- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02693873
STOP OA: A PILOT STUDY (GLA:D Canada) - Education and Targeted, Personalized Exercise for Hip and Knee Osteoarthritis
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4Y 1H1
- Holland Orthopaedic & Arthritic Centre, Sunnybrook Health Sciences Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Single Arm Study:
All participants will receive GLA:D Canada, an education and neuromuscular exercise program
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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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in hip or knee pain intensity with the Numeric Pain Rating Scale (NPRS) (0 no pain to 10 worst pain imaginable)
Time Frame: Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
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Patient-reported outcome
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Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arthritis Self-Efficacy Scale (ASES)
Time Frame: Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
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Patient-reported outcome
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Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
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Hip Disability and Osteoarthritis Outcome Score (HOOS) or the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
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Patient-reported outcome
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Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
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EuroQol - EQ-5D-5L
Time Frame: Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
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Patient-reported outcome
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Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
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Perceived program benefit
Time Frame: 3-months from pre-program and 12-months from pre-program
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Patient-reported; a single question with five response options ranging from 'not at all beneficial to very beneficial'
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3-months from pre-program and 12-months from pre-program
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Overall program satisfaction
Time Frame: 3-months from pre-program and 12-months from pre-program
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Patient-reported; a single question with five response options ranging from 'not at all satisfied to very satisfied'
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3-months from pre-program and 12-months from pre-program
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rapid Assessment of Physical Activity (RAPA) questionnaire
Time Frame: Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
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Patient-reported outcome
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Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
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Patient Knowledge Questionnaire - Osteoarthritis (PKQ-OA)
Time Frame: Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
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Patient-reported outcome
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Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
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Number of days in a typical week with at least 30 minutes of physical activity
Time Frame: Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
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Patient-reported outcome
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Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
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30-second chair stand test
Time Frame: Baseline and 3-months from pre-program
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Administered by the therapist delivering GLA:D
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Baseline and 3-months from pre-program
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40-metre walk test
Time Frame: Baseline and 3-months from pre-program
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Administered by the therapist delivering GLA:D
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Baseline and 3-months from pre-program
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aileen M Davis, PhD, University Health Network, Toronto
Publications and helpful links
General Publications
- Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
- Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
- Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107.
- Ageberg E, Link A, Roos EM. Feasibility of neuromuscular training in patients with severe hip or knee OA: the individualized goal-based NEMEX-TJR training program. BMC Musculoskelet Disord. 2010 Jun 17;11:126. doi: 10.1186/1471-2474-11-126.
- McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
- Skou ST, Odgaard A, Rasmussen JO, Roos EM. Group education and exercise is feasible in knee and hip osteoarthritis. Dan Med J. 2012 Dec;59(12):A4554.
- Skou ST, Simonsen ME, Odgaard A, Roos EM. Predictors of long-term effect from education and exercise in patients with knee and hip pain. Dan Med J. 2014 Jul;61(7):A4867.
- Jensen MP, McFarland CA. Increasing the reliability and validity of pain intensity measurement in chronic pain patients. Pain. 1993 Nov;55(2):195-203. doi: 10.1016/0304-3959(93)90148-I.
- Nuesch E, Dieppe P, Reichenbach S, Williams S, Iff S, Juni P. All cause and disease specific mortality in patients with knee or hip osteoarthritis: population based cohort study. BMJ. 2011 Mar 8;342:d1165. doi: 10.1136/bmj.d1165.
- Topolski TD, LoGerfo J, Patrick DL, Williams B, Walwick J, Patrick MB. The Rapid Assessment of Physical Activity (RAPA) among older adults. Prev Chronic Dis. 2006 Oct;3(4):A118. Epub 2006 Sep 15.
- Losina E, Weinstein AM, Reichmann WM, Burbine SA, Solomon DH, Daigle ME, Rome BN, Chen SP, Hunter DJ, Suter LG, Jordan JM, Katz JN. Lifetime risk and age at diagnosis of symptomatic knee osteoarthritis in the US. Arthritis Care Res (Hoboken). 2013 May;65(5):703-11. doi: 10.1002/acr.21898.
- Bennell KL, Hunt MA, Wrigley TV, Lim BW, Hinman RS. Role of muscle in the genesis and management of knee osteoarthritis. Rheum Dis Clin North Am. 2008 Aug;34(3):731-54. doi: 10.1016/j.rdc.2008.05.005.
