Moving Well for Osteoarthritis

Overseen By Vanessa Madrigal, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Non-English speakers, Unable to exercise, RA, others

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

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a program called Moving Well can reduce anxiety and depression in individuals preparing for knee replacement surgery. Participants in the Moving Well group will receive weekly calls from a peer coach, an exercise plan, and mental preparation tips. In contrast, the Staying Well group will receive calls about general health topics. This study targets individuals with knee surgery scheduled in at least eight weeks, who are willing to work with a coach, and have internet access. The trial aims to determine if these support methods can improve mental health around the time of surgery. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance mental health support for future patients undergoing knee surgery.

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

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Moving Well behavioral intervention is safe for patients undergoing total knee arthroplasty?

Research has shown that in studies focused on physical activity, including those for osteoarthritis, participants reported no serious side effects related to the study. This is encouraging for those considering joining the Moving Well study. So far, the combination of peer coaching, mental preparation, and exercise appears well-received. Participants in similar programs have not experienced harmful effects directly linked to the treatment. This suggests that Moving Well is likely safe for people considering this clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Moving Well for Osteoarthritis" protocol because it combines peer coaching, exercise, and mental preparation to support patients before and after knee surgery. Unlike standard care, which typically focuses on medication and physical therapy alone, this approach emphasizes mental readiness through positive thinking and personalized guidance from someone who has been through the experience. The inclusion of peer support and tailored mental strategies could enhance recovery and improve patient outcomes, offering a more holistic approach to managing osteoarthritis.

What evidence suggests that this trial's treatments could be effective for anxiety and depression in patients undergoing total knee arthroplasty?

Research shows that the Moving Well program, one of the treatment arms in this trial, is based on a successful plan called Living Healthy, which used exercise to reduce joint pain. Past studies have shown that exercise and mental preparation help lower anxiety and depression. Participants in the Moving Well arm will receive weekly calls, an exercise routine, and positive thinking to prepare for surgery. These components aim to improve mental health and reduce the stress of knee surgery. Although complete data on how Moving Well affects anxiety and depression after surgery is not yet available, the program builds on proven methods of physical and mental preparation. ^{1 2 3 6 7}

Who Is on the Research Team?

Iris Y Navarro Millan, MD, MSPH

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals aged 50 or older with high anxiety or depression, who have internet access and can travel to NYC. They must be scheduled for their first knee replacement in at least 8 weeks and willing to work with a coach. Priority goes to those with low socioeconomic status or from underrepresented racial groups.

Inclusion Criteria

Have access to the internet and a computer

You are able to travel to New York City (Upper East Side) for in-person data collection visits.

≥60 years of age

Exclusion Criteria

Non-English speakers

The intervention will first be delivered in English to ensure feasibility with the content before adapting the material for patients who speak other languages.

Unable to exercise (e.g., bed bound or wheelchair bound)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Intervention

Participants receive weekly calls from a peer coach or research assistant, an exercise program, and mental preparation for surgery

7 weeks

7 weekly calls

Post-surgery Intervention

Participants continue to receive weekly calls for support and monitoring after surgery

5 weeks

5 weekly calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Moving Well
• Staying Well

Trial Overview The study tests 'Moving Well,' a behavioral intervention aimed at reducing anxiety and depression in patients awaiting knee replacement surgery. Participants will either receive this intervention or join the control group, which involves an alternative program called 'Staying Well.'

How Is the Trial Designed?

Group I: Moving Well Experimental Treatment 1 Intervention

Participants will receive weekly calls for 12 weeks (7 weeks before total knee arthroplasty surgery and 5 weeks after surgery) from a peer coach, an exercise program, and mental preparation (through positive thinking) for surgery. Participants will also receive the standard of care for patients undergoing total knee arthroplasty.

Group II: Staying Well Active Control 1 Intervention

Participants will receive weekly calls for 12 weeks (7 weeks before total knee arthroplasty surgery and 5 weeks after surgery) from a research assistant. The calls will be similar in length to those in the experimental arm and will cover various health topics not related to total knee arthroplasty. Participants will also receive the standard of care for patients undergoing total knee arthroplasty.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Rheumatology Research Foundation

Collaborator

Trials

14

Recruited

8,200+

Hospital for Special Surgery, New York

Collaborator

Trials

257

Recruited

61,800+

Published Research Related to This Trial

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]

The 12-week YMCA Move for Health exercise program significantly improved disability, pain, fatigue, and health-related quality of life in adults with osteoarthritis, with 66 participants showing measurable benefits post-program.

Despite challenges from the COVID-19 pandemic, participants maintained most of their improvements in symptoms and quality of life three months after completing the program, indicating its effectiveness and feasibility for managing osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the YMCA Move for Health Program in Individuals With Osteoarthritis and Assessing Maintenance During the COVID-19 Pandemic. Neudorf, B., Hughes, C., Ellis, C., et al.[2022]

The Arthritis, Diet, and Activity Promotion Trial (ADAPT) involved 316 sedentary, overweight, and obese older adults with knee osteoarthritis, testing the effects of lifestyle changes over 18 months on physical function and pain.

The study aims to identify effective behavioral therapies that can help reduce disability from knee OA, focusing on interventions like dietary weight loss and structured exercise, which are based on established psychological principles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Arthritis, Diet and Activity Promotion Trial (ADAPT): design, rationale, and baseline results. Miller, GD., Rejeski, WJ., Williamson, JD., et al.[2019]

Osteoarthritis prevention is an underdeveloped field, with most existing knowledge focused on the disease's biology rather than on modifiable risk factors that contribute to its burden.

