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

79 Participants Needed

Trial Summary

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 data supports the idea that Moving Well for Osteoarthritis is an effective treatment?

The available research shows that lifestyle behavioral changes, like those in the Moving Well program, can improve physical function, reduce pain, and decrease disability in people with osteoarthritis. For example, the Arthritis, Diet, and Activity Promotion Trial (ADAPT) found that combining exercise and dietary weight loss led to better physical function and less knee pain in older adults with knee osteoarthritis. This suggests that Moving Well, which focuses on similar lifestyle changes, can be an effective treatment for osteoarthritis. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Moving Well for osteoarthritis?

Research shows that lifestyle changes, including exercise and weight loss, can improve physical function and reduce pain in people with knee osteoarthritis. Group-based programs, like chair yoga, help maintain adherence to movement activities, which is crucial for managing osteoarthritis symptoms. ^{1 2 3 4 5}

What safety data exists for the Moving Well treatment for osteoarthritis?

The research indicates that in physical activity interventions, including those for osteoarthritis, no serious study-related adverse events were reported. Minor adverse events, primarily musculoskeletal injuries, were noted, emphasizing the need for caution regarding potential musculoskeletal issues during exercise interventions. The 'start low and go slow' strategy with moderate intensity physical activity is recommended to enhance safety. This suggests that the Moving Well treatment, which involves physical activity, is generally safe with proper precautions. ^{1 5 6 7 8}

Is the Moving Well intervention safe for humans?

Research on physical activity interventions, like Moving Well, shows that while minor injuries can occur, no serious adverse events have been reported. These studies emphasize starting slowly and gradually increasing activity to ensure safety. ^{1 5 6 7 8}

Is the treatment in the trial 'Moving Well for Osteoarthritis' a promising treatment?

Yes, the treatment in the 'Moving Well for Osteoarthritis' trial is promising. It focuses on exercise and lifestyle changes, which have been shown to improve physical function, reduce pain, and enhance quality of life for people with osteoarthritis. Programs like the YMCA Move for Health have demonstrated significant benefits, making this approach a valuable option for managing osteoarthritis. ^{1 6 9 10 11}

How does the 'Moving Well for Osteoarthritis' treatment differ from other treatments for osteoarthritis?

The 'Moving Well for Osteoarthritis' treatment is unique because it focuses on lifestyle behavioral changes, combining exercise and dietary weight loss to improve physical function and reduce pain in people with knee osteoarthritis. Unlike standard treatments that may focus solely on medication or surgery, this approach emphasizes sustainable lifestyle changes to manage symptoms and improve quality of life. ^{1 6 9 10 11}

What is the purpose of this trial?

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 undergoing total knee arthroplasty (TKA).

Research Team

Iris Y Navarro Millan, MD, MSPH

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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

Treatment Details

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.'

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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 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]

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]

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]

References

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

The Arthritis, Diet and Activity Promotion Trial (ADAPT): design, rationale, and baseline results. [2019]

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

Chair Yoga: Feasibility and Sustainability Study With Older Community-Dwelling Adults With Osteoarthritis. [2018]

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

Long-term impact of Fit and Strong! on older adults with osteoarthritis. [2022]

4. England 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. [2022]

5. United States 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. [2023]

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

A lifespan approach to osteoarthritis prevention. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of lifestyle diet and exercise interventions for osteoarthritis. [2022]

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

Evaluating the YMCA Move for Health Program in Individuals With Osteoarthritis and Assessing Maintenance During the COVID-19 Pandemic. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Exercise adherence Mobile app for Knee Osteoarthritis: protocol for the MappKO randomised controlled trial. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Physical activity, sedentary behaviour and well-being: experiences of people with knee and hip osteoarthritis. [2022]