The POMELO (Prevention Of MusclE Loss in Osteoarthritis) Trial

Study Overview
=================
Brief 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.

Detailed Description
-----------------
The primary objectives of the POMELO study are to determine if a multicomponent behavioural intervention that includes personalized nutrition recommendations, progressive resistance training exercise, and chronic disease self-management support is feasible and acceptable for individuals living with advanced knee OA and a BMI ≥35 kg/m2. The secondary objectives are to assess potential effects of the intervention on muscle mass and physical function compared to usual care. The intervention is delivered over three months, followed by six months of ongoing maintenance support. Assessments are completed at baseline, interim (after the 3 month intervention phase), and at study end (after the 6 month maintenance phase) [for a total study period of 10 months]. This project will inform and influence the future development and implementation of more personalized knee OA treatment approaches for adults with a BMI ≥35 kg/m2 and reduce health disparities in access to effective care. Findings will also contribute to improved health outcomes for this vulnerable patient population, and enhanced delivery of health services by offering an alternative treatment pathway targeted to patient needs.

Official Title
-----------------
Targeted Knee Osteoarthritis Care for Adults With a BMI ≥35 kg/m2: the Prevention Of MusclE Loss in Osteoarthritis (P.O.M.E.L.O.) Feasibility and Pilot Randomized Trial

Conditions
-----------------
Osteoarthritis, Knee, Obesity

Intervention / Treatment
-----------------
* Behavioral: Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention group will receive initial nutrition and exercise consultations with a Registered Dietitian (RD) and Clinical Exercise Physiologist (CEP) to personalize the study protocol and recommendations to their needs. The intervention period (3 months) includes: a) whole-body resistance training exercise sessions completed three-times per week (at-home with loaned equipment and/or in-person at the research gym); b) biweekly nutrition education provided through video conferencing; and c) biweekly OA self-management support provided through video conferencing. After the 3 month intervention, participants will receive bimonthly phone calls from a study staff member to encourage continued behavior changes during the 6 month maintenance phase. | Behavioral: Intervention<br>* Targeted nutrition advice, progressive resistance training exercise, and self-management support<br>|
| No Intervention: Usual Care<br>The control group will follow standard care procedures, which includes their usual activities. The control group will receive bimonthly contact during the study period through phone calls with a study staff member to encourage retention. However no recommendations or advice on nutrition, exercise or self-management will be provided. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Per-protocol adherence (feasibility) | per-protocol adherence to the intervention >= 60% | at interim (3 months) | 
| Adverse events | rates of adverse events in the intervention and control arms | at interim (3 months) | 
| Study completion rates (feasibility) | study completion rates >= 80% | at study completion (10 months) | 
| Acceptability of Intervention Measure (AIM) score | AIM scores compared between the intervention and control groups | at interim (3 months) and study completion (10 months) | 
| Qualitative data on participants perceptions of acceptability | qualitative data from open-ended survey and interview questions under each domain of the Theoretical Framework of Acceptability | at interim (3 months) and study completion (10 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle mass | appendicular lean mass assessed by DXA | change from baseline to interim (3 months) and study completion (10 months) | 
| physical function (chair stands) | number of chair stands in 30 seconds | change from baseline to interim (3 months) and study completion (10 months) | 
| physical function (6MWT distance) | 6MWT distance | change from baseline to interim (3 months) and study completion (10 months) |