The Technology, Exercise Programming, and Activity Prescription for Enhanced Mobility (TEAM) Study

NCT04544904 | Active Not Recruiting

• 1 other identifier: 2020TEAM
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Osteo Arthritis Knee; Osteoarthritis; Hip Arthritis

Keywords

exercise; physical activity; medicine

Outcome Measures

Primary Outcomes (60)

• height

  height in cm

  Baseline

• height

  height in cm

  2 months

• height

  height in cm

  6 months

• height

  height in cm

  12 months

• body mass index (derived)

  body mass index as calculated with height and weight

  Baseline

• body mass index (derived)

  body mass index as calculated with height and weight

  2 months

• body mass index (derived)

  body mass index as calculated with height and weight

  6 months

• body mass index (derived)

  body mass index as calculated with height and weight

  12 months

• abdominal circumference

  abdominal circumference in cm

  Baseline

• abdominal circumference

  abdominal circumference in cm

  2 months

• abdominal circumference

  abdominal circumference in cm

  6 months

• abdominal circumference

  abdominal circumference in cm

  12 months

• weight

  weight kg , weight, body mass index (derived), abdominal circumference, and medical history to assess for comorbid disease.

  Baseline

• weight

  weight kg , weight, body mass index (derived), abdominal circumference, and medical history to assess for comorbid disease.

  2 months

• weight

  weight kg , weight, body mass index (derived), abdominal circumference, and medical history to assess for comorbid disease.

  6 months

• weight

  weight kg , weight, body mass index (derived), abdominal circumference, and medical history to assess for comorbid disease.

  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) \[15\].

  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) \[15\].

  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) \[15\].

  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) \[15\].

  12 months

• Functional Assessment 30 second sit-to-stand test

  30 second sit-to-stand test

  Baseline

• Functional Assessment 30 second sit-to-stand test

  30 second sit-to-stand test

  2 months

• Functional Assessment 30 second sit-to-stand test

  30 second sit-to-stand test

  6 months

• Functional Assessment 30 second sit-to-stand test

  30 second sit-to-stand test

  12 months

• Functional Assessment 40-meter fast-paced walk test

  40-meter fast-paced walk test

  Baseline

• Functional Assessment 40-meter fast-paced walk test

  40-meter fast-paced walk test

  2 months

• Functional Assessment 40-meter fast-paced walk test

  40-meter fast-paced walk test

  6 months

• Functional Assessment 40-meter fast-paced walk test

  40-meter fast-paced walk test

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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").

  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").

  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").

  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").

  12 months

Study Arms (3)

Usual Care

NO INTERVENTION

Patients will receive the usual care.

PAARx

EXPERIMENTAL

Patients will be prescribed technology-based physical activity programming.

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.

Device: PAARx; Device: JM

Interventions

PAARx DEVICE

Prescription Physical Activity Programming Application

PAARx; PAARx and JM

JM DEVICE

Joint Management (JM) web-based joint management resource.

PAARx and JM

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Screened by the Southwest Musculoskeletal RAC as "mild to moderate OA" using clinical and radiographic criteria

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Fowler Kennedy Sports Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

Related Publications (28)

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  PMID: 40115196 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Jane Thornton, MD PhD

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: September 10, 2020
• Study Start: June 18, 2021
• Primary Completion: June 6, 2025
• Study Completion: June 6, 2025
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

CA (1)