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

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a program where health experts help patients with obesity and severe osteoarthritis manage their weight and improve their health while they wait for joint replacement surgery. The goal is to provide comprehensive support to improve their overall well-being during the waiting period.

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 the OA Optimization Program for Osteoarthritis safe for humans?

Pelvic floor muscle training (PFMT), which is part of the OA Optimization Program, is generally considered safe for humans and is commonly used to treat urinary incontinence and pelvic organ prolapse. ^{1 2 3 4 5}

How does the OA Optimization Program for Osteoarthritis treatment differ from other treatments?

The OA Optimization Program for Osteoarthritis is unique because it focuses on a comprehensive approach that includes patient education, supervised exercise, and self-management strategies, rather than relying solely on medication. This program is designed to help patients with mild to moderate osteoarthritis of the knee or hip improve their symptoms and quality of life through active participation and lifestyle changes. ^{6 7 8 9 10}

What data supports the effectiveness of the OA Optimization Program for Osteoarthritis treatment?

Research shows that pelvic floor muscle training (PFMT) is effective in improving urinary incontinence and pelvic organ prolapse, which suggests it could be beneficial for related conditions. This training involves exercises that strengthen the pelvic muscles, potentially improving quality of life for those with pelvic floor disorders. ^{1 3 11 12 13}

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

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]

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]

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]

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]

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 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]

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]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. [2018]

2. England 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. [2022]

3. Thailand pubmed.ncbi.nlm.nih.gov

Knowledge and acceptance of Thai women toward the pelvic floor muscle training. [2015]

4. United States 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. [2022]

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

Pelvic Floor Muscle Training: Underutilization in the USA. [2018]

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

Pelvic floor muscle training programme in pregnant Nepalese women-a feasibility study. [2021]

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

Self-management of incontinence using a free mobile app: factors associated with improvement. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Persuasive Technology in an mHealth App Designed for Pelvic Floor Muscle Training Among Women: Systematic Review. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The Active with OsteoArthritis (AktivA) Physiotherapy Implementation Model: A Patient Education, Supervised Exercise and Self-Management Program for Patients with Mild to Moderate Osteoarthritis of the Knee or Hip Joint. A National Register Study with a Two-Year Follow-Up. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The value of individual or collective group exercise programs for knee or hip osteoarthritis. Clinical practice recommendations. [2018]

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

Exercise, education, manual-therapy and taping compared to education for patellofemoral osteoarthritis: a blinded, randomised clinical trial. [2022]

12. 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]

13. England pubmed.ncbi.nlm.nih.gov

A 6-week hip muscle strengthening and lumbopelvic-hip core stabilization program to improve pain, function, and quality of life in persons with patellofemoral osteoarthritis: a feasibility pilot study. [2022]