Osteo Arthritis KneeTEAMNCT04544904
The Technology, Exercise Programming, and Activity Prescription for Enhanced Mobility (TEAM) Study
A study testing PAARx and JM in people with Osteo Arthritis Knee and Osteoarthritis, run by Western University, Canada at 1 site in Canada.
Trial summary
Many individuals with osteoarthritis (OA) (up to 45%) are referred to an orthopaedic surgeon for a joint replacement prematurely or will not be candidates for surgery. These individuals need appropriate (non-operative) care to help reduce their pain and enhance their mobility. Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Osteo Arthritis Knee, Osteoarthritis, Hip Arthritis
- What is being tested?
- PAARx and JM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jun 2021to 1 Jun 2026
- 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 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40-74 years of age
- Screened by the Southwest Musculoskeletal RAC as "mild to moderate OA" using clinical and radiographic criteria
Who cannot join
- Concomitant end-stage OA (awaiting/prior TJA)
- Inflammatory arthritis (rheumatoid, psoriatic, or disease-modifying anti-rheumatic drug exposure)
- Unstable medical conditions that would preclude physical activity prescription (e.g. unstable angina, uncontrolled Type 2 Diabetes)
- Not able/willing to follow up for the study period
- Does not have access to the internet
- Cannot communicate in English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Uses of Technology for Individuals With Mild to Moderate Hip or Knee Osteoarthritis: The Technology, Exercise Programming, and Activity Prescription for Enhanced Mobility (TEAM) Study
Many individuals with osteoarthritis (OA) (up to 45%) are referred to an orthopaedic surgeon for a joint replacement prematurely or will not be candidates for surgery. These individuals need appropriate (non-operative) care to help reduce their pain and enhance their mobility. We are studying the use of innovative technology to help physicians give physical activity advice for patients to become more active and provide free online resources to help patients understand OA self-management and exercise, especially when they have barriers to accessing formal care. Individuals with OA that are referred to a specialized clinic will receive one of three interventions: usual care (handout on resources), a physical activity prescription by a doctor, or the prescription and a link to a free web-based platform (website) on non-operative management of OA with patient education and exercise videos. Our goal is to help with non-operative management strategies to improve quality of life, reduce pain, improve mobility, and possibly delay or prevent a joint replacement.
Osteoarthritis is a condition where people feel joint pain or stiffness. Joints are the body parts where two bones join together with softer material (cartilage) between them. In osteoarthritis, this cartilage wears down. It is the biggest cause for disability worldwide. Helping people with osteoarthritis starts with education, physical activity, and physiotherapy. Doctors can also prescribe braces, injections or medications. For severe osteoarthritis when nothing else helps, surgery can be done to replace the joint.
Read more
Doctors often refer patients for surgery too soon. Skipping steps of care may mean unnecessary surgery and longer wait times. The Musculoskeletal Rapid Access Clinic (now called Clinic) in London was set up to solve these problems. They screen patients before referring them to a surgeon, and do not refer almost half of patients. Our goal is to support these patients with new ways to make their non-surgical treatment better.
The first way is through physical activity 'prescription'. It works well for other chronic conditions and patients say it helps. We don't know how well it works for people with osteoarthritis. Most doctors have little time, training or experience for prescribing physical activity. Technology can make it easier for doctors and patients. We have designed a tool to help doctors prescribe physical activity and a smartphone app to track patient activity. We have also created a free website. This includes patient education, exercise videos, and virtual physiotherapy. This can be important for individuals who can't access in-person care.
Read the detailed description
Osteoarthritis (OA) is the leading cause of disability worldwide and affects more than 4.4 million Canadians. Current evidence-based guidelines for OA management recommend weight management, patient education, physical activity, physiotherapy (PT), bracing, viscosupplementation, and anti-inflammatory/pain medications prior to joint replacement surgery. Unfortunately, current practice trends are not consistent with these guidelines, as nearly half of patients with OA referred to orthopedic surgeons do not require total joint arthroplasty (TJA) at the time of initial consultation. Through the Southwest Musculoskeletal Rapid Access Clinic (RAC), approximately ten referrals (20%) are rejected each day due to OA criteria not met, and a further 20% are assessed as non-operative.
We aim to identify individuals with 'mild to moderate' OA and optimize their first-line non-operative management, starting with physical activity and education.
Physical activity prescriptions are effective in increasing patient levels of physical activity, and 93% of patients surveyed want advice on physical activity from their physicians; but it is underused.
Physicians cite lack of time and inadequate training as barriers. Electronic screening of physical activity behaviours can save time for physicians, and the use of digital health tools can improve physical activity levels.
Patient education and physiotherapist-led group exercise therapy programs have shown to delay progression of knee OA symptoms and improve pain and function; however, two of the most significant barriers to accessing exercise programming is the cost (~approximate $425-475 per 6-8-week session) and accessibility to attend the exercise session (proximity to facility, remote/rural communities, etc.).
The Need for a Solution that targets both Providers and Patients Screening for baseline physical activity levels and including educational components significantly increase intervention effectiveness.
We have previously tested the feasibility of implementing an e-health tool to support physical activity counselling by physicians during patients' periodic health review. We will adapt and implement this tool, Physical Activity and App Prescription (PARx) to screen and provide tailored resources for physical activity in the setting of OA. We will use tablet computers and email, directly linked with the electronic medical record (EMR), to engage patients in contemplating their own physical activity levels, start conversations with their healthcare providers (in this case, primary care physicians with additional training in sport and exercise medicine), and support customized, patient-centered health care. After patients enter their information, they will receive evidence-based behavioural change supports to help them meet their goals.
The automated algorithm assesses current activity level, risk factors/comorbidities and readiness for change. Based on the answers provided, patients are risk-stratified and tailored resources will be provided to the patient and to their clinician in the form of decision support tools embedded in the EMR. This will include the novel implementation of an exercise tracking platform via the smartphone app (myrecovery.ai).
The web-based platform Joint Management (JM) is a free, readily accessible evidenced-based resource focusing on non-operative management strategies for mild to moderate hip and knee OA. The platform will include exercise programming (videos, pictures, and descriptions of the exercises) and patient education (benefits of exercise, lifestyle modifications, nutrition, injections, etc.), to assist the patient engage in self-management. JM will also include the option for (paid) virtual access to PTs, who can provide individualized support, recommendations and exercise programming via the platform.
