70 Participants Needed

OA Optimization Program for Osteoarthritis

MB
Overseen ByMiriam Berchuk, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Calgary
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.13111213

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
See 2 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Alberta Obesity Centre ProgramExperimental Treatment3 Interventions
Evidence-based medical management of obesity using a multidisciplinary approach.
Group II: Alberta Healthy Living ProgramActive Control3 Interventions
An integrated community-based chronic disease management program available to residents of Alberta.

Find a Clinic Near You

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.
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.
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.
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]

Citations

A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. [2018]
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]
Knowledge and acceptance of Thai women toward the pelvic floor muscle training. [2015]
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]
Pelvic Floor Muscle Training: Underutilization in the USA. [2018]
Pelvic floor muscle training programme in pregnant Nepalese women-a feasibility study. [2021]
Self-management of incontinence using a free mobile app: factors associated with improvement. [2022]
Persuasive Technology in an mHealth App Designed for Pelvic Floor Muscle Training Among Women: Systematic Review. [2022]
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]
The value of individual or collective group exercise programs for knee or hip osteoarthritis. Clinical practice recommendations. [2018]
Exercise, education, manual-therapy and taping compared to education for patellofemoral osteoarthritis: a blinded, randomised clinical trial. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Evaluating the YMCA Move for Health Program in Individuals With Osteoarthritis and Assessing Maintenance During the COVID-19 Pandemic. [2022]
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]
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