The review emphasizes the importance of addressing obesity and joint injury as key risk factors for osteoarthritis, suggesting that a lifespan approach to prevention could be more effective than solely targeting older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A lifespan approach to osteoarthritis prevention. Whittaker, JL., Runhaar, J., Bierma-Zeinstra, S., et al.[2022]

The paper outlines a set of best practices for conducting clinical trials focused on lifestyle diet and exercise interventions for osteoarthritis (OA), aimed at both newcomers and experienced researchers in the field.

These recommendations cover essential aspects of trial design, including participant recruitment, study methods, and assessment techniques, providing a comprehensive guide for effective research in OA interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of lifestyle diet and exercise interventions for osteoarthritis. Messier, SP., Callahan, LF., Golightly, YM., et al.[2022]

The Engage-PA intervention, a brief behavioral program for older adults with osteoarthritis, showed high feasibility and acceptability, with 100% participant accrual and 89% reporting it as helpful.

Participants in the Engage-PA group experienced significant improvements in arthritis pain severity and self-reported physical activity compared to those receiving standard treatment, despite challenges posed by the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linking physical activity to personal values: feasibility and acceptability randomized pilot of a behavioral intervention for older adults with osteoarthritis pain. Plumb Vilardaga, JC., Kelleher, SA., Diachina, A., et al.[2022]

The Fit and Strong! intervention, which combines exercise and behavior change strategies, significantly improved self-efficacy for exercise and increased weekly exercise minutes in older adults with lower extremity osteoarthritis, with benefits maintained for up to 12 months.

Participants in the treatment group also experienced reduced lower extremity stiffness and pain, with no adverse health effects reported, indicating that this low-cost program is both safe and effective for managing osteoarthritis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term impact of Fit and Strong! on older adults with osteoarthritis. Hughes, SL., Seymour, RB., Campbell, RT., et al.[2022]

A study involving 182 Australians with knee osteoarthritis is testing whether adding a mobile app to a prescribed exercise program can improve adherence to home-based strengthening exercises over 24 weeks.

The app is designed to track exercise completion and provide personalized support, aiming to enhance physical function and exercise adherence compared to traditional physiotherapy alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise adherence Mobile app for Knee Osteoarthritis: protocol for the MappKO randomised controlled trial. Hinman, RS., Nelligan, RK., Campbell, PK., et al.[2022]

An 8-week seated yoga program for older adults with osteoarthritis was found to be feasible, but participants struggled to continue practicing yoga at home without group support.

The study highlights the importance of group settings in promoting adherence to movement-based programs for older adults, suggesting that social interaction may be key to maintaining physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chair Yoga: Feasibility and Sustainability Study With Older Community-Dwelling Adults With Osteoarthritis. McCaffrey, R., Park, J., Newman, D.[2018]

Individuals with knee and hip osteoarthritis (OA) value mobility and actively negotiate their physical activity (PA) levels to maintain it, despite the challenges posed by their condition.

The study highlights the importance of linking physical activity recommendations to personal values and well-being, while also addressing safety concerns related to OA, to encourage a more active lifestyle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity, sedentary behaviour and well-being: experiences of people with knee and hip osteoarthritis. Kanavaki, AM., Rushton, A., Hale, E., et al.[2022]

A digital behavior change intervention (DBCI) was co-developed with input from patients with osteoarthritis (OA) to motivate them to increase physical activity, addressing the issue that nearly half of OA patients are inactive.

The intervention was designed using a theoretical framework and emphasized the importance of clear, enjoyable, and socially connected information, which could help users integrate the digital tools into their daily lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic co-development and testing of a digital behaviour change intervention for osteoarthritis and physical activity: Theoretical mapping and acceptability study. Berry, A., McCabe, CS., Muir, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10160708/

PMC The primary outcome is the difference in levels of anxiety and/or depression between participants in the Moving Well and Staying Well groups 6 months after TKR.

2. trials.arthritis.org trials.arthritis.org/trials/NCT05217420

Moving Well for Total Knee Arthroplasty (TKA) The purpose of this study is to assess the efficacy of a behavioral intervention, Moving Well, in improving levels of anxiety and depression for patients ...

3. clinicaltrial.be clinicaltrial.be/en/details/33554?per_page=100&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Moving Well for Total Knee Arthroplasty (TKA) Scores range from 0 to 52 with higher scores indicating a higher level of pain-related anxiety. 4. Change in level of knee pain and function ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11638140/

Training of Peer Coaches to Assist Individuals with Knee ... Moving Well was adapted from the Living Healthy intervention, an intervention that was effective in using exercise to reduce joint pain in Black women with ...

5. withpower.com withpower.com/trial/phase-osteoarthritis-knee-3-2022-7901c

Moving Well for Osteoarthritis · Info for Participants The purpose of this study is to assess the efficacy of a behavioral intervention, Moving Well, in improving levels of anxiety and depression for patients ...

6. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-023-06460-4

A single-center, open-label, randomized, parallel-group trial to ... This study will pilot test the feasibility and effectiveness of Moving Well, a peer coach intervention, alongside principles of CBT and home exercise.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1063458424013232

Osteoarthritis Year In Review 2024: Rehabilitation and ... An RCT in people with hand OA found that a home exercise program did not improve muscle strength, range of motion, pain, or function in 190 participants.