RATIONALE:
Creating customized physical activity plans with automated reminders and other supports addresses the problem of self-efficacy in providers by developing an evidence-based automated method, while also addressing the issue of patient adherence by using tailored behaviour change techniques, through assessing readiness for change, and helping patients create new habits.
The motivation for JM is to create a free, online evidence-based OA education and exercise programming resource for those that are not able to afford or access community-based exercise programs. The virtual PT option will help optimize patient's experience with the web-based platform, offering support and personalized recommendations regarding management of their condition and exercise programming tailored to their specific abilities, preferences, and needs.
Why this is Innovative:
The evidence for using patient-reported measures and functional outcomes to guide quality improvement for personalized OA care in a systematic manner is in an early stage, meaning that this project can not only impact healthcare delivery and translate new knowledge into medical practice but help position Western University as a leader in this area. The novel technologies (PARx and JM) are innovative tools informed by patient priorities and co-designed with our patient partners, specifically geared towards 1) developing new and more personalized treatment approaches, 2) developing more effective self-management tools, and 3) reducing disparities in vulnerable and hard-to-reach populations. To this end, we will share our findings broadly with our patient partners and reach out to these harder-to-reach groups in particular.
EXPECTED OUTCOMES:
Health Outcomes: We expect to increase patients' physical activity and improve outcomes for individuals with mild to moderate OA. We aim to optimize non-operative management of OA symptoms and therefore possibly delay and/or prevent the need for TJA.
Academic Outcomes: We expect to develop a model of physical activity prescription and patient education that can be scaled up for implementation in primary care.
Societal Outcomes: Both novel technologies have the potential to be implemented across Canada, targeting modifying disease progression and, ideally, delaying or preventing TJA.
Innovative Technology 1: Physical Activity (PA) and App Prescription (Rx) (PARx) Physical Activity and App Prescription (PARx): Tablet/email software (REDCap) is used to collect physical activity data from patient input and prompt intervention by providers. The automated algorithm assesses current activity level, risk factors/comorbidities and readiness for change. Based upon their answers, patients will be risk-stratified and tailored resources will be provided to them in the form of a personalized prescription and free smartphone app (myrecovery.ai) to track activity levels.
Innovative Technology 2: Joint Management (JM) Joint Management (JM): This is a free online evidence-based OA education and exercise programming resource for those that are not able to afford or access community-based exercise programs, with a virtual physiotherapy (PT) option to offer support and personalized recommendations.
OBJECTIVES:
The objective of the proposed study is to 1) determine if PARx and JM will improve pain, increase physical activity levels, and improve functional outcomes in patients with mild to moderate hip or knee OA
RESEARCH QUESTIONS:
- Does the use of novel technology (PARx) affect patient reported outcomes in individuals with mild to moderate hip or knee OA?
- Does PARx influence activity levels in individuals with mild to moderate hip or knee OA?
- Does the use of novel technology (PARx and JM) affect patient reported and functional outcomes in individuals with mild to moderate hip or knee OA?
- What are the experiences and perceptions of patients and physicians during this process?
SPECIFIC AIMS:
Measure and compare A1) patient reported outcomes (pain, joint stiffness, disability, quality of life, disease knowledge, self-efficacy, depression, and fatigue), A2) physical activity levels, and A3) functional outcomes with those that have access (PARx and JM) and those that do not have access (usual care) to the technology. Determine A4) participant and physician experiences.
HYPOTHESES:
We hypothesize that access to technology-facilitated physical activity prescription (PARx) and access to the web-based platform (JM) will H1) improve patient reported outcomes (pain, joint stiffness, disability, quality of life, disease knowledge, self-efficacy, depression, and fatigue), H2) increase PA levels, and H3) improve functional outcomes in individuals with mild to moderate hip or knee OA compared to usual care. We hypothesize that access to JM will result in a greater improvement than PARx alone.
- Conditions
- Osteo Arthritis Knee, Osteoarthritis, Hip Arthritis
- Being tested
- PAARx, JM
- Keywords
- exercise, physical activity, medicine
- Medical subject headings
- Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAARxDevice
Prescription Physical Activity Programming Application
JMDevice
Joint Management (JM) web-based joint management resource.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients will receive the usual care. |
| PAARx | Experimental | Patients will be prescribed technology-based physical activity programming. Receives: Device: PAARx |
| PAARx and JM | Experimental | Patients will be prescribed technology-based physical activity programming and be referred to a web-based resource for evidence-based joint management. Receives: Device: PAARx; Device: JM |
What is being measured
The primary outcome is the main question the study is designed to answer.
height
height in cm
Measured: Baseline
height
height in cm
Measured: 2 months
height
height in cm
Measured: 6 months
height
height in cm
Measured: 12 months
body mass index (derived)
body mass index as calculated with height and weight
Measured: Baseline
body mass index (derived)
body mass index as calculated with height and weight
Measured: 2 months
body mass index (derived)
body mass index as calculated with height and weight
Measured: 6 months
body mass index (derived)
body mass index as calculated with height and weight
Measured: 12 months
abdominal circumference
abdominal circumference in cm
Measured: Baseline
abdominal circumference
abdominal circumference in cm
Measured: 2 months
abdominal circumference
abdominal circumference in cm
Measured: 6 months
abdominal circumference
abdominal circumference in cm
Measured: 12 months
weight
weight kg
, weight, body mass index (derived), abdominal circumference, and medical history to assess for comorbid disease.
Measured: Baseline
weight
weight kg
, weight, body mass index (derived), abdominal circumference, and medical history to assess for comorbid disease.
Measured: 2 months
weight
weight kg
, weight, body mass index (derived), abdominal circumference, and medical history to assess for comorbid disease.
Measured: 6 months
weight
weight kg
, weight, body mass index (derived), abdominal circumference, and medical history to assess for comorbid disease.
Measured: 12 months
PA Evaluation
PA levels will be measured as a composite measure using smartphone app/accelerometer data (myrecovery.ai; steps per day, light/moderate/vigorous activity, and total MET-min) via the International PA Questionnaire - Short Form (IPAQ-SF) [15].
