Walk with Ease Program for Osteoarthritis

Overseen By Julie Fritz, PhD, PT

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Utah

Disqualifiers: Inability to walk, Medical contraindication, Language barrier

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help individuals with osteoarthritis (OA) manage their condition through physical activity. It examines various strategies, such as sending text messages and offering physical therapy sessions, to determine which method best supports adherence to a walking program. Participants may receive weekly messages to encourage physical activity or engage in a program called Walk with Ease. This trial is ideal for individuals over 45 who have been diagnosed with OA affecting their legs or spine and have a cellphone for communication. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to a potentially groundbreaking treatment for OA.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a walking program for osteoarthritis.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that text messaging for people with osteoarthritis (OA) is generally well-received. Studies have found that individuals with knee OA can safely use text message programs that promote physical activity. For instance, one study found a mobile messaging program to be safe and practical over six weeks.

Adding motivational messages to these texts does not compromise safety. A small study demonstrated that these motivational texts reduced inactivity without any safety issues.

Regarding the Walk with Ease program, which provides physical activity advice through telehealth, research indicates it is safe for people with arthritis. Earlier studies of this program reported no harmful side effects, meaning participants did not experience negative reactions. Both group and self-directed versions of this program have been tested and are generally considered safe.

In summary, the treatments in this trial—text messaging, motivational messages, and the Walk with Ease program—have a strong safety record based on previous research. Participants in similar programs have not reported major safety issues, offering reassurance to those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for osteoarthritis because they leverage modern technology and personalized engagement to enhance physical activity. Unlike traditional methods that may rely on in-person consultations or medication, this approach uses text messaging to deliver motivational messages and weekly invitations to physical activity counseling, making it highly accessible and convenient. Additionally, the experimental treatment includes enhanced telehealth counseling and self-management resources, along with group classes, providing a comprehensive support system for arthritis management. These innovative methods aim to empower patients and could potentially lead to better adherence and outcomes compared to standard care.

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

Research has shown that text messaging can help people with knee osteoarthritis become more active. In this trial, participants may receive weekly text message invitations for physical activity counseling, with some receiving additional motivational messages. Studies have found that motivational text messages can improve exercise habits and help people maintain their exercise routines.

The Walk with Ease program, created by the Arthritis Foundation, is another treatment option in this trial. It has successfully helped people with arthritis exercise safely and reduce their pain. Participants in this program reported being more physically active and experiencing less pain. This trial will test both the self-directed version and the enhanced version, which includes advice from a physical therapist and group classes, for managing osteoarthritis.

These treatments aim to improve quality of life by encouraging regular exercise, which is essential for managing osteoarthritis. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

The Beat Pain Better Trial is for individuals with osteoarthritis who experience chronic pain. It's designed to help those in communities with less access to treatments. To join, participants must have a diagnosis of osteoarthritis and be interested in managing their pain through physical activity.

Inclusion Criteria

Visit in participating medical clinic within the past 6 months

Has functioning cell phone able to receive calls and texts

I am 45 years old or older.

Exclusion Criteria

Medical contraindication to participation in physical activity

I cannot walk for five minutes, even with help.

I cannot communicate in English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Text Messaging Intervention

Participants receive weekly text message invitations over 4 weeks to engage in physical activity counseling, with or without motivational messages

4 weeks

Physical Activity Counseling

Participants receive six weeks of weekly telehealth physical activity counseling provided by a physical therapist

6 weeks

Walk with Ease Intervention

Participants engage in the Walk with Ease program, either self-directed or enhanced self-directed with group classes

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Text Messaging

Trial Overview This trial tests two main strategies: text messaging and motivational messaging aimed at encouraging physical activity. Participants will receive counseling from physical therapists and engage in the Walk with Ease program to manage their osteoarthritis pain.

How Is the Trial Designed?

Group I: Text Messaging with Motivational Messages Experimental Treatment 2 Interventions

Weekly text message invitations over 4 weeks to engage in physical activity counseling that also include motivational messages

Group II: PA Counseling and Enhanced, Self-Directed Walk with Ease Experimental Treatment 2 Interventions

Six weeks of weekly telehealth PA counseling provided by a physical therapist plus connection to the Walk with Ease portal for ongoing self-management along with opportunity to participate in group classes.

Group III: Text Messaging Active Control 1 Intervention

Weekly text message invitations over 4 weeks to engage in physical activity counseling

Group IV: PA Counseling and Self-Directed Walk with Ease Active Control 1 Intervention

Six weeks of weekly telehealth PA counseling provided by a physical therapist plus connection to the Walk with Ease portal for ongoing self-management.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

A study involving 305 participants with musculoskeletal conditions found that a web-based exercise programming system significantly improved adherence to home exercise programs compared to traditional methods, with notable differences in overall adherence and specific exercise metrics.

