Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, The University of Melbourne, Melbourne, Australia.
Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia.
BMC Musculoskelet Disord. 2022 Jul 30;23(1):733. doi: 10.1186/s12891-022-05685-z.
Obesity is associated with knee osteoarthritis (OA). Weight loss, alongside exercise, is a recommended treatment for individuals with knee OA and overweight/obesity. However, many patients cannot access weight loss specialists such as dietitians. Innovative care models expanding roles of other clinicians may increase access to weight loss support for people with knee OA. Physiotherapists may be well placed to deliver such support. This two-group parallel, superiority randomized controlled trial aims to compare a physiotherapist-delivered diet and exercise program to an exercise program alone, over 6 months. The primary hypothesis is that the physiotherapist-delivered diet plus exercise program will lead to greater weight loss than the exercise program.
88 participants with painful knee OA and body mass index (BMI) > 27 kg/m will be recruited from the community. Following baseline assessment, participants will be randomised to either exercise alone or diet plus exercise groups. Participants in the exercise group will have 6 consultations (20-30 min) via videoconference with a physiotherapist over 6 months for a strengthening exercise program, physical activity plan and educational/exercise resources. Participants in the diet plus exercise group will have 6 consultations (50-75 min) via videoconference with a physiotherapist prescribing a ketogenic very low-calorie diet with meal replacements and educational resources to support weight loss and healthy eating, plus the intervention of the exercise only group. Outcomes are measured at baseline and 6 months. The primary outcome is percentage change in body weight measured by a blinded assessor. Secondary outcomes include self-reported knee pain, physical function, global change in knee problems, quality of life, physical activity levels, and internalised weight stigma, as well as BMI, waist circumference, waist-to-hip ratio, physical performance measures and quadriceps strength, measured by a blinded assessor. Additional measures include adherence, adverse events, fidelity and process measures.
This trial will determine whether a physiotherapist-delivered diet plus exercise program is more effective for weight loss than an exercise only program. Findings will inform the development and implementation of innovative health service models addressing weight management and exercise for patients with knee OA and overweight/obesity.
NIH US National Library of Medicine, Clinicaltrials.gov NCT04733053 (Feb 1 2021).
肥胖与膝骨关节炎（OA）有关。对于超重/肥胖的膝骨关节炎患者，减肥（联合运动）是一种推荐的治疗方法。然而，许多患者无法接触到营养师等减肥专家。扩展其他临床医生角色的创新护理模式可能会增加超重/肥胖的膝骨关节炎患者获得减肥支持的机会。物理治疗师可能更适合提供此类支持。本项两臂平行、优势随机对照试验旨在比较物理治疗师提供的饮食和运动方案与单纯运动方案在 6 个月中的效果。主要假设是，物理治疗师提供的饮食加运动方案将比运动方案导致更大的体重减轻。
将从社区招募 88 名患有疼痛性膝骨关节炎且 BMI＞27kg/m2的参与者。在基线评估后，参与者将被随机分配到仅运动组或饮食加运动组。运动组的参与者将通过视频会议与物理治疗师进行 6 次咨询（每次 20-30 分钟），以获得强化运动方案、体力活动计划和教育/运动资源。饮食加运动组的参与者将通过视频会议与物理治疗师进行 6 次咨询（每次 50-75 分钟），物理治疗师将开处酮基极低卡路里饮食，并使用代餐和教育资源来支持减肥和健康饮食，外加运动组的干预措施。结果在基线和 6 个月时进行测量。主要结局是由盲法评估者测量的体重百分比变化。次要结局包括自我报告的膝关节疼痛、身体功能、膝关节问题整体变化、生活质量、体力活动水平以及内化的体重耻辱感，以及由盲法评估者测量的 BMI、腰围、腰臀比、身体表现测量和股四头肌力量。其他测量包括依从性、不良事件、保真度和过程测量。
本试验将确定物理治疗师提供的饮食加运动方案与单纯运动方案相比，在减肥方面是否更有效。研究结果将为开发和实施创新的卫生服务模式提供信息，以解决超重/肥胖的膝骨关节炎患者的体重管理和运动问题。
美国国立卫生研究院美国国家医学图书馆，Clinicaltrials.gov NCT04733053（2021 年 2 月 1 日）。