Measured: Baseline
PA Evaluation
PA levels will be measured as a composite measure using smartphone app/accelerometer data (myrecovery.ai; steps per day, light/moderate/vigorous activity, and total MET-min) via the International PA Questionnaire - Short Form (IPAQ-SF) [15].
Measured: 2 months
PA Evaluation
PA levels will be measured as a composite measure using smartphone app/accelerometer data (myrecovery.ai; steps per day, light/moderate/vigorous activity, and total MET-min) via the International PA Questionnaire - Short Form (IPAQ-SF) [15].
Measured: 6 months
PA Evaluation
PA levels will be measured as a composite measure using smartphone app/accelerometer data (myrecovery.ai; steps per day, light/moderate/vigorous activity, and total MET-min) via the International PA Questionnaire - Short Form (IPAQ-SF) [15].
Measured: 12 months
Functional Assessment 30 second sit-to-stand test
30 second sit-to-stand test
Measured: Baseline
Functional Assessment 30 second sit-to-stand test
30 second sit-to-stand test
Measured: 2 months
Functional Assessment 30 second sit-to-stand test
30 second sit-to-stand test
Measured: 6 months
Functional Assessment 30 second sit-to-stand test
30 second sit-to-stand test
Measured: 12 months
Functional Assessment 40-meter fast-paced walk test
40-meter fast-paced walk test
Measured: Baseline
Functional Assessment 40-meter fast-paced walk test
40-meter fast-paced walk test
Measured: 2 months
Functional Assessment 40-meter fast-paced walk test
40-meter fast-paced walk test
Measured: 6 months
Functional Assessment 40-meter fast-paced walk test
40-meter fast-paced walk test
Measured: 12 months
Hip Disability and OA Outcome Score (HOOS)
Hip Disability and Osteoarthritis Outcome Score (HOOS) assesses patient pain (10 items), satisfaction including stiffness and range of motion (5 items), activity limitations-daily living (17 items), sports and recreation function (4 items), and hip related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms. This is a patient reported joint-specific score, which may be useful for assessing changes in hip pathology over time, with or without treatment.
Measured: Baseline
Hip Disability and OA Outcome Score (HOOS)
Hip Disability and Osteoarthritis Outcome Score (HOOS) assesses patient pain (10 items), satisfaction including stiffness and range of motion (5 items), activity limitations-daily living (17 items), sports and recreation function (4 items), and hip related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms. This is a patient reported joint-specific score, which may be useful for assessing changes in hip pathology over time, with or without treatment.
Measured: 2 months
Hip Disability and OA Outcome Score (HOOS)
Hip Disability and Osteoarthritis Outcome Score (HOOS) assesses patient pain (10 items), satisfaction including stiffness and range of motion (5 items), activity limitations-daily living (17 items), sports and recreation function (4 items), and hip related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms. This is a patient reported joint-specific score, which may be useful for assessing changes in hip pathology over time, with or without treatment.
Measured: 6 months
Hip Disability and OA Outcome Score (HOOS)
Hip Disability and Osteoarthritis Outcome Score (HOOS) assesses patient pain (10 items), satisfaction including stiffness and range of motion (5 items), activity limitations-daily living (17 items), sports and recreation function (4 items), and hip related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms. This is a patient reported joint-specific score, which may be useful for assessing changes in hip pathology over time, with or without treatment.
Measured: 12 months
Knee OA Outcome Score (KOOS)
Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.
Measured: Baseline
Knee OA Outcome Score (KOOS)
Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.
Measured: 2 months
Knee OA Outcome Score (KOOS)
Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.
Measured: 6 months
Knee OA Outcome Score (KOOS)
Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.
Measured: 12 months
Intermittent and Constant OA Pain (ICOAP)
This 11-item tool is designed to assess pain in individuals with hip or knee osteoarthritis taking into account both constant and intermittent pain experiences. There are two versions of this tool; one to assess pain in the knee joint and another assessing pain in the hip joint.
Measured: Baseline
Intermittent and Constant OA Pain (ICOAP)
This 11-item tool is designed to assess pain in individuals with hip or knee osteoarthritis taking into account both constant and intermittent pain experiences. There are two versions of this tool; one to assess pain in the knee joint and another assessing pain in the hip joint.
Measured: 2 months
Intermittent and Constant OA Pain (ICOAP)
This 11-item tool is designed to assess pain in individuals with hip or knee osteoarthritis taking into account both constant and intermittent pain experiences. There are two versions of this tool; one to assess pain in the knee joint and another assessing pain in the hip joint.
Measured: 6 months
Intermittent and Constant OA Pain (ICOAP)
This 11-item tool is designed to assess pain in individuals with hip or knee osteoarthritis taking into account both constant and intermittent pain experiences. There are two versions of this tool; one to assess pain in the knee joint and another assessing pain in the hip joint.
Measured: 12 months
Patient Global Assessment of Health Status (PGA)
Patient global assessment (PGA) is one of the most widely used PROs in RA practice and research and is included in several composite scores such as the 28-joint Disease Activity Score (DAS28). PGA is often assessed by a single question with a 0-10 or 0-100 response.
Measured: Baseline
Patient Global Assessment of Health Status (PGA)
Patient global assessment (PGA) is one of the most widely used PROs in RA practice and research and is included in several composite scores such as the 28-joint Disease Activity Score (DAS28). PGA is often assessed by a single question with a 0-10 or 0-100 response.
Measured: 2 months
Patient Global Assessment of Health Status (PGA)
Patient global assessment (PGA) is one of the most widely used PROs in RA practice and research and is included in several composite scores such as the 28-joint Disease Activity Score (DAS28). PGA is often assessed by a single question with a 0-10 or 0-100 response.
Measured: 6 months
Patient Global Assessment of Health Status (PGA)
Patient global assessment (PGA) is one of the most widely used PROs in RA practice and research and is included in several composite scores such as the 28-joint Disease Activity Score (DAS28). PGA is often assessed by a single question with a 0-10 or 0-100 response.
Measured: 12 months
Patient Acceptable Symptom State (PASS)
Patient Acceptable Symptom State (PASS) has been defined as the highest level of symptom beyond which patients consider themselves well.
Measured: Baseline
Patient Acceptable Symptom State (PASS)
Patient Acceptable Symptom State (PASS) has been defined as the highest level of symptom beyond which patients consider themselves well.
