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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to discover better methods for managing osteoarthritis without surgery. Researchers are testing technology and exercise programs to help individuals with mild to moderate joint pain enhance mobility and reduce discomfort. Participants will receive one of three treatments: standard care with resource handouts, a doctor's prescription for physical activity, or the prescription plus access to a website with exercise tips and videos. The trial seeks individuals diagnosed with mild to moderate osteoarthritis who have already been screened by a specific clinic. As an unphased trial, it offers participants the chance to contribute to innovative approaches in osteoarthritis management.

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 prior data suggests that this technology and exercise programming is safe for osteoarthritis patients?

Research has shown that technology-based exercise programs are generally safe for people with osteoarthritis (OA). One study found that using apps for exercise was not only safe but also beneficial for OA patients. This suggests that technology can effectively encourage exercise as a way to manage OA.

Other studies support these findings, showing that these programs can significantly reduce knee pain. This indicates that the treatment helps lessen pain without causing harm. Using technology to support exercise appears to be a well-tolerated method for managing OA symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for osteoarthritis because they uniquely combine technology with exercise programming to enhance mobility. Unlike standard care, which often includes medications and physical therapy, these treatments use technology-based activity prescriptions that can be personalized and accessed online. The TEAM approach also leverages a web-based resource for joint management, offering convenient, evidence-based guidance. This innovative use of technology aims to empower patients with tools for better self-management and potentially improved outcomes.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

Research shows that staying active can help manage osteoarthritis (OA) by reducing pain and improving movement. Studies have found that technology, such as apps, effectively encourages physical activity in people with OA. A small trial of a similar app found it easy to use and beneficial for pain and movement. This trial will test different approaches: one group will receive technology-based physical activity programming and access a web-based resource for joint management, while another group will receive only the technology-based physical activity programming. Additionally, learning about OA and doing exercises can slow the condition and improve symptoms. These findings suggest that using technology to support exercise and education could be a helpful non-surgical option for people with OA. ^{1 3 6 7 8}

Who Is on the Research Team?

Jane Thornton, MD PhD

Principal Investigator

Western University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04544904

Study Details | NCT04544904 | The Technology, Exercise ... Patient education and physiotherapist-led group exercise therapy programs have shown to delay progression of knee OA symptoms and improve pain and function; ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5952118/

Efficacy of a Community-Based Technology-Enabled ... We aimed to assess the efficacy of a technology-enabled counseling intervention for improving physical activity in people with either a physician-confirmed ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2665913125000226

Novel uses of healthcare technology for individuals with ... This study will allow us to determine the effectiveness of these interventions on patient-reported outcomes, physical activity levels, and performance-based ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40115196/

Novel uses of healthcare technology for individuals with ... This study will allow us to determine the effectiveness of these interventions on patient-reported outcomes, physical activity levels, and performance-based ...

5. arthritis-research.biomedcentral.com arthritis-research.biomedcentral.com/articles/10.1186/s13075-024-03291-z

Usability and preliminary effectiveness of an app-based ... The control group received usual care. The primary outcomes were usability and preliminary effectiveness (pain and physical functioning).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12454192/

The Effect and Safety of App-Based Interventions for ... This study showed that app-based interventions were safe and effective for patients with OA, which might provide a cost-effective option, ...

7. jmir.org jmir.org/2018/4/e159/

Efficacy of a Community-Based Technology-Enabled ... Outcomes included (1) mean time on moderate-to-vigorous physical activity (MVPA ≥3 metabolic equivalents [METs], primary outcome), (2) mean time ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7883981/

Effects of technology-supported exercise programs on the ... The meta-analysis showed that these programs were associated with significant improvements in knee pain (standardized mean difference [SMD] = − ...