Clinical trial NCT02693873: STOP OA: A PILOT STUDY (GLA:D Canada) - Education and Targeted, Personalized Exercise for Hip and Knee Osteoarthritis
Official title: STOP OA: A PILOT STUDY - Adaptation and Evaluation of a Targeted, Evidence-based, Integrated Patient Education and Exercise Program to Prevent the Progression of Hip and Knee Osteoarthritis Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis, Hip
Osteoarthritis, Knee
Patient Education
Exercise, Neuromuscular
Disease Management
Evidence-Based Health Care
Pilot Study
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: Arthritis Research Centre of Canada
name: University of Southern Denmark
name: Bone and Joint Canada
First posted: 2016-02-29
Enrollment: 61
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: GLA:DCanada Program - Education and targeted, personalized exercise for people with hip and/or knee osteoarthritis
Primary purpose: TREATMENT

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.

Detailed description: Arthritis affects over 4.7 million Canadians and the majority of them have hip and/or knee osteoarthritis (OA). Analysis by the Arthritis Alliance of Canada estimates one new OA diagnosis every 60 seconds. Poorly managed OA results in significant pain and disability, reduced quality of life (QOL), limits work productivity and increases use of health care resources. Two of 3 people are under 65 years and 10 percent of people report pain and functional problems from knee OA by age 60 years. Current evidence indicates that education related to OA integrated with exercises targeted to the hip and/or knee joints are effective in reducing symptoms and improving patient function and QOL. Unfortunately, in Canada, while there are some programs for people with bone and joint problems (e.g. OSTEOFIT, Fit \& Strong) they are general education and exercise programs and are restricted to people over 60 years. In fact, a recent Bone and Joint Canada workshop identified implementation of evidence-based programs as the number one priority. Additionally, our research showed that people under 60 years are looking for strategies to relieve and prevent OA symptom progression. An evidence-based targeted program integrating patient education and exercise for people with hip and knee OA, Good Life with osteoArthritis in Denmark (GLA:D), was implemented in Denmark by collaborator Roos in 2012. GLA:D is delivered by trained physiotherapists and includes patient education sessions and group exercise twice weekly for six weeks. Importantly, exercises are performed in positions and conditions reflecting daily life emphasizing the quality of performance, proper body position and individualized progression based on the patient's ability. The practical nature of these exercises improves adherence to the exercises in the longer term as they are easily transferrable to daily activities. Feasibility, safety and benefit of GLA:D have been demonstrated in individuals with mild to severe hip and knee OA. Since 2012, more than 5000 patients have been educated in GLA:D. Ongoing benefits for more than 2000 patients with one-year follow-up include pain relief with reduced use of medication, improved function and QOL, return to work, and ongoing use of the new knowledge and skills. Given its successful implementation and outcomes, pilot testing of GLA:D Canada and then potential provincial and national implementation and evaluation is highly appealing to address an urgent need for Canadians with hip and knee OA.

Eligibility criteria: Inclusion Criteria:

* 30 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in hip or knee pain intensity with the Numeric Pain Rating Scale (NPRS) (0 no pain to 10 worst pain imaginable)
timeFrame: Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
Secondary outcomes:
measure: Arthritis Self-Efficacy Scale (ASES)
timeFrame: Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
measure: Hip Disability and Osteoarthritis Outcome Score (HOOS) or the Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
measure: EuroQol - EQ-5D-5L
timeFrame: Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
measure: Perceived program benefit
timeFrame: 3-months from pre-program and 12-months from pre-program
measure: Overall program satisfaction
timeFrame: 3-months from pre-program and 12-months from pre-program
Other outcomes:
measure: Rapid Assessment of Physical Activity (RAPA) questionnaire
timeFrame: Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
measure: Patient Knowledge Questionnaire - Osteoarthritis (PKQ-OA)
timeFrame: Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
measure: Number of days in a typical week with at least 30 minutes of physical activity
timeFrame: Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
measure: 30-second chair stand test
timeFrame: Baseline and 3-months from pre-program
measure: 40-metre walk test
timeFrame: Baseline and 3-months from pre-program
Locations:
city: Toronto
country: Canada
facility: Holland Orthopaedic & Arthritic Centre, Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Aileen M Davis, PhD
role: PRINCIPAL_INVESTIGATOR
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