Measured: 2 months
Patient Acceptable Symptom State (PASS)
Patient Acceptable Symptom State (PASS) has been defined as the highest level of symptom beyond which patients consider themselves well.
Measured: 6 months
Patient Acceptable Symptom State (PASS)
Patient Acceptable Symptom State (PASS) has been defined as the highest level of symptom beyond which patients consider themselves well.
Measured: 12 months
Arthritis Self-Efficacy Questionnaire
The ASES was developed to measure patients' arthritis-specific self-efficacy, or patients' beliefs that they could perform specific tasks or behaviors to cope with the consequences of arthritis.
Measured: Baseline
Arthritis Self-Efficacy Questionnaire
The ASES was developed to measure patients' arthritis-specific self-efficacy, or patients' beliefs that they could perform specific tasks or behaviors to cope with the consequences of arthritis.
Measured: 2 months
Arthritis Self-Efficacy Questionnaire
The ASES was developed to measure patients' arthritis-specific self-efficacy, or patients' beliefs that they could perform specific tasks or behaviors to cope with the consequences of arthritis.
Measured: 6 months
Arthritis Self-Efficacy Questionnaire
The ASES was developed to measure patients' arthritis-specific self-efficacy, or patients' beliefs that they could perform specific tasks or behaviors to cope with the consequences of arthritis.
Measured: 12 months
Center for the Epidemiological studies - Depression Scale (CES-D)
The Center for Epidemiologic Studies Depression Scale is a commonly used freely available self-report measure of depressive symptoms.
Measured: Baseline
Center for the Epidemiological studies - Depression Scale (CES-D)
The Center for Epidemiologic Studies Depression Scale is a commonly used freely available self-report measure of depressive symptoms.
Measured: 2 months
Center for the Epidemiological studies - Depression Scale (CES-D)
The Center for Epidemiologic Studies Depression Scale is a commonly used freely available self-report measure of depressive symptoms.
Measured: 6 months
Center for the Epidemiological studies - Depression Scale (CES-D)
The Center for Epidemiologic Studies Depression Scale is a commonly used freely available self-report measure of depressive symptoms.
Measured: 12 months
Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
The scale consists of 18 items relating to the subjective experience of fatigue. Each item asks respondents to place an "X," representing how they currently feel, along a visual analogue line that extends between two extremes (e.g., from "not at all tired" to "extremely tired").
Measured: Baseline
Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
The scale consists of 18 items relating to the subjective experience of fatigue. Each item asks respondents to place an "X," representing how they currently feel, along a visual analogue line that extends between two extremes (e.g., from "not at all tired" to "extremely tired").
Measured: 2 months
Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
The scale consists of 18 items relating to the subjective experience of fatigue. Each item asks respondents to place an "X," representing how they currently feel, along a visual analogue line that extends between two extremes (e.g., from "not at all tired" to "extremely tired").
Measured: 6 months
Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
The scale consists of 18 items relating to the subjective experience of fatigue. Each item asks respondents to place an "X," representing how they currently feel, along a visual analogue line that extends between two extremes (e.g., from "not at all tired" to "extremely tired").
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start18 Jun 2021
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jane Thornton, MD PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544904
- Sponsor's protocol ID
- 2020TEAM
- Acronym
- TEAM
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2020
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bombardier, C., G. Hawker, and D. Mosher, The Impact of Arthritis in Canada: Today and Over the Next 30 Years. 2011, Arthritis Alliance of Canada: Canadian Arthritis Network.
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.
PubMed 24462672King LK, Marshall DA, Faris P, Woodhouse LJ, Jones CA, Noseworthy T, Bohm E, Dunbar MJ, Hawker GA; BEST-Knee Research Team. Use of Recommended Non-surgical Knee Osteoarthritis Management in Patients prior to Total Knee Arthroplasty: A Cross-sectional Study. J Rheumatol. 2020 Aug 1;47(8):1253-1260. doi: 10.3899/jrheum.190467. Epub 2019 Nov 15.
PubMed 31732554Malian, S.J., Predictors of appropriate referral to total knee arthroplasty: a validation study, in Health and Rehabilitation Sciences. 2015, Western University: Electronic Thesis and Dissertation Repository. p. 75.
Churchill L, Malian SJ, Chesworth BM, Bryant D, MacDonald SJ, Marsh JD, Giffin JR. The development and validation of a multivariable model to predict whether patients referred for total knee replacement are suitable surgical candidates at the time of initial consultation. Can J Surg. 2016 Dec;59(6):407-414. doi: 10.1503/cjs.004316.
PubMed 28234616Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581.
PubMed 26606383Lewis BS, Lynch WD. The effect of physician advice on exercise behavior. Prev Med. 1993 Jan;22(1):110-21. doi: 10.1006/pmed.1993.1008.
PubMed 8475007Andersen RE, Blair SN, Cheskin LJ, Bartlett SJ. Encouraging patients to become more physically active: the physician's role. Ann Intern Med. 1997 Sep 1;127(5):395-400. doi: 10.7326/0003-4819-127-5-199709010-00010. No abstract available.
PubMed 9273831Flores Mateo G, Granado-Font E, Ferre-Grau C, Montana-Carreras X. Mobile Phone Apps to Promote Weight Loss and Increase Physical Activity: A Systematic Review and Meta-Analysis. J Med Internet Res. 2015 Nov 10;17(11):e253. doi: 10.2196/jmir.4836.
PubMed 26554314Skou 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.
PubMed 23290290Skou 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.
PubMed 25123117Skou ST, Roos EM. Good Life with osteoArthritis in Denmark (GLA:D): evidence-based education and supervised neuromuscular exercise delivered by certified physiotherapists nationwide. BMC Musculoskelet Disord. 2017 Feb 7;18(1):72. doi: 10.1186/s12891-017-1439-y.
PubMed 28173795Maksymowych WP, Richardson R, Mallon C, van der Heijde D, Boonen A. Evaluation and validation of the patient acceptable symptom state (PASS) in patients with ankylosing spondylitis. Arthritis Rheum. 2007 Feb 15;57(1):133-9. doi: 10.1002/art.22469.