Participants using the web-based system reported greater confidence in their ability to perform prescribed exercises, although both groups had similar satisfaction levels with the exercise delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does a Web-Based Exercise Programming System Improve Home Exercise Adherence for People With Musculoskeletal Conditions?: A Randomized Controlled Trial. Bennell, KL., Marshall, CJ., Dobson, F., et al.[2020]

A digital management program for hip and knee osteoarthritis, which included education, exercises, and access to a physical therapist, was positively received by 19 participants, highlighting its flexibility and ease of access compared to traditional care.

Key benefits of the program included no waiting lists, the ability to participate from various locations at convenient times, and daily support from a physical therapist, making it a valid alternative for managing osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'I would never have done it if it hadn't been digital': a qualitative study on patients' experiences of a digital management programme for hip and knee osteoarthritis in Sweden. Cronström, A., Dahlberg, LE., Nero, H., et al.[2020]

Patients who participated in telehealth for knee osteoarthritis found it to be easy, convenient, and flexible, leading to a positive perception of its acceptability, especially among those with prior exposure to telehealth.

Both telehealth and in-person participants reported similar benefits from the GLA:D® program, including reduced fear of pain, improved beliefs about exercise, and enhancements in pain and function, suggesting that telehealth can effectively provide high-quality care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Much better than I thought it was going to be": Telehealth delivered group-based education and exercise was perceived as acceptable among people with knee osteoarthritis. Ezzat, AM., Bell, E., Kemp, JL., et al.[2022]

A systematic review of 12 studies involving text messaging interventions for behavior change found that 8 out of 9 sufficiently powered studies supported its effectiveness in promoting health behavior changes over periods ranging from 3 to 12 months.

The review highlighted the need for more research in developing countries, as most studies were conducted in developed nations, despite the potential for text messaging to be a low-cost health intervention globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text messaging as a tool for behavior change in disease prevention and management. Cole-Lewis, H., Kershaw, T.[2022]

The revised 6-week Walk With Ease (WWE) program significantly improved self-reported outcomes and performance measures in adults with arthritis, showing benefits in disability, pain, fatigue, and strength, with no reported adverse events.

Both instructor-led and self-directed formats of the WWE program were effective, with self-directed participants maintaining more significant improvements in certain outcomes at the 1-year mark, highlighting the program's safety and accessibility for promoting physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of group and self-directed formats of the Arthritis Foundation's Walk With Ease Program. Callahan, LF., Shreffler, JH., Altpeter, M., et al.[2011]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10206185/

Walk with ease for knee osteoarthritis: A cost-effectiveness ... The Walk With Ease (WWE) program was developed by the Arthritis Foundation to help people with arthritis learn to exercise safely and improve arthritis ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06932887

Study Details | NCT06932887 | The Beat Pain Better Trial Six weeks of weekly telehealth PA counseling provided by a physical therapist plus connection to the Walk with Ease portal for ongoing self-management.

3. withpower.com withpower.com/trial/walk-with-ease-program-for-osteoarthritis-c5d93

Walk with Ease Program for Osteoarthritis · Info for Participants Both instructor-led and self-directed formats of the WWE program were effective, with self-directed participants maintaining more significant improvements in ...

4. trials.arthritis.org trials.arthritis.org/trials/NCT06932887

The Beat Pain Better Trial - Arthritis Foundation The Beat Pain Better study examines strategies to increase the reach of evidence-based interventions for persons with osteoarthritis (OA) in communities that ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5153859/

Feasibility and preliminary efficacy of a physical activity ... Physical activity (PA) reduces pain and improves functioning in people with knee osteoarthritis (OA), but few people with the condition meet recommended PA ...

6. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/10.1002/acr.20490

Evaluation of group and self‐directed formats of the Arthritis ... No adverse events were reported for either format. At 1 year, both formats showed modest improvement in ASE pain, but there were 5 outcomes ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10662528/

An observational pilot evaluation of the Walk with Ease ... Conclusions. Walk with Ease participation significantly increased self-reported physical activity but did not significantly improve physical ...

8. researchgate.net researchgate.net/publication/51115296_Evaluation_of_Group_and_Self-Directed_Formats_of_the_Arthritis_Foundation's_Walk_With_Ease_Program

Evaluation of Group and Self-Directed Formats of the ... No adverse events were reported for either format. At 1 year, both formats showed modest improvement in ASE pain, but there were 5 outcomes ...