Skou Søren T, Nyberg Mette, Dideriksen Mette, Overgaard Jan A, Bodilsen Christine, Soja Anne Mb, Attarzadeh Amir P, Bieder Manuel J, Dridi Nadia P, Heltberg Andreas, Gæde Peter H, Reventlow Johan L, Arnfred Sidse, Bodtger Uffe, Thygesen Lau C, Jäger Madalina, Bricca Alessio
The Research Unit PROgrez, Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Region Zealand, Denmark.
Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense M, Denmark.
J Multimorb Comorb. 2023 Feb 1;13:26335565231154447. doi: 10.1177/26335565231154447. eCollection 2023 Jan-Dec.
Despite the great individual and societal burden associated with multimorbidity, little is known about how to effectively manage it.
The aim of this multicenter randomized controlled trial (RCT) is to investigate the 12-month effects of a personalized exercise therapy and self-management support program in addition to usual care in people with multimorbidity.
This is a protocol for a pragmatic, parallel-group (1:1 ratio), superiority RCT conducted at five intervention sites (two hospitals, a private practice physiotherapy clinic and two municipal rehabilitation centers) in Region Zealand, Denmark. A total of 228 persons with multimorbidity aged 18 years or older, will be randomly allocated to one of two groups. Both groups will receive usual care, defined as routine care for multimorbidity at the discretion of the treating doctor, while the intervention group will also participate in a 12-week exercise therapy and self-management support program tailored to people with multimorbidity at one of the intervention sites. The primary outcome will be the between-group difference in change in EQ-5D-5L from baseline to the follow-up at 12 months. Secondary outcomes include objectively-measured physical function and physical activity, inflammatory markers, disease and treatment burden, anxiety, depression, stress, sleep, pain and other self-reported parameters. In parallel with the RCT, an observational cohort will follow persons aged ≥18 years with multimorbidity not adhering to all eligibility criteria, as well as people fulfilling all eligibility criteria, but unwilling to participate in the RCT. This study was approved by the Regional Committee on Health Research Ethics for Region Zealand (SJ-857) and results will be communicated in scientific papers, at relevant conferences and to a broader audience.
Exercise therapy and self-management support is safe and effective in people with single conditions. However, it is still unclear whether this holds true for individuals with multimorbidity. This pragmatic, multicenter RCT will provide high-quality evidence on the benefits and harms of exercise therapy and self-management support and, if the results support it, lead to the development of a plan for implementation in clinical practice.
尽管多重疾病负担给个人和社会带来了巨大影响，但对于如何有效管理多重疾病却知之甚少。
这项多中心随机对照试验（RCT）的目的是，研究在多重疾病患者中，除常规治疗外，个性化运动疗法和自我管理支持项目的12个月效果。
这是一项实用的平行组（1:1比例）优效性RCT方案，在丹麦西兰岛地区的五个干预地点（两家医院、一家私人理疗诊所和两家市政康复中心）开展。总共228名18岁及以上的多重疾病患者将被随机分配到两组中的一组。两组都将接受常规治疗，即由主治医生酌情提供的多重疾病常规护理，而干预组还将在其中一个干预地点参加一项为期12周、针对多重疾病患者量身定制的运动疗法和自我管理支持项目。主要结局将是12个月随访时，两组在EQ-5D-5L从基线到随访的变化上的组间差异。次要结局包括客观测量的身体功能和身体活动、炎症标志物、疾病和治疗负担、焦虑、抑郁、压力、睡眠、疼痛以及其他自我报告的参数。与RCT并行，一个观察性队列将跟踪不符合所有纳入标准的18岁及以上多重疾病患者，以及符合所有纳入标准但不愿参加RCT的患者。本研究已获得西兰岛地区卫生研究伦理委员会（SJ-857）批准，研究结果将在科学论文、相关会议上公布，并面向更广泛的受众。
运动疗法和自我管理支持对单一疾病患者是安全有效的。然而，对于多重疾病患者是否同样如此仍不清楚。这项实用的多中心RCT将为运动疗法和自我管理支持的益处和危害提供高质量证据，如果结果支持，将促成在临床实践中实施的计划的制定。
