The POMELO (Prevention Of MusclE Loss in Osteoarthritis) Trial (NCT05026385) | Clinical Trial Compass
CompletedNot Applicable
The POMELO (Prevention Of MusclE Loss in Osteoarthritis) Trial
Canada50 participantsStarted 2021-09-20
Plain-language summary
Treatment options for individuals who have advanced knee osteoarthritis (OA) and a body mass index (BMI) ≥35 kg/m2 are limited, and this patient population may be neglected in current clinical care pathways for OA management. These individuals are considered to be at high risk for complications with total knee arthroplasty (TKA), and as a result may not be eligible for this procedure unless they lose significant weight. However, there is limited evidence for endorsing weight loss as beneficial prior to TKA. Further, unsupervised weight loss could put patients at risk for muscle loss and development of sarcopenic obesity, a health condition that negatively impacts mobility and mortality. This suggests that weight loss might not be the primary treatment goal for this patient population. Integrated non-surgical treatment approaches are needed that can target the specific needs of this knee OA patient group. This study will examine the feasibility and acceptability of a personalized, multicomponent intervention, and its effects on body composition and physical function compared to usual care.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* body mass index (BMI) ≥35 kg/m2
* unilateral or bilateral knee osteoarthritis (KL grade ≥2 and clinical symptoms)
* able to provide written, informed consent in English
* able to attend assessment appointments in Edmonton, Alberta
* have reliable and unlimited access to internet and a laptop, computer or tablet at home for access to videoconferencing sessions
* have space at home to complete exercises with equipment provided, or able to attend in-person exercise sessions
Exclusion Criteria:
* any medical conditions where participation in resistance exercise or nutrition adjustments are contraindicated
* neurological disorders (i.e. multiple sclerosis)
* post-traumatic OA with a fracture that impacts joint (secondary to injury or accident)
* rheumatoid arthritis
* prior bariatric surgery
* prior knee or hip replacement surgery
* recently (within 3 months) taken anabolic steroids or other muscle building compounds
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Per-protocol adherence (feasibility)
Timeframe: at interim (3 months)
2
Adverse events
Timeframe: at interim (3 months)
3
Study completion rates (feasibility)
Timeframe: at study completion (10 months)
4
Acceptability of Intervention Measure (AIM) score
Timeframe: at interim (3 months) and study completion (10 months)
5
Qualitative data on participants perceptions of acceptability
Timeframe: at interim (3 months) and study completion (10 months)