Technology & Exercise Programming for Osteoarthritis

(TEAM Trial)

Overseen By Stacey Wanlin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Must not be taking: Disease-modifying anti-rheumatics

Disqualifiers: End-stage OA, Inflammatory arthritis, Unstable conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

192 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have inflammatory arthritis or are taking certain arthritis medications, you may not be eligible to participate.

What data supports the effectiveness of the TEAM treatment for osteoarthritis?

Research shows that using technology like apps and wearable devices can help people with osteoarthritis exercise more effectively at home, which can reduce pain and improve movement. Exercise therapy, especially when combined with other physical therapy methods, has been shown to be better than doing nothing for osteoarthritis. ^{1 2 3 4 5}

Is the Technology & Exercise Programming for Osteoarthritis treatment safe for humans?

Research on physical activity interventions, like those in the Behavior Change Consortium, shows that while minor injuries can occur, serious adverse events are rare. The studies emphasize starting with low intensity and gradually increasing, which helps ensure safety. ^{6 7 8 9 10}

How does the TEAM treatment for osteoarthritis differ from other treatments?

The TEAM treatment for osteoarthritis is unique because it combines technology with exercise programming and activity prescription to enhance mobility, using digital tools like smartphone apps to provide real-time feedback and support for rehabilitation exercises at home. This approach allows for remote supervision and personalized exercise correction, which is not commonly available in traditional osteoarthritis treatments. ^{3 11 12 13 14}

Research Team

Jane Thornton, MD PhD

Principal Investigator

Western University

Eligibility Criteria

This study is for people aged 40-74 with mild to moderate osteoarthritis, as determined by a specialized clinic. Participants must be able to follow the study plan and have internet access. It's not for those awaiting or who've had joint replacement surgery, have inflammatory arthritis, unstable medical conditions like uncontrolled diabetes, or can't communicate in English.

Inclusion Criteria

40-74 years of age

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

Exclusion Criteria

Unstable medical conditions that would preclude physical activity prescription (e.g. unstable angina, uncontrolled Type 2 Diabetes)

Cannot communicate in English.

Concomitant end-stage OA (awaiting/prior TJA)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three interventions: usual care, a physical activity prescription, or the prescription with access to a web-based platform for non-operative management of OA

12 months

Regular virtual check-ins via app and email

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may continue using the web-based platform and app for ongoing management and monitoring

Long-term

Treatment Details

Interventions

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

Trial Overview The TEAM Study tests how technology and doctor-prescribed physical activity can help manage osteoarthritis without surgery. Patients will either get usual care resources, a physical activity prescription from their doctor, or both the prescription and access to an educational website with exercise videos.

Participant Groups

Group I: PAARx and JM Experimental Treatment 2 Interventions

Patients will be prescribed technology-based physical activity programming and be referred to a web-based resource for evidence-based joint management.

Group II: PAARx Experimental Treatment 1 Intervention

Patients will be prescribed technology-based physical activity programming.

Group III: Usual Care Active Control 1 Intervention

Patients will receive the usual care.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Findings from Research

In a study of 122 patients with advanced hip osteoarthritis, using a Fitbit to track daily steps revealed an average of 5721 steps per day, indicating a measurable level of physical activity.

There was a significant positive correlation between the number of steps taken and patient-reported outcomes, suggesting that wearable technology can effectively assess physical activity levels and their impact on health in hip OA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation between hip osteoarthritis and the level of physical activity as measured by wearable technology and patient-reported questionnaires. Morcos, MW., Teeter, MG., Somerville, LE., et al.[2022]

The Motion Coach app provides real-time audiovisual feedback on exercise execution for patients with osteoarthritis and shows interrater agreement with physiotherapists that is comparable to evaluations made by two different physiotherapists, indicating its reliability.

In a study involving 24 participants, the Motion Coach app demonstrated noninferior performance in assessing exercise form, suggesting it can effectively support rehabilitation for musculoskeletal disorders without significant differences in accuracy across various age, gender, or BMI subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

App-Based Feedback for Rehabilitation Exercise Correction in Patients With Knee or Hip Osteoarthritis: Prospective Cohort Study. Biebl, JT., Rykala, M., Strobel, M., et al.[2021]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

In a review of 113 randomized controlled trials involving 5909 participants with knee osteoarthritis, only 44.2% reported adverse events (AEs), indicating potential underreporting of exercise-related harm, which was found in 6.0% of participants with clear AE statements.

The study highlighted improvements in reporting AEs and dropouts (DOs) after the implementation of the CONSORT-2010 guidelines, but emphasized the need for clearer definitions and reporting standards to ensure the safety and efficacy of therapeutic exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of Harm in Randomized Controlled Trials of Therapeutic Exercise for Knee Osteoarthritis: A Systematic Review. von Heideken, J., Chowdhry, S., Borg, J., et al.[2023]

A randomized controlled trial involving 40 adults with knee osteoarthritis showed that adding mobilisation with movement to usual care significantly improved disability, pain, and function over six months, with a mean difference of 7.4 points in disability at six months.

Participants receiving mobilisation with movement reported better outcomes in all measured areas, except for knee mobility, indicating that this intervention can enhance overall patient satisfaction and functional abilities in managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term efficacy of mobilisation with movement on pain and functional status in patients with knee osteoarthritis: a randomised clinical trial. Nigam, A., Satpute, KH., Hall, TM.[2022]

References

1. India pubmed.ncbi.nlm.nih.gov

Correlation between hip osteoarthritis and the level of physical activity as measured by wearable technology and patient-reported questionnaires. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Exercise therapy with or without other physical therapy interventions versus placebo interventions for osteoarthritis -Systematic review. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

App-Based Feedback for Rehabilitation Exercise Correction in Patients With Knee or Hip Osteoarthritis: Prospective Cohort Study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of a physical activity counseling intervention using Fitbit in people with knee osteoarthritis: the TRACK-OA study protocol. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Can Physical Therapy Deliver Clinically Meaningful Improvements in Pain and Function Through a Mobile App? An Observational Retrospective Study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Reporting of Harm in Randomized Controlled Trials of Therapeutic Exercise for Knee Osteoarthritis: A Systematic Review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Reporting of Adverse Events in Randomized Controlled Trials of Therapeutic Exercise for Hip Osteoarthritis: A Systematic Review. [2023]

9. England pubmed.ncbi.nlm.nih.gov

The importance of dose in land-based supervised exercise for people with hip osteoarthritis. A systematic review and meta-analysis. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

Patients who underwent total hip or knee arthroplasty are more physically active than the general Dutch population. [2018]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Biomechanics beyond the lab: Remote technology for osteoarthritis patient data-A scoping review. [2022]

12. England pubmed.ncbi.nlm.nih.gov

The use of technology to support lifestyle interventions in knee osteoarthritis: A scoping review. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Long term efficacy of mobilisation with movement on pain and functional status in patients with knee osteoarthritis: a randomised clinical trial. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Use of wearable technology for performance assessment: a validation study. [2019]