Department for Health, University of Bath, Bath, UK.
The Miami Project to Cure Paralysis, University of Miami, Miller School of Medicine, Miami, FL, USA.
Spinal Cord. 2021 Jan;59(1):44-54. doi: 10.1038/s41393-020-0486-7. Epub 2020 Jun 3.
Nonrandomized clinical trial (NCT02354625).
As a part of a Phase I clinical trial to assess the safety of autologous human Schwann cells (ahSC) in persons with chronic spinal cord injury (SCI), participants engaged in a multimodal conditioning program pre- and post-ahSC transplantation. The program included a home-based strength and endurance training program to prevent lack of fitness and posttransplantation detraining from confounding potential ahSC therapeutic effects. This paper describes development, deployment, outcomes, and challenges of the home-based training program.
University-based laboratory.
Development phase: two men with paraplegia completed an 8-week laboratory-based 'test' of the home-based program. Deployment phase: the first four (two males, two females) participant cohort of the ahSC trial completed the program at home for 12 weeks pre and 20 weeks post ahSC transplant.
Development phase: both participants improved their peak aerobic capacity (VO) (≥17%), peak power output (PO) (≥8%), and time to exhaustion (TTE) (≥7%). Deployment phase: pretransplant training minimally increased fitness in the two male participants (≥6% PO and ≥9% TTE). The two women had no PO changes and slight TTE changes (+2.6 and -1.2%, respectively.) All four participants detrained during the posttransplant recovery period. After posttransplant retraining, all four participants increased TTE (4-24%), three increased VO (≥11%), and two increased PO (≥7%) CONCLUSIONS: Home-based strength and condition programs can be effective and successfully included in therapeutic SCI trials. However, development of these programs requires substantial content knowledge and experience.
非随机临床试验（NCT02354625）。
作为评估自体人雪旺细胞（ahSC）在慢性脊髓损伤（SCI）患者安全性的 I 期临床试验的一部分，参与者在 ahSC 移植前后进行了多模式调理方案。该方案包括基于家庭的力量和耐力训练计划，以防止缺乏健身和移植后训练对潜在 ahSC 治疗效果的混淆。本文描述了基于家庭的训练计划的开发、部署、结果和挑战。
大学实验室。
开发阶段：两名截瘫患者完成了基于实验室的家庭训练计划“测试”。部署阶段：ahSC 试验的前四个（两男两女）参与者队列在家中完成了 12 周的预移植和 20 周的 postahSC 移植训练。
开发阶段：两名参与者的峰值有氧运动能力（VO）（≥17%）、峰值功率输出（PO）（≥8%）和疲劳时间（TTE）（≥7%）均有所提高。部署阶段：移植前训练使两名男性参与者的体能略有增加（≥6%的 PO 和≥9%的 TTE）。两名女性的 PO 没有变化，TTE 略有变化（分别为+2.6%和-1.2%）。所有四名参与者在移植后恢复期都出现了训练不足。移植后重新训练后，所有四名参与者的 TTE 均有所增加（4-24%），三人的 VO 增加（≥11%），两人的 PO 增加（≥7%）。
基于家庭的力量和条件计划可以有效并成功地纳入治疗性 SCI 试验。然而，这些计划的开发需要大量的内容知识和经验。
