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| Name | Class |
|---|---|
| The Arthritis Society, Canada | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Usual Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | Targeted nutrition advice, progressive resistance training exercise, and self-management support |
|
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| muscle quality | change in ultrasound-measured thigh muscle volume and echogenicity | change from baseline to interim (3 months) and study completion (10 months) |
| fat mass | change in fat mass assessed by DXA |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carla Prado, PhD | University of Alberta | Principal Investigator |
| Mary Forhan, PhD | University of Toronto | Principal Investigator |
| Kristine Godziuk, PhD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | T6G 2P5 | Canada |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| 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) |
| change from baseline to interim (3 months) and study completion (10 months) |
| patient-reported health-related quality of life | change in quality of life assessed by EQ-5D | change from baseline to interim (3 months) and study completion (10 months) |
| patient-reported arthritis-related pain and function | change in arthritis-related pain and function assessed by WOMAC | change from baseline to interim (3 months) and study completion (10 months) |
| self-efficacy for managing chronic disease | change in self-efficacy scores assessed by PROMIS | change from baseline to interim (3 months) and study completion (10 months) |
| lipid panel | change in blood assessed lipid panel (i.e. total cholesterol, LDL, HDL and triglycerides) | change from baseline to interim (3 months) and study completion (10 months) |
| c-reactive protein | change in blood assessed c-reactive protein | change from baseline to interim (3 months) and study completion (10 months) |
| insulin | change in blood assessed insulin | change from baseline to interim (3 months) and study completion (10 months) |
| albumin | change in blood assessed albumin | change from baseline to interim (3 months) and study completion (10 months) |
| liver enzymes | change in blood assessed liver enzymes (ALT and GGT) | change from baseline to interim (3 months) and study completion (10 months) |
| glucose | change in blood assessed glucose | change from baseline to interim (3 months) and study completion (10 months) |
| thyroid stimulating hormone | change in blood assessed thyroid stimulating hormone | change from baseline to interim (3 months) and study completion (10 months) |
| resting energy expenditure | change in resting energy expenditure using indirect calorimetry | change from baseline to interim (3 months) and study completion (10 months) |
| D012216 |
| Rheumatic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |