The POMELO (Prevention Of MusclE Loss in Osteoarthritis) Trial

Not Applicable

Completed

• Conditions: Obesity; Osteoarthritis, Knee

• Registration Number: NCT05026385
• Lead Sponsor: University of Alberta

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.

Study Timeline

• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-30
• Study Start: 2021-09-20
• Primary Completion: 2023-07-21
• Study Completion: 2023-07-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada