OA Optimization Program for Osteoarthritis

Overseen By Miriam Berchuk, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Calgary

Disqualifiers: Specialized diet, Pregnancy, Type 1 diabetes, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for individuals with osteoarthritis (OA) and obesity who are awaiting hip or knee replacement. It examines whether combining a weight management program with usual OA care can improve health while waiting for surgery. Participants will join either the Alberta Obesity Centre Program, which provides a team-based approach to weight management, or the Alberta Healthy Living Program for general chronic disease management. This trial suits those dealing with both osteoarthritis pain and obesity while awaiting joint replacement surgery. As a Phase 1 and Phase 2 trial, the research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.

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.

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

Research has shown that programs like the Alberta Obesity Centre Program help people manage their weight and health. These programs bring health experts together to support weight management and physical activity. Studies have found that staying active and managing weight are important for dealing with osteoarthritis (OA) and improving joint health.

Regarding safety, specific data on side effects from the Alberta Obesity Centre Program is not available. However, the program focuses on lifestyle changes like diet and exercise, which most people handle well, suggesting a low risk of harm. The trial is in its early stages, so it is still determining how well people tolerate the program.

For the Alberta Healthy Living Program, specific safety data is also unavailable. Like the obesity program, it uses a community-based approach to manage chronic diseases, focusing on lifestyle changes and education. These methods are usually safe for participants.

Overall, both programs emphasize safe methods like guidance on healthy living, without direct interventions that typically cause side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OA Optimization Program for Osteoarthritis because it brings together a range of strategies that address the condition from multiple angles. Unlike typical treatments that often focus solely on pain relief or joint function, this program includes the Alberta Obesity Centre Program, which uses a multidisciplinary approach to manage obesity—a key risk factor for osteoarthritis. Additionally, the Alberta Healthy Living Program offers a community-based chronic disease management framework, promoting sustainable lifestyle changes that could enhance overall health and potentially improve osteoarthritis outcomes. Together, these components aim to provide a more comprehensive and personalized management plan for osteoarthritis, potentially leading to better long-term results.

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

Research has shown that a team-based approach to managing obesity can help individuals with osteoarthritis (OA) improve their health. Participants in this trial may experience this method through the Alberta Obesity Centre Program, which includes medical care and lifestyle changes. Although it might not result in significant weight loss, it can enhance muscle function and may benefit those with early knee OA. The program aims to keep patients engaged in managing their weight and exercising to improve their health. Early indications suggest it could reduce the impact of OA while patients await surgery. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with a body mass index (BMI) over 30 and symptomatic osteoarthritis, who are awaiting joint replacement surgery. It's not suitable for those who can't read or speak English, use email or virtual platforms like Zoom, are pregnant or breastfeeding, have type 1 diabetes, or follow specialized diets.

Inclusion Criteria

Body mass index (BMI) greater than 30

I have painful joint arthritis and am being evaluated for joint replacement surgery.

Exclusion Criteria

Unable to use email

I have been diagnosed with type 1 diabetes.

Unable to use virtual platforms such as Zoom

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multidisciplinary obesity management program while awaiting surgical evaluation

12 months

Monthly virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

1 visit (in-person) at 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Alberta Healthy Living Program
• Alberta Obesity Centre Program
• Osteoarthritis advice
• Physiotherapy

Trial Overview The trial tests if adding the Alberta Obesity Centre program to usual care helps people with obesity and osteoarthritis improve their health while waiting for surgery. Participants will receive either standard advice on weight management and activity or be part of an intensive multidisciplinary treatment program.

How Is the Trial Designed?

Group I: Alberta Obesity Centre Program Experimental Treatment 3 Interventions

Evidence-based medical management of obesity using a multidisciplinary approach.

Group II: Alberta Healthy Living Program Active Control 3 Interventions

An integrated community-based chronic disease management program available to residents of Alberta.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

A survey of 415 Thai women revealed that many were unaware of the benefits of pelvic floor muscle training (PFMT) for managing conditions like urinary incontinence and pelvic organ prolapse, with 50% lacking knowledge about its efficacy.

Despite the limited understanding, a significant majority (84.6%) of women expressed willingness to practice PFMT if informed about its benefits, indicating a potential for increased acceptance and utilization of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge and acceptance of Thai women toward the pelvic floor muscle training. Tantisiriwat, N., Manchana, T.[2015]

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]

In a study of 2,153 women using the Tät® app for pelvic floor muscle training (PFMT), 65.6% reported improvement in urinary incontinence symptoms after 3 months, indicating the app's effectiveness as a self-management tool.

