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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Per-protocol adherence (feasibility)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Per-protocol adherence (feasibility)
时间窗: at interim (3 months)
per-protocol adherence to the intervention \>= 60%
Acceptability of Intervention Measure (AIM) score
时间窗: at interim (3 months) and study completion (10 months)
AIM scores compared between the intervention and control groups
Adverse events
时间窗: at interim (3 months)
rates of adverse events in the intervention and control arms
Study completion rates (feasibility)
时间窗: at study completion (10 months)
study completion rates \>= 80%
Qualitative data on participants perceptions of acceptability
时间窗: 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
次要结局
- physical function (6MWT distance)(change from baseline to interim (3 months) and study completion (10 months))
- physical function (chair stands)(change from baseline to interim (3 months) and study completion (10 months))
- muscle mass(change from baseline to interim (3 months) and study completion (10 months))