Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury

多模式干预改善脊髓损伤的功能和代谢

• 批准号: 10764596
• 负责人: SHALENDER BHASIN
• 金额: $ 44.64万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-21 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10764596
• 关键词: Administrative Supplement; Aerobic; Anxiety; Applications Grants; Area; Bone Density; COVID-19 pandemic; Caregiver Burden; Clinical Research; Enrollment; Ergometry; Exercise; FPS-FES Oncogene; Fatty acid glycerol esters; Funding; Grant; Health; Healthcare; Home; Hybrids; Impairment; Intervention; Investments; Life; Lipids; Medical center; Metabolic; Metabolism; Monitor; Moods; Musculoskeletal; Pain; Parents; Participant; Patient Self-Report; Personal Satisfaction; Persons; Pharmacologic Substance; Physical Performance; Physiological; Placebos; Ramp; Randomized; Recovery of Function; Request for Applications; Research; Research Activity; Resources; Spinal cord injury; Spinal cord injury patients; Suspensions; Testing; Testosterone; Training; Translating; United States National Institutes of Health; age stratification; arm; body system; bone; clinical practice; computerized; coronavirus disease; cost; design; efficacy evaluation; exercise training; functional improvement; improved; indexing; inflammatory marker; innovation; insulin sensitivity; laboratory experiment; motor function improvement; multi-component intervention; multimodality; muscle form; muscle strength; primary outcome; programs; randomized placebo controlled trial; randomized trial; rehabilitation research; satisfaction; secondary outcome; sex

Abstract This application for an administrative supplement requests approval for a one-year extension with partial funding to enable the completion of this ongoing randomized trial that is currently in its fifth year of funding. The funded trial aims to test the hypothesis that a multi-modality intervention that includes hybrid exercise plus testosterone and targets deficits in multiple physiologic organ systems will be more efficacious in improving musculoskeletal and metabolic health and wellbeing of people living with SCI than hybrid excise plus placebo. This hypothesis is being tested in a randomized trial in 88 persons with C7 to T12 SCI, AIS grade A, B or C, 6 months or later after SCI. Participants are being randomized to either the multi-modality intervention or hybrid exercise plus placebo for 16 weeks, stratified by age, sex, and AIS grade. After 2-weeks of training in the exercise laboratory, the intervention is conducted in the participant’s home, using video monitoring of the home exercise. Primary outcome is peak aerobic capacity. Secondary outcomes include self-reported function and mobility assessed using computerized adaptive test version of Spinal Cord Injury-Functional Index; muscle mass and strength; fat mass and fat distribution; insulin sensitivity; lipids; inflammatory markers; and wellbeing (mood, anxiety, pain, and life satisfaction). The aims or the design of the funded trial have not changed. Very shortly after the trial's initiation, the sudden onset of the COVID pandemic led to nationwide shutdown of most non-covid clinical research activities. Due to the complete shutdown of clinical research for several months in 2022 followed by slow ramp up of clinical research activities in 2020 and 2021 due to multitude of factors that are discussed in the application, the enrollment in the trial suffered. In spite of these COVID-related challenges, the enrollment in the trial during the past year has increased substantially and the current enrollment rate exceeds that projected in the original grant application. Therefore, the parent as well as the supplemental bone study are on target for completion in the coming year. An additional year of partial support of the project would enable completion and close-out of the trial, accomplishment of all the proposed aims of the project, and accrual of full returns on the NIH's generous investment in this important project of high priority to people living with a SCI. Spinal cord injury (SCI) is one of the most grievous conditions that greatly impairs a person's mobility, function, overall health, and wellbeing, and increases healthcare resource utilization and costs and caregiver burden. The National Center for Medical Rehabilitation research has designated “pharmaceutical, stimulation, and exercise…strategies to improve motor function and health of SCI patients” a priority area of research. Because all components of the multimodality intervention are commercially available, the findings of this innovative trial upon its completion could be expeditiously translated into clinical practice and improve the health and wellbeing of people with SCI.

抽象的 此申请申请行政补充请求批准为期一年的延期，部分 资金以实现当前正在进行的随机试验的完成。 该资助的试验旨在检验以下假设，即包括混合锻炼的多模式干预措施 睾丸激素和靶标在多个生理器官系统中定义将更有效地改善 与混合娱乐和安慰剂相比，肌肉骨骼和代谢健康以及SCI患者的福祉。 该假设正在在88名C7至T12 SCI，AIS A，B或C的随机试验中进行检验。6 科幻后几个月或更晚。参与者正在随机分配多模式干预或混合动力 运动加安慰剂16周，按年龄，性别和AIS等级进行分层。经过2周的培训 锻炼实验室，干预措施是在参与者的房屋中进行的，使用房屋的视频监控 锻炼。主要结果是峰值有氧能力。次要结果包括自我报告的功能和 使用计算机化自适应测试版本的脊髓损伤功能指数评估的移动性；肌肉 质量和力量；脂肪质量和脂肪分布；胰岛素敏感性；脂质；炎症标记；和幸福 （情绪，焦虑，痛苦和生活满意度）。资助试验的目的或设计没有改变。 在审判倡议之后不久，共同大流行的突然发作导致全国关闭 大多数非杂化临床研究活动。由于几个临床研究的完全关闭 2022年的月份，随后由于众多 应用程序中讨论的因素，试验的入学人数受到了影响。尽管有这些相关相关的 挑战，过去一年中试验的入学人数大大增加了 入学率超过了原始赠款申请中预计的。因此，父母以及 补充骨研究是在来年完成的目标。额外的部分支持一年 该项目的完成将使审判完成和结束，完成所有提议的目标 该项目，以及对NIH对这个高优先级重要项目的慷慨投资的全部回报 给有科幻的人。 脊髓损伤（SCI）是最严重的疾病之一，严重损害了一个人的活动性，功能， 总体健康，福祉，并增加医疗保健资源利用率和成本以及护理人员伯恩（Burnen）。 国家医学康复研究中心设计了“药物，刺激和 锻炼…改善SCI患者运动功能和健康状况的策略”是研究的优先领域。 多模式干预的所有组成部分都在市售，这是此创新试验的发现 完成后，可以迅速将其转化为临床实践，并改善健康状况 有科幻的人的健康。