PubMed 17266072Agarwal P, Kithulegoda N, Bouck Z, Bosiak B, Birnbaum I, Reddeman L, Steiner L, Altman L, Mawson R, Propp R, Thornton J, Ivers N. Feasibility of an Electronic Health Tool to Promote Physical Activity in Primary Care: Pilot Cluster Randomized Controlled Trial. J Med Internet Res. 2020 Feb 14;22(2):e15424. doi: 10.2196/15424.
PubMed 32130122Keating XD, Zhou K, Liu X, Hodges M, Liu J, Guan J, Phelps A, Castro-Pinero J. Reliability and Concurrent Validity of Global Physical Activity Questionnaire (GPAQ): A Systematic Review. Int J Environ Res Public Health. 2019 Oct 26;16(21):4128. doi: 10.3390/ijerph16214128.
PubMed 31717742
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Uses of Technology for Individuals With Mild to Moderate Hip or Knee Osteoarthritis: The Technology, Exercise Programming, and Activity Prescription for Enhanced Mobility (TEAM) Study
- ClinicalTrials.gov ID
- NCT04544904
- Acronym / sponsor ID
- TEAM / 2020TEAM
- Conditions
- Osteo Arthritis Knee, Osteoarthritis, Hip Arthritis
- Keywords
- exercise, physical activity, medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 10 Sep 2020 (actual)
- 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.
Many individuals with osteoarthritis (OA) (up to 45%) are referred to an orthopaedic surgeon for a joint replacement prematurely or will not be candidates for surgery. These individuals need appropriate (non-operative) care to help reduce their pain and enhance their mobility. We are studying the use of innovative technology to help physicians give physical activity advice for patients to become more active and provide free online resources to help patients understand OA self-management and exercise, especially when they have barriers to accessing formal care. Individuals with OA that are referred to a specialized clinic will receive one of three interventions: usual care (handout on resources), a physical activity prescription by a doctor, or the prescription and a link to a free web-based platform (website) on non-operative management of OA with patient education and exercise videos. Our goal is to help with non-operative management strategies to improve quality of life, reduce pain, improve mobility, and possibly delay or prevent a joint replacement.
Osteoarthritis is a condition where people feel joint pain or stiffness. Joints are the body parts where two bones join together with softer material (cartilage) between them. In osteoarthritis, this cartilage wears down. It is the biggest cause for disability worldwide. Helping people with osteoarthritis starts with education, physical activity, and physiotherapy. Doctors can also prescribe braces, injections or medications. For severe osteoarthritis when nothing else helps, surgery can be done to replace the joint.
Doctors often refer patients for surgery too soon. Skipping steps of care may mean unnecessary surgery and longer wait times. The Musculoskeletal Rapid Access Clinic (now called Clinic) in London was set up to solve these problems. They screen patients before referring them to a surgeon, and do not refer almost half of patients. Our goal is to support these patients with new ways to make their non-surgical treatment better.
The first way is through physical activity 'prescription'. It works well for other chronic conditions and patients say it helps. We don't know how well it works for people with osteoarthritis. Most doctors have little time, training or experience for prescribing physical activity. Technology can make it easier for doctors and patients. We have designed a tool to help doctors prescribe physical activity and a smartphone app to track patient activity. We have also created a free website. This includes patient education, exercise videos, and virtual physiotherapy. This can be important for individuals who can't access in-person care.
Detailed description
Osteoarthritis (OA) is the leading cause of disability worldwide and affects more than 4.4 million Canadians. Current evidence-based guidelines for OA management recommend weight management, patient education, physical activity, physiotherapy (PT), bracing, viscosupplementation, and anti-inflammatory/pain medications prior to joint replacement surgery. Unfortunately, current practice trends are not consistent with these guidelines, as nearly half of patients with OA referred to orthopedic surgeons do not require total joint arthroplasty (TJA) at the time of initial consultation. Through the Southwest Musculoskeletal Rapid Access Clinic (RAC), approximately ten referrals (20%) are rejected each day due to OA criteria not met, and a further 20% are assessed as non-operative.
We aim to identify individuals with 'mild to moderate' OA and optimize their first-line non-operative management, starting with physical activity and education.
Physical activity prescriptions are effective in increasing patient levels of physical activity, and 93% of patients surveyed want advice on physical activity from their physicians; but it is underused.
Physicians cite lack of time and inadequate training as barriers. Electronic screening of physical activity behaviours can save time for physicians, and the use of digital health tools can improve physical activity levels.
Patient education and physiotherapist-led group exercise therapy programs have shown to delay progression of knee OA symptoms and improve pain and function; however, two of the most significant barriers to accessing exercise programming is the cost (~approximate $425-475 per 6-8-week session) and accessibility to attend the exercise session (proximity to facility, remote/rural communities, etc.).
The Need for a Solution that targets both Providers and Patients Screening for baseline physical activity levels and including educational components significantly increase intervention effectiveness.
We have previously tested the feasibility of implementing an e-health tool to support physical activity counselling by physicians during patients' periodic health review. We will adapt and implement this tool, Physical Activity and App Prescription (PARx) to screen and provide tailored resources for physical activity in the setting of OA. We will use tablet computers and email, directly linked with the electronic medical record (EMR), to engage patients in contemplating their own physical activity levels, start conversations with their healthcare providers (in this case, primary care physicians with additional training in sport and exercise medicine), and support customized, patient-centered health care. After patients enter their information, they will receive evidence-based behavioural change supports to help them meet their goals.
The automated algorithm assesses current activity level, risk factors/comorbidities and readiness for change. Based on the answers provided, patients are risk-stratified and tailored resources will be provided to the patient and to their clinician in the form of decision support tools embedded in the EMR. This will include the novel implementation of an exercise tracking platform via the smartphone app (myrecovery.ai).
The web-based platform Joint Management (JM) is a free, readily accessible evidenced-based resource focusing on non-operative management strategies for mild to moderate hip and knee OA. The platform will include exercise programming (videos, pictures, and descriptions of the exercises) and patient education (benefits of exercise, lifestyle modifications, nutrition, injections, etc.), to assist the patient engage in self-management. JM will also include the option for (paid) virtual access to PTs, who can provide individualized support, recommendations and exercise programming via the platform.
RATIONALE:
Creating customized physical activity plans with automated reminders and other supports addresses the problem of self-efficacy in providers by developing an evidence-based automated method, while also addressing the issue of patient adherence by using tailored behaviour change techniques, through assessing readiness for change, and helping patients create new habits.