Regular use of the app and frequency of PFMT were key factors predicting both any improvement and significant improvement in symptoms, suggesting that consistent engagement with the app enhances treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management of incontinence using a free mobile app: factors associated with improvement. Nyström, E., Söderström, L., Samuelsson, E.[2022]

Pelvic floor muscle training (PFMT) is highly effective for women with stress urinary incontinence (UI), showing a significant cure rate with a relative risk (RR) of 8.38 based on high-quality evidence from 21 trials involving 1281 women.

For women with any type of urinary incontinence, PFMT also demonstrates moderate quality evidence of being associated with a cure (RR 5.5) or improvement, reinforcing its efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: a short version Cochrane systematic review with meta-analysis. Dumoulin, C., Hay-Smith, J., Habée-Séguin, GM., et al.[2022]

A pelvic floor muscle training (PFMT) program was developed and found to be acceptable among pregnant women in Nepal, with 57% attending the recommended four or more supervised visits.

The program showed promise in motivating women to perform daily PFMT at home, although no significant differences in urinary incontinence or pelvic organ prolapse symptoms were observed between those who attended the visits and those who did not.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training programme in pregnant Nepalese women-a feasibility study. Shijagurumayum Acharya, R., Tveter, AT., Grotle, M., et al.[2021]

In a randomized controlled trial involving 159 women with severe pelvic organ prolapse (POP), preoperative pelvic floor muscle training (PFMT) did not show any additional benefits in reducing urinary and colorectal-anal distress or improving quality of life compared to a control group.

Despite the lack of added benefit from PFMT, all participants experienced significant improvements in their symptoms and quality of life after surgery, indicating that surgery alone is effective for managing these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of preoperative pelvic floor muscle training on urinary and colorectal-anal distress in women undergoing pelvic organ prolapse surgery-a randomized controlled trial. Mathew, S., Nyhus, MØ., Salvesen, Ø., et al.[2022]

Pelvic floor muscle training (PFMT) is an effective and comprehensive treatment for pelvic floor disorders like urinary incontinence and pelvic organ prolapse, involving exercises tailored by trained clinicians.

Despite its proven efficacy and cost-effectiveness, PFMT is not widely adopted as a first-line treatment in the USA, highlighting a gap in clinical practice that could improve women's health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic Floor Muscle Training: Underutilization in the USA. Lamin, E., Parrillo, LM., Newman, DK., et al.[2018]

Citations

1. albertahealthservices.ca albertahealthservices.ca/assets/about/scn/ahs-scn-bjh-osteoarthritis-and-obesity-white-paper-final.pdf

Obesity: Implications for Patients with Osteoarthritis Although this combined intervention may not result in significant weight loss (defined as equal to or greater than 5% of body weight), the results are ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12314308/

Improving Muscle Function Through a Multimodal Behavioural ... The potential benefits of weight loss may be primarily in early knee OA [4], with limited effectiveness data and uncertainties of benefit in advanced OA [5].

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11909753/

Optimizing osteoarthritis care through clinical and community ... Feasibility metrics included engagement with the weight loss program and exercise resources. Outcomes were assessed at baseline, 6-months and 12 ...

4. withpower.com withpower.com/trial/phase-2-osteoarthritis-of-the-knee-4-2022-88913

OA Optimization Program for Osteoarthritis Trial Overview The trial tests if adding the Alberta Obesity Centre program to usual care helps people with obesity and osteoarthritis improve their health ...

5. oarsiopenjournal.com oarsiopenjournal.com/article/S2665-9131(23)00065-1/fulltext

The effect of geographic location and payor type on provincial ... Our study aims to assess whether there are differences in the effectiveness of the GLA:D™ program for hip and knee OA across program location (i.e., rural, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10922233/

The critical role of physical activity and weight ... Physical activity and weight management are critical components of an effective knee and hip osteoarthritis (OA) management plan.

7. clinicaltrial.be clinicaltrial.be/en/details/27620?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_eligible=0&only_active=0

OA Optimization Program Pilot Trial Our aim is to conduct a pilot randomized controlled trial (RCT) to evaluate the feasibility of incorporating the multidisciplinary Alberta ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1063458424000426

Review Obesity and body mass index: Past and future ... Obesity has clear relevance in osteoarthritis (OA), with strong evidence linking obesity to OA development and progression through increased mechanical joint ...