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.
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 (VO2peak) (≥17%), peak power output (POpeak) (≥8%), and time to exhaustion (TTE) (≥7%). Deployment phase: pretransplant training minimally increased fitness in the two male participants (≥6% POpeak and ≥9% TTE). The two women had no POpeak 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 VO2peak (≥11%), and two increased POpeak (≥7%).
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.
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All data generated and analyzed in this study are available from the corresponding author on request.
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The authors would like to acknowledge the work of