collaborator
• Bone and Joint Canada: collaborator

Study Sites (1)

Holland Orthopaedic & Arthritic Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4Y 1H1, Canada

Location

Related Publications (27)

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Related Links

• Click here for more information about the GLA:D program. Working with researchers from Denmark, Bone and Joint Canada has launched the "GLA:D Canada" program at Sunnybrook Health Sciences Centre.

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Hip; Osteoarthritis, Knee; Motor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Aileen M Davis, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Scientist

Model Details: GLA:DCanada Program - Education and targeted, personalized exercise for people with hip and/or knee osteoarthritis

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: February 29, 2016
• Study Start: March 7, 2016
• Primary Completion: November 28, 2016
• Study Completion: November 14, 2017
• Last Updated: May 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)