The motivation for JM is to create a free, online evidence-based OA education and exercise programming resource for those that are not able to afford or access community-based exercise programs. The virtual PT option will help optimize patient's experience with the web-based platform, offering support and personalized recommendations regarding management of their condition and exercise programming tailored to their specific abilities, preferences, and needs.
Why this is Innovative:
The evidence for using patient-reported measures and functional outcomes to guide quality improvement for personalized OA care in a systematic manner is in an early stage, meaning that this project can not only impact healthcare delivery and translate new knowledge into medical practice but help position Western University as a leader in this area. The novel technologies (PARx and JM) are innovative tools informed by patient priorities and co-designed with our patient partners, specifically geared towards 1) developing new and more personalized treatment approaches, 2) developing more effective self-management tools, and 3) reducing disparities in vulnerable and hard-to-reach populations. To this end, we will share our findings broadly with our patient partners and reach out to these harder-to-reach groups in particular.
EXPECTED OUTCOMES:
Health Outcomes: We expect to increase patients' physical activity and improve outcomes for individuals with mild to moderate OA. We aim to optimize non-operative management of OA symptoms and therefore possibly delay and/or prevent the need for TJA.
Academic Outcomes: We expect to develop a model of physical activity prescription and patient education that can be scaled up for implementation in primary care.
Societal Outcomes: Both novel technologies have the potential to be implemented across Canada, targeting modifying disease progression and, ideally, delaying or preventing TJA.
Innovative Technology 1: Physical Activity (PA) and App Prescription (Rx) (PARx) Physical Activity and App Prescription (PARx): Tablet/email software (REDCap) is used to collect physical activity data from patient input and prompt intervention by providers. The automated algorithm assesses current activity level, risk factors/comorbidities and readiness for change. Based upon their answers, patients will be risk-stratified and tailored resources will be provided to them in the form of a personalized prescription and free smartphone app (myrecovery.ai) to track activity levels.
Innovative Technology 2: Joint Management (JM) Joint Management (JM): This is a free online evidence-based OA education and exercise programming resource for those that are not able to afford or access community-based exercise programs, with a virtual physiotherapy (PT) option to offer support and personalized recommendations.
OBJECTIVES:
The objective of the proposed study is to 1) determine if PARx and JM will improve pain, increase physical activity levels, and improve functional outcomes in patients with mild to moderate hip or knee OA
RESEARCH QUESTIONS:
- Does the use of novel technology (PARx) affect patient reported outcomes in individuals with mild to moderate hip or knee OA?
- Does PARx influence activity levels in individuals with mild to moderate hip or knee OA?
- Does the use of novel technology (PARx and JM) affect patient reported and functional outcomes in individuals with mild to moderate hip or knee OA?
- What are the experiences and perceptions of patients and physicians during this process?
SPECIFIC AIMS:
Measure and compare A1) patient reported outcomes (pain, joint stiffness, disability, quality of life, disease knowledge, self-efficacy, depression, and fatigue), A2) physical activity levels, and A3) functional outcomes with those that have access (PARx and JM) and those that do not have access (usual care) to the technology. Determine A4) participant and physician experiences.
HYPOTHESES:
We hypothesize that access to technology-facilitated physical activity prescription (PARx) and access to the web-based platform (JM) will H1) improve patient reported outcomes (pain, joint stiffness, disability, quality of life, disease knowledge, self-efficacy, depression, and fatigue), H2) increase PA levels, and H3) improve functional outcomes in individuals with mild to moderate hip or knee OA compared to usual care. We hypothesize that access to JM will result in a greater improvement than PARx alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients will receive the usual care. |
| PAARx | Experimental | Device: PAARxPatients will be prescribed technology-based physical activity programming. |
| PAARx and JM | Experimental | Device: PAARx, Device: JMPatients will be prescribed technology-based physical activity programming and be referred to a web-based resource for evidence-based joint management. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 40-74 years of age
- Screened by the Southwest Musculoskeletal RAC as "mild to moderate OA" using clinical and radiographic criteria
Key exclusion criteria (6 listed)
- Concomitant end-stage OA (awaiting/prior TJA)
- Inflammatory arthritis (rheumatoid, psoriatic, or disease-modifying anti-rheumatic drug exposure)
- Unstable medical conditions that would preclude physical activity prescription (e.g. unstable angina, uncontrolled Type 2 Diabetes)
- Not able/willing to follow up for the study period
- Does not have access to the internet
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 |
|---|---|---|
| PAARxPrescription Physical Activity Programming Application | Device | PAARx, PAARx and JM |
| JMJoint Management (JM) web-based joint management resource. | Device | PAARx and JM |
Primary outcome
height
Time frame: Baseline
height in cm
height
Time frame: 2 months
height in cm
height
Time frame: 6 months
height in cm
height
Time frame: 12 months
height in cm
body mass index (derived)
Time frame: Baseline
body mass index as calculated with height and weight
body mass index (derived)
Time frame: 2 months
body mass index as calculated with height and weight
body mass index (derived)
Time frame: 6 months
body mass index as calculated with height and weight
body mass index (derived)
Time frame: 12 months
body mass index as calculated with height and weight
abdominal circumference
Time frame: Baseline
abdominal circumference in cm
abdominal circumference
Time frame: 2 months
abdominal circumference in cm
abdominal circumference
Time frame: 6 months
abdominal circumference in cm
abdominal circumference
Time frame: 12 months
abdominal circumference in cm
weight
Time frame: Baseline
weight kg , weight, body mass index (derived), abdominal circumference, and medical history to assess for comorbid disease.
weight
Time frame: 2 months
weight kg , weight, body mass index (derived), abdominal circumference, and medical history to assess for comorbid disease.
weight
Time frame: 6 months
weight kg , weight, body mass index (derived), abdominal circumference, and medical history to assess for comorbid disease.
weight
Time frame: 12 months
weight kg , weight, body mass index (derived), abdominal circumference, and medical history to assess for comorbid disease.
PA Evaluation
Time frame: Baseline
PA levels will be measured as a composite measure using smartphone app/accelerometer data (myrecovery.ai; steps per day, light/moderate/vigorous activity, and total MET-min) via the International PA Questionnaire - Short Form (IPAQ-SF) [15].
