Testosterone and long pulse width stimulation (TLPS) for denervated muscles after spinal cord injury: a study protocol of randomised clinical trial.
Testosterone and long pulse width stimulation (TLPS) for denervated muscles after spinal cord injury: a study protocol of randomised clinical trial.
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DOI：
10.1136/bmjopen-2022-064748
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发表时间：
2022-10-05
期刊：
影响因子：
2.9
通讯作者：
中科院分区：
文献类型：
--
作者：
长脉冲宽度刺激（LPWS; 120-150 ms）具有刺激失神经肌肉和恢复脊髓损伤（SCI）失神经患者肌肉大小的潜力。我们将确定睾酮治疗（TT）+LPWS是否会增加骨骼肌大小，腿部瘦体重并改善去神经SCI患者的整体代谢健康。我们假设1年TT+LPWS将上调蛋白质合成途径，下调蛋白质降解途径，并增加整体线粒体健康。24名膝伸肌去神经支配且耐受LPWS范式的男性受试者（年龄18-70岁，患有慢性SCI）将被随机分配至TT+神经肌肉电刺激（通过远程医疗）或TT+LPWS。培训课程每周两次，为期一年。将在培训前1周（基线;第0周）、培训后6个月（干预后1）和1年培训结束后1周（干预后2）进行测量。测量将包括身体成分评估，使用人体测量法，双X射线吸收测量法和MRI测量不同肌肉群的大小。代谢特征将包括测量基础代谢率，然后抽血测量类似于血红蛋白A1 c的空腹生物标志物、血脂、C反应蛋白、白细胞介素-6和游离脂肪酸，然后进行静脉葡萄糖耐量试验，以检测胰岛素敏感性和葡萄糖有效性。最后，将捕获肌肉活检以测量蛋白质表达和细胞内信号传导;以及线粒体电子传递链功能。参与者将填写3天的饮食记录，以每周监测他们的能量摄入量。该研究获得了McGuire Research Institute机构审查委员会的批准（ID # 02189）。传播计划将包括退伍军人健康管理局及其从业人员，国家SCI/D服务办公室，一般医疗保健社区和退伍军人群体，以及通过提交季度信函或同行评审文章的整个SCI社区。NCT 03345576。
Long pulse width stimulation (LPWS; 120–150 ms) has the potential to stimulate denervated muscles and to restore muscle size in denervated people with spinal cord injury (SCI). We will determine if testosterone treatment (TT)+LPWS would increase skeletal muscle size, leg lean mass and improve overall metabolic health in persons with SCI with denervation. We hypothesise that the 1-year TT+LPWS will upregulate protein synthesis pathways, downregulate protein degradation pathways and increase overall mitochondrial health. Twenty-four male participants (aged 18–70 years with chronic SCI) with denervation of both knee extensor muscles and tolerance to the LPWS paradigm will be randomised into either TT+neuromuscular electrical stimulation via telehealth or TT+LPWS. The training sessions will be twice weekly for 1 year. Measurements will be conducted 1 week prior training (baseline; week 0), 6 months following training (postintervention 1) and 1 week after the end of 1 year of training (postintervention 2). Measurements will include body composition assessment using anthropometry, dual X-ray absorptiometry and MRI to measure size of different muscle groups. Metabolic profile will include measuring of basal metabolic rate, followed by blood drawn to measure fasting biomarkers similar to hemoglobin A1c, lipid panels, C reactive protein, interleukin-6 and free fatty acids and then intravenous glucose tolerance test to test for insulin sensitivity and glucose effectiveness. Finally, muscle biopsy will be captured to measure protein expression and intracellular signalling; and mitochondrial electron transport chain function. The participants will fill out 3 days dietary record to monitor their energy intake on a weekly basis. The study was approved by Institutional Review Board of the McGuire Research Institute (ID # 02189). Dissemination plans will include the Veteran Health Administration and its practitioners, the national SCI/D services office, the general healthcare community and the veteran population, as well as the entire SCI community via submitting quarterly letters or peer-review articles. NCT03345576.
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