Clinical trial NCT05026385: The POMELO (Prevention Of MusclE Loss in Osteoarthritis) Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Obesity
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: The Arthritis Society, Canada
First posted: 2021-08-30
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Per-protocol adherence (feasibility)
timeFrame: at interim (3 months)
measure: Adverse events
timeFrame: at interim (3 months)
measure: Study completion rates (feasibility)
timeFrame: at study completion (10 months)
measure: Acceptability of Intervention Measure (AIM) score
timeFrame: at interim (3 months) and study completion (10 months)
measure: Qualitative data on participants perceptions of acceptability
timeFrame: at interim (3 months) and study completion (10 months)
Secondary outcomes:
measure: muscle mass
timeFrame: change from baseline to interim (3 months) and study completion (10 months)
measure: physical function (chair stands)
timeFrame: change from baseline to interim (3 months) and study completion (10 months)
measure: physical function (6MWT distance)
timeFrame: change from baseline to interim (3 months) and study completion (10 months)
Other outcomes:
measure: muscle quality
timeFrame: change from baseline to interim (3 months) and study completion (10 months)
measure: fat mass
timeFrame: change from baseline to interim (3 months) and study completion (10 months)
measure: patient-reported health-related quality of life
timeFrame: change from baseline to interim (3 months) and study completion (10 months)
measure: patient-reported arthritis-related pain and function
timeFrame: change from baseline to interim (3 months) and study completion (10 months)
measure: self-efficacy for managing chronic disease
timeFrame: change from baseline to interim (3 months) and study completion (10 months)
measure: lipid panel
timeFrame: change from baseline to interim (3 months) and study completion (10 months)
measure: c-reactive protein
timeFrame: change from baseline to interim (3 months) and study completion (10 months)
measure: insulin
timeFrame: change from baseline to interim (3 months) and study completion (10 months)
measure: albumin
timeFrame: change from baseline to interim (3 months) and study completion (10 months)
measure: liver enzymes
timeFrame: change from baseline to interim (3 months) and study completion (10 months)
measure: glucose
timeFrame: change from baseline to interim (3 months) and study completion (10 months)
measure: thyroid stimulating hormone
timeFrame: change from baseline to interim (3 months) and study completion (10 months)
measure: resting energy expenditure
timeFrame: change from baseline to interim (3 months) and study completion (10 months)
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Carla Prado, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Mary Forhan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Kristine Godziuk, PhD
role: PRINCIPAL_INVESTIGATOR
References: