Obesity, Osteoarthritis, Knee
Conditions
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.
Interventions
BEHAVIORALIntervention
Targeted nutrition advice, progressive resistance training exercise, and self-management support
Sponsors
The Arthritis Society, Canada
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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% |
| Acceptability of Intervention Measure (AIM) score | at interim (3 months) and study completion (10 months) | AIM scores compared between the intervention and control groups |
| Per-protocol adherence (feasibility) | at interim (3 months) | per-protocol adherence to the intervention \>= 60% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| physical function (chair stands) | change from baseline to interim (3 months) and study completion (10 months) | number of chair stands in 30 seconds |
| physical function (6MWT distance) | change from baseline to interim (3 months) and study completion (10 months) | 6MWT distance |
| muscle mass | change from baseline to interim (3 months) and study completion (10 months) | appendicular lean mass assessed by DXA |
Other
| Measure | Time frame | Description |
|---|---|---|
| albumin | change from baseline to interim (3 months) and study completion (10 months) | change in blood assessed albumin |
| liver enzymes | change from baseline to interim (3 months) and study completion (10 months) | change in blood assessed liver enzymes (ALT and GGT) |
| muscle quality | change from baseline to interim (3 months) and study completion (10 months) | change in ultrasound-measured thigh muscle volume and echogenicity |
| thyroid stimulating hormone | change from baseline to interim (3 months) and study completion (10 months) | change in blood assessed thyroid stimulating hormone |
| resting energy expenditure | change from baseline to interim (3 months) and study completion (10 months) | change in resting energy expenditure using indirect calorimetry |
| glucose | change from baseline to interim (3 months) and study completion (10 months) | change in blood assessed glucose |
| fat mass | change from baseline to interim (3 months) and study completion (10 months) | change in fat mass assessed by DXA |
| patient-reported health-related quality of life | change from baseline to interim (3 months) and study completion (10 months) | change in quality of life assessed by EQ-5D |
| patient-reported arthritis-related pain and function | change from baseline to interim (3 months) and study completion (10 months) | change in arthritis-related pain and function assessed by WOMAC |
| self-efficacy for managing chronic disease | change from baseline to interim (3 months) and study completion (10 months) | change in self-efficacy scores assessed by PROMIS |
| lipid panel | change from baseline to interim (3 months) and study completion (10 months) | change in blood assessed lipid panel (i.e. total cholesterol, LDL, HDL and triglycerides) |
| c-reactive protein | change from baseline to interim (3 months) and study completion (10 months) | change in blood assessed c-reactive protein |
| insulin | change from baseline to interim (3 months) and study completion (10 months) | change in blood assessed insulin |
Countries
Canada
Outcome results
None listed