PA Evaluation
Time frame: 2 months
PA levels will be measured as a composite measure using smartphone app/accelerometer data (myrecovery.ai; steps per day, light/moderate/vigorous activity, and total MET-min) via the International PA Questionnaire - Short Form (IPAQ-SF) [15].
PA Evaluation
Time frame: 6 months
PA levels will be measured as a composite measure using smartphone app/accelerometer data (myrecovery.ai; steps per day, light/moderate/vigorous activity, and total MET-min) via the International PA Questionnaire - Short Form (IPAQ-SF) [15].
PA Evaluation
Time frame: 12 months
PA levels will be measured as a composite measure using smartphone app/accelerometer data (myrecovery.ai; steps per day, light/moderate/vigorous activity, and total MET-min) via the International PA Questionnaire - Short Form (IPAQ-SF) [15].
Functional Assessment 30 second sit-to-stand test
Time frame: Baseline
30 second sit-to-stand test
Functional Assessment 30 second sit-to-stand test
Time frame: 2 months
30 second sit-to-stand test
Functional Assessment 30 second sit-to-stand test
Time frame: 6 months
30 second sit-to-stand test
Functional Assessment 30 second sit-to-stand test
Time frame: 12 months
30 second sit-to-stand test
Functional Assessment 40-meter fast-paced walk test
Time frame: Baseline
40-meter fast-paced walk test
Functional Assessment 40-meter fast-paced walk test
Time frame: 2 months
40-meter fast-paced walk test
Functional Assessment 40-meter fast-paced walk test
Time frame: 6 months
40-meter fast-paced walk test
Functional Assessment 40-meter fast-paced walk test
Time frame: 12 months
40-meter fast-paced walk test
Hip Disability and OA Outcome Score (HOOS)
Time frame: Baseline
Hip Disability and Osteoarthritis Outcome Score (HOOS) assesses patient pain (10 items), satisfaction including stiffness and range of motion (5 items), activity limitations-daily living (17 items), sports and recreation function (4 items), and hip related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms. This is a patient reported joint-specific score, which may be useful for assessing changes in hip pathology over time, with or without treatment.
Hip Disability and OA Outcome Score (HOOS)
Time frame: 2 months
Hip Disability and Osteoarthritis Outcome Score (HOOS) assesses patient pain (10 items), satisfaction including stiffness and range of motion (5 items), activity limitations-daily living (17 items), sports and recreation function (4 items), and hip related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms. This is a patient reported joint-specific score, which may be useful for assessing changes in hip pathology over time, with or without treatment.
Hip Disability and OA Outcome Score (HOOS)
Time frame: 6 months
Hip Disability and Osteoarthritis Outcome Score (HOOS) assesses patient pain (10 items), satisfaction including stiffness and range of motion (5 items), activity limitations-daily living (17 items), sports and recreation function (4 items), and hip related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms. This is a patient reported joint-specific score, which may be useful for assessing changes in hip pathology over time, with or without treatment.
Hip Disability and OA Outcome Score (HOOS)
Time frame: 12 months
Hip Disability and Osteoarthritis Outcome Score (HOOS) assesses patient pain (10 items), satisfaction including stiffness and range of motion (5 items), activity limitations-daily living (17 items), sports and recreation function (4 items), and hip related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms. This is a patient reported joint-specific score, which may be useful for assessing changes in hip pathology over time, with or without treatment.
Knee OA Outcome Score (KOOS)
Time frame: Baseline
Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.
Knee OA Outcome Score (KOOS)
Time frame: 2 months
Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.
Knee OA Outcome Score (KOOS)
Time frame: 6 months
Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.
Knee OA Outcome Score (KOOS)
Time frame: 12 months
Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.
Intermittent and Constant OA Pain (ICOAP)
Time frame: Baseline
This 11-item tool is designed to assess pain in individuals with hip or knee osteoarthritis taking into account both constant and intermittent pain experiences. There are two versions of this tool; one to assess pain in the knee joint and another assessing pain in the hip joint.
Intermittent and Constant OA Pain (ICOAP)
Time frame: 2 months
This 11-item tool is designed to assess pain in individuals with hip or knee osteoarthritis taking into account both constant and intermittent pain experiences. There are two versions of this tool; one to assess pain in the knee joint and another assessing pain in the hip joint.
Intermittent and Constant OA Pain (ICOAP)
Time frame: 6 months
This 11-item tool is designed to assess pain in individuals with hip or knee osteoarthritis taking into account both constant and intermittent pain experiences. There are two versions of this tool; one to assess pain in the knee joint and another assessing pain in the hip joint.
Intermittent and Constant OA Pain (ICOAP)
Time frame: 12 months
This 11-item tool is designed to assess pain in individuals with hip or knee osteoarthritis taking into account both constant and intermittent pain experiences. There are two versions of this tool; one to assess pain in the knee joint and another assessing pain in the hip joint.
Patient Global Assessment of Health Status (PGA)
Time frame: Baseline
Patient global assessment (PGA) is one of the most widely used PROs in RA practice and research and is included in several composite scores such as the 28-joint Disease Activity Score (DAS28). PGA is often assessed by a single question with a 0-10 or 0-100 response.
Patient Global Assessment of Health Status (PGA)
Time frame: 2 months
Patient global assessment (PGA) is one of the most widely used PROs in RA practice and research and is included in several composite scores such as the 28-joint Disease Activity Score (DAS28). PGA is often assessed by a single question with a 0-10 or 0-100 response.
Patient Global Assessment of Health Status (PGA)
Time frame: 6 months
Patient global assessment (PGA) is one of the most widely used PROs in RA practice and research and is included in several composite scores such as the 28-joint Disease Activity Score (DAS28). PGA is often assessed by a single question with a 0-10 or 0-100 response.
Patient Global Assessment of Health Status (PGA)
Time frame: 12 months
Patient global assessment (PGA) is one of the most widely used PROs in RA practice and research and is included in several composite scores such as the 28-joint Disease Activity Score (DAS28). PGA is often assessed by a single question with a 0-10 or 0-100 response.
Patient Acceptable Symptom State (PASS)
Time frame: Baseline
Patient Acceptable Symptom State (PASS) has been defined as the highest level of symptom beyond which patients consider themselves well.
