Neuroscience Center, Clinic for Spinal Cord Injuries, Rigshospitalet, Hornbæk, Denmark
Department 9701, The University Hospitals Centre for Health Research, UCSF Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
BMJ Open. 2019 Dec 31;9(12):e030310. doi: 10.1136/bmjopen-2019-030310.
Spinal cord injury (SCI) predisposes those who suffer from it to physical inactivity and weight gain; consequently, death due to cardiovascular diseases is more frequent among people with SCI than in the general population. The literature documents a consensus about an interdisciplinary multimodal approach for the prevention and treatment of cardiovascular risk factors including overweight and obesity in people with SCI, focusing on diet, physical activity (PA) and behavioural interventions. This study will investigate implementation of recommendations from a recent clinical practice guideline for identification and management of cardiometabolic risk after SCI through multimodal patient education in a subacute clinical setting.
All patients who are aged 18 years or older with an SCI within the previous 12 months and admitted to highly specialised rehabilitation are included, regardless of SCI aetiology or neurological level. A primary study designed as a controlled, pragmatic, preintervention- postintervention study with 6-month follow-up evaluates the effect of the clinical intervention; a prospective national cohort study on body mass index (BMI) serves as a historical control. The intervention consists of a standardised approach to patient education about cardiovascular risk factors, PA and a healthy diet that begins at the outset of primary SCI rehabilitation and is integrated into existing settings and workflows. Outcome measures are collected at admission, discharge and 6 months after discharge and include peak oxygen uptake (VO2peak) (primary outcome), BMI, body composition, metabolic profile, neurological status, level of functioning, depression, quality of life, objective PA (accelerometry), self-reported PA, self-assessed PA ability, shared decision making, and dietary habits. Test-retest reliability of four VO2peak test protocols are investigated, as is test-retest reliability of a multisensor accelerometer in a rehabilitation setting.
The project is approved by the Committees on Health Research Ethics in the Capital Region of Denmark on 10 July 2018 (Journal-nr.: H-18018325). The principal investigator obtains informed consent from all participants. The interventions in the project are closely related to existing rehabilitation care, and the risk of pain and discomfort is considered modest. Any unintended events related to the elements of the intervention are reported, according to existing regional procedures. Data are stored in a secure web-based database (Redcap). The primary study and prospective cohort study are registered at Clinicaltrials.gov. Positive and negative results will be submitted to relevant scientific journals related to SCI for publication. Important protocol modifications are reported to the Committees on Health Research Ethics in the Capital Region of Denmark.
NCT03689023 and NCT03369080.
脊髓损伤（SCI）使患者容易出现身体活动减少和体重增加；因此，SCI 患者死于心血管疾病的风险高于普通人群。文献记录了一项共识，即对于 SCI 患者，应采用包括超重和肥胖在内的心血管危险因素的多学科综合治疗方法，重点是饮食、身体活动（PA）和行为干预。本研究将在亚急性临床环境中通过多模式患者教育，调查最近的临床实践指南中有关识别和管理 SCI 后心血管代谢风险的建议的实施情况。
所有年龄在 18 岁或以上，在过去 12 个月内患有 SCI 并接受高度专业康复治疗的患者，无论 SCI 的病因或神经水平如何，均纳入本研究。一项主要研究设计为具有 6 个月随访的对照、实用、干预前-干预后研究，评估临床干预的效果；一项关于体重指数（BMI）的前瞻性全国队列研究作为历史对照。干预措施包括对心血管危险因素、PA 和健康饮食进行标准化的患者教育，从原发性 SCI 康复开始，并整合到现有环境和工作流程中。入院时、出院时和出院后 6 个月收集结局测量值，包括峰值摄氧量（VO2peak）（主要结局）、BMI、身体成分、代谢谱、神经状态、功能水平、抑郁、生活质量、客观 PA（加速度计）、自我报告的 PA、自我评估的 PA 能力、共同决策和饮食习惯。研究还将调查四种 VO2peak 测试方案的测试-再测试可靠性，以及在康复环境中使用多传感器加速度计的测试-再测试可靠性。
该项目于 2018 年 7 月 10 日获得丹麦首都地区健康研究伦理委员会的批准（期刊编号：H-18018325）。主要研究者获得了所有参与者的知情同意。项目中的干预措施与现有康复护理密切相关，且疼痛和不适的风险被认为是适度的。任何与干预元素相关的意外事件均按照现有区域程序报告。数据存储在一个安全的基于网络的数据库（Redcap）中。主要研究和前瞻性队列研究在 Clinicaltrials.gov 上注册。阳性和阴性结果将提交给与 SCI 相关的相关科学期刊发表。向丹麦首都地区健康研究伦理委员会报告了重要的方案修改。
NCT03689023 和 NCT03369080。