- Fernandes L, Hagen KB, Bijlsma JW, Andreassen O, Christensen P, Conaghan PG, Doherty M, Geenen R, Hammond A, Kjeken I, Lohmander LS, Lund H, Mallen CD, Nava T, Oliver S, Pavelka K, Pitsillidou I, da Silva JA, de la Torre J, Zanoli G, Vliet Vlieland TP; European League Against Rheumatism (EULAR). EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis. 2013 Jul;72(7):1125-35. doi: 10.1136/annrheumdis-2012-202745. Epub 2013 Apr 17.
- Fitzgerald GK, Piva SR, Irrgang JJ. Reports of joint instability in knee osteoarthritis: its prevalence and relationship to physical function. Arthritis Rheum. 2004 Dec 15;51(6):941-6. doi: 10.1002/art.20825.
- Centers for Disease Control and Prevention (CDC). Prevalence of doctor-diagnosed arthritis and arthritis-attributable activity limitation--United States, 2010-2012. MMWR Morb Mortal Wkly Rep. 2013 Nov 8;62(44):869-73.
- Rutherford DJ, Hubley-Kozey CL, Stanish WD. Changes in knee joint muscle activation patterns during walking associated with increased structural severity in knee osteoarthritis. J Electromyogr Kinesiol. 2013 Jun;23(3):704-11. doi: 10.1016/j.jelekin.2013.01.003. Epub 2013 Jan 26.
- O'Donnell S, Lagace C, McRae L, Bancej C. Life with arthritis in Canada: a personal and public health challenge. Chronic Dis Inj Can. 2011 Jun;31(3):135-6.
- Dunlop DD, Song J, Semanik PA, Chang RW, Sharma L, Bathon JM, Eaton CB, Hochberg MC, Jackson RD, Kwoh CK, Mysiw WJ, Nevitt MC, Hootman JM. Objective physical activity measurement in the osteoarthritis initiative: Are guidelines being met? Arthritis Rheum. 2011 Nov;63(11):3372-82. doi: 10.1002/art.30562.
- Hawker GA, Croxford R, Bierman AS, Harvey PJ, Ravi B, Stanaitis I, Lipscombe LL. All-cause mortality and serious cardiovascular events in people with hip and knee osteoarthritis: a population based cohort study. PLoS One. 2014 Mar 7;9(3):e91286. doi: 10.1371/journal.pone.0091286. eCollection 2014.
- Rissanen P, Aro S, Sintonen H, Asikainen K, Slatis P, Paavolainen P. Costs and cost-effectiveness in hip and knee replacements. A prospective study. Int J Technol Assess Health Care. 1997 Fall;13(4):575-88. doi: 10.1017/s0266462300010059.
- Gunther KP. Surgical approaches for osteoarthritis. Best Pract Res Clin Rheumatol. 2001 Oct;15(4):627-43. doi: 10.1053/berh.2001.0178.
- Felts W, Yelin E. The economic impact of the rheumatic diseases in the United States. J Rheumatol. 1989 Jul;16(7):867-84.
- Brandt KD, Dieppe P, Radin EL. Etiopathogenesis of osteoarthritis. Rheum Dis Clin North Am. 2008 Aug;34(3):531-59. doi: 10.1016/j.rdc.2008.05.011.
- Ageberg E. Consequences of a ligament injury on neuromuscular function and relevance to rehabilitation - using the anterior cruciate ligament-injured knee as model. J Electromyogr Kinesiol. 2002 Jun;12(3):205-12. doi: 10.1016/s1050-6411(02)00022-6.
- Hill J, Bird H. Patient knowledge and misconceptions of osteoarthritis assessed by a validated self-completed knowledge questionnaire (PKQ-OA). Rheumatology (Oxford). 2007 May;46(5):796-800. doi: 10.1093/rheumatology/kel407. Epub 2006 Dec 18.
- Lorig K, Holman H. Arthritis Self-Efficacy Scales measure self-efficacy. Arthritis Care Res. 1998 Jun;11(3):155-7. doi: 10.1002/art.1790110302. No abstract available.
- Bredin SS, Gledhill N, Jamnik VK, Warburton DE. PAR-Q+ and ePARmed-X+: new risk stratification and physical activity clearance strategy for physicians and patients alike. Can Fam Physician. 2013 Mar;59(3):273-7. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLA:D Canada pilot
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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