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

346 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Text Messaging for osteoarthritis?

Research shows that using text messaging to provide information and support can improve physical health and reduce pain in people with osteoarthritis. Additionally, smartphone-based interventions, which include text messaging, have been found to help people with knee pain become more active and improve their mood. ^{1 2 3 4 5}

Is the Walk with Ease Program for Osteoarthritis safe for humans?

The Walk with Ease Program, designed for people with arthritis, has been evaluated in different formats and is generally considered safe for participants. Additionally, text messaging, which may be used in similar programs, has been shown to be a safe and effective tool for behavior change in disease management. ^{5 6 7 8 9}

How is the Walk with Ease Program using text messaging unique for treating osteoarthritis?

The Walk with Ease Program using text messaging is unique because it leverages digital communication to support and encourage patients with osteoarthritis to engage in regular exercise, which is a key component of managing the condition. Unlike traditional treatments that may rely on in-person visits, this approach provides ongoing motivation and guidance remotely, making it more accessible and convenient for patients. ^{4 10 11 12 13}

What is the purpose of this trial?

The Beat Pain Better study examines strategies to increase the reach of evidence-based interventions for persons with osteoarthritis (OA) in communities that experience disparities. The study is a hybrid type 3 effectiveness-imple-mentation trial using sequential, multiple assignment, ran¬domi¬zation to evaluate 1) two text mes¬saging strat¬egies to reach persons with OA and enroll them in physical activity counseling provided by physical therapists; and 2) two strat¬egies to engage enrolled persons in the Walk with Ease (WWE) intervention for sustained self-management.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

References

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

Automated Text-Messaging After Hip Arthroscopy: A Randomized-Controlled Trial of "Post-Op Buddy". [2022]

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

Perceptions about smartphone-based interventions to promote physical activity in inactive adults with knee pain - A qualitative study. [2023]

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

Can the provision of information to patients with osteoarthritis improve functional status? A randomized, controlled trial. [2022]

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

The effect of innovative smartphone application on adherence to a home-based exercise programs for female older adults with knee osteoarthritis in Saudi Arabia: a randomized controlled trial. [2022]

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

Osteoarthritis Index delivered by mobile phone (m-WOMAC) is valid, reliable, and responsive. [2022]

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

Effectiveness of an eHealth-delivered program to EMpower People with musculoskeletal pain in Rural Australia (EMPoweR): a randomised controlled trial. [2023]

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

Effect of a six-week walking program on work place activity limitations among adults with arthritis. [2022]

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

Text messaging as a tool for behavior change in disease prevention and management. [2022]

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

Evaluation of group and self-directed formats of the Arthritis Foundation's Walk With Ease Program. [2011]

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

Computer-based patient education for older persons with osteoarthritis. [2019]

11. United States 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. [2020]

12. England 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. [2022]

13. England 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. [2020]