Patient Acceptable Symptom State (PASS)
Time frame: 2 months
Patient Acceptable Symptom State (PASS) has been defined as the highest level of symptom beyond which patients consider themselves well.
Patient Acceptable Symptom State (PASS)
Time frame: 6 months
Patient Acceptable Symptom State (PASS) has been defined as the highest level of symptom beyond which patients consider themselves well.
Patient Acceptable Symptom State (PASS)
Time frame: 12 months
Patient Acceptable Symptom State (PASS) has been defined as the highest level of symptom beyond which patients consider themselves well.
Arthritis Self-Efficacy Questionnaire
Time frame: Baseline
The ASES was developed to measure patients' arthritis-specific self-efficacy, or patients' beliefs that they could perform specific tasks or behaviors to cope with the consequences of arthritis.
Arthritis Self-Efficacy Questionnaire
Time frame: 2 months
The ASES was developed to measure patients' arthritis-specific self-efficacy, or patients' beliefs that they could perform specific tasks or behaviors to cope with the consequences of arthritis.
Arthritis Self-Efficacy Questionnaire
Time frame: 6 months
The ASES was developed to measure patients' arthritis-specific self-efficacy, or patients' beliefs that they could perform specific tasks or behaviors to cope with the consequences of arthritis.
Arthritis Self-Efficacy Questionnaire
Time frame: 12 months
The ASES was developed to measure patients' arthritis-specific self-efficacy, or patients' beliefs that they could perform specific tasks or behaviors to cope with the consequences of arthritis.
Center for the Epidemiological studies - Depression Scale (CES-D)
Time frame: Baseline
The Center for Epidemiologic Studies Depression Scale is a commonly used freely available self-report measure of depressive symptoms.
Center for the Epidemiological studies - Depression Scale (CES-D)
Time frame: 2 months
The Center for Epidemiologic Studies Depression Scale is a commonly used freely available self-report measure of depressive symptoms.
Center for the Epidemiological studies - Depression Scale (CES-D)
Time frame: 6 months
The Center for Epidemiologic Studies Depression Scale is a commonly used freely available self-report measure of depressive symptoms.
Center for the Epidemiological studies - Depression Scale (CES-D)
Time frame: 12 months
The Center for Epidemiologic Studies Depression Scale is a commonly used freely available self-report measure of depressive symptoms.
Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
Time frame: Baseline
The scale consists of 18 items relating to the subjective experience of fatigue. Each item asks respondents to place an "X," representing how they currently feel, along a visual analogue line that extends between two extremes (e.g., from "not at all tired" to "extremely tired").
Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
Time frame: 2 months
The scale consists of 18 items relating to the subjective experience of fatigue. Each item asks respondents to place an "X," representing how they currently feel, along a visual analogue line that extends between two extremes (e.g., from "not at all tired" to "extremely tired").
Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
Time frame: 6 months
The scale consists of 18 items relating to the subjective experience of fatigue. Each item asks respondents to place an "X," representing how they currently feel, along a visual analogue line that extends between two extremes (e.g., from "not at all tired" to "extremely tired").
Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
Time frame: 12 months
The scale consists of 18 items relating to the subjective experience of fatigue. Each item asks respondents to place an "X," representing how they currently feel, along a visual analogue line that extends between two extremes (e.g., from "not at all tired" to "extremely tired").
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 31 Aug 2026.
- BackgroundBombardier, C., G. Hawker, and D. Mosher, The Impact of Arthritis in Canada: Today and Over the Next 30 Years. 2011, Arthritis Alliance of Canada: Canadian Arthritis Network.
- 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 31732554King LK, Marshall DA, Faris P, Woodhouse LJ, Jones CA, Noseworthy T, Bohm E, Dunbar MJ, Hawker GA; BEST-Knee Research Team. Use of Recommended Non-surgical Knee Osteoarthritis Management in Patients prior to Total Knee Arthroplasty: A Cross-sectional Study. J Rheumatol. 2020 Aug 1;47(8):1253-1260. doi: 10.3899/jrheum.190467. Epub 2019 Nov 15.
- BackgroundMalian, S.J., Predictors of appropriate referral to total knee arthroplasty: a validation study, in Health and Rehabilitation Sciences. 2015, Western University: Electronic Thesis and Dissertation Repository. p. 75.
- Background: PubMed 28234616Churchill L, Malian SJ, Chesworth BM, Bryant D, MacDonald SJ, Marsh JD, Giffin JR. The development and validation of a multivariable model to predict whether patients referred for total knee replacement are suitable surgical candidates at the time of initial consultation. Can J Surg. 2016 Dec;59(6):407-414. doi: 10.1503/cjs.004316.
- Background: PubMed 26606383Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581.
- Background: PubMed 8475007Lewis BS, Lynch WD. The effect of physician advice on exercise behavior. Prev Med. 1993 Jan;22(1):110-21. doi: 10.1006/pmed.1993.1008.
- Background: PubMed 9273831Andersen RE, Blair SN, Cheskin LJ, Bartlett SJ. Encouraging patients to become more physically active: the physician's role. Ann Intern Med. 1997 Sep 1;127(5):395-400. doi: 10.7326/0003-4819-127-5-199709010-00010. No abstract available.
- Background: PubMed 26554314Flores Mateo G, Granado-Font E, Ferre-Grau C, Montana-Carreras X. Mobile Phone Apps to Promote Weight Loss and Increase Physical Activity: A Systematic Review and Meta-Analysis. J Med Internet Res. 2015 Nov 10;17(11):e253. doi: 10.2196/jmir.4836.
- Background: PubMed 23290290Skou 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.
- Background: PubMed 25123117Skou 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.
- Background: PubMed 28173795Skou ST, Roos EM. Good Life with osteoArthritis in Denmark (GLA:D): evidence-based education and supervised neuromuscular exercise delivered by certified physiotherapists nationwide. BMC Musculoskelet Disord. 2017 Feb 7;18(1):72. doi: 10.1186/s12891-017-1439-y.
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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.
Jane Thornton, MD PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAARx and JM in people with Osteo Arthritis Knee and Osteoarthritis, run by Western University, Canada 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 2 inclusion and 6 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 31 Aug 2026. 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?
height (time frame: Baseline). The study lists 60 primary outcomes in all. 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 NCT04544904, which also lists 28 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 31 Aug 2026.