OsteoarthritisNCT02693873
STOP OA: A PILOT STUDY (GLA:D Canada) - Education and Targeted, Personalized Exercise for Hip and Knee Osteoarthritis
A study testing GLA:D Canada (education and neuromuscular exercise program) in people with Osteoarthritis, run by Aileen Davis at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- GLA:D Canada (education and neuromuscular exercise program)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- 7 Mar 2016to 14 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Holland Orthopaedic & Arthritic Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, M4Y 1H1
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- GLA:D Canada (education and neuromuscular exercise program)
- Keywords
- Osteoarthritis, Hip, Osteoarthritis, Knee, Patient Education, Exercise, Neuromuscular, Disease Management, Evidence-Based Health Care, Pilot Study
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Hip, Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLA:D Canada (education and neuromuscular exercise program)Behavioural
Also called GLA:D (Danish program translated for use in Canada)
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).
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study: | Other | All participants will receive GLA:D Canada, an education and neuromuscular exercise program Receives: Behavioral: GLA:D Canada (education and neuromuscular exercise program) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Patient-reported outcome
Measured: 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)
Patient-reported outcome
Measured: Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
EuroQol - EQ-5D-5L
Patient-reported outcome
Measured: Approximately 1-month prior to receiving program (pre-program), 3-months from pre-program, and 12-months from pre-program
Perceived program benefit
Patient-reported; a single question with five response options ranging from 'not at all beneficial to very beneficial'
Measured: 3-months from pre-program and 12-months from pre-program
Overall program satisfaction
Patient-reported; a single question with five response options ranging from 'not at all satisfied to very satisfied'
Measured: 3-months from pre-program and 12-months from pre-program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study start7 Mar 2016
- Primary completion28 Nov 2016
- Study completion14 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- GLA:DCanada Program - Education and targeted, personalized exercise for people with hip and/or knee osteoarthritis
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aileen Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Arthritis Research Centre of Canada, University of Southern Denmark, Bone and Joint Canada
- Responsible party
- Sponsor-investigator, Aileen Davis, University Health Network, Toronto
- Investigators
- Aileen M Davis, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693873
- Sponsor's protocol ID
- GLA:D Canada pilot
- Status last verified
- May 2018
- First submitted
- 19 Feb 2016
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to make individual participant data available.
Publications
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.
PubMed 21733351McAlindon 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.
PubMed 24462672Fernandes 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.
PubMed 23595142Dunlop 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.
PubMed 21792835Nuesch 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.
PubMed 21385807Hawker 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.
PubMed 24608134Rissanen 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.
PubMed 9489250Gunther KP. Surgical approaches for osteoarthritis. Best Pract Res Clin Rheumatol. 2001 Oct;15(4):627-43. doi: 10.1053/berh.2001.0178.
PubMed 11567544Felts W, Yelin E. The economic impact of the rheumatic diseases in the United States. J Rheumatol. 1989 Jul;16(7):867-84.
PubMed 2527991Centers 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.
PubMed 24196662Losina 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.
PubMed 23203864Bennell 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.
PubMed 18687280Brandt 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.
PubMed 18687271Rutherford 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.
PubMed 23357547Fitzgerald 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.
PubMed 15593258
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02693873
- Acronym / sponsor ID
- GLA:D Canada pilot
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Hip, Osteoarthritis, Knee, Patient Education, Exercise, Neuromuscular, Disease Management, Evidence-Based Health Care, Pilot Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Aileen DavisUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Arthritis Research Centre of Canada, University of Southern Denmark, Bone and Joint Canada
- Study start
- 7 Mar 2016 (actual)
- Primary completion
- 28 Nov 2016 (actual)
- Study completion
- 14 Nov 2017 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- GLA:DCanada Program - Education and targeted, personalized exercise for people with hip and/or knee osteoarthritis
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study: | Other | Behavioral: GLA:D Canada (education and neuromuscular exercise program)All participants will receive GLA:D Canada, an education and neuromuscular exercise program |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLA:D Canada (education and neuromuscular exercise program)Also: GLA:D (Danish program translated for use in Canada)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). | Behavioural | Single Arm Study: |
Primary outcome
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
Patient-reported outcome
5 secondary outcomes
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
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
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
Perceived program benefit
Time frame: 3-months from pre-program and 12-months from pre-program
Overall program satisfaction
Time frame: 3-months from pre-program and 12-months from pre-program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Background: PubMed 21733351O'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.
- Background: PubMed 24462672McAlindon 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.
- Background: PubMed 23595142Fernandes 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.
- Background: PubMed 21792835Dunlop 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.
- Background: PubMed 21385807Nuesch 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.
- Background: PubMed 24608134Hawker 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.
- Background: PubMed 9489250Rissanen 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.
- Background: PubMed 11567544Gunther KP. Surgical approaches for osteoarthritis. Best Pract Res Clin Rheumatol. 2001 Oct;15(4):627-43. doi: 10.1053/berh.2001.0178.
- Background: PubMed 2527991Felts W, Yelin E. The economic impact of the rheumatic diseases in the United States. J Rheumatol. 1989 Jul;16(7):867-84.
- Background: PubMed 24196662Centers 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.
- Background: PubMed 23203864Losina 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.
- Background: PubMed 18687280Bennell 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aileen M Davis, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLA:D Canada (education and neuromuscular exercise program) in people with Osteoarthritis, run by Aileen Davis at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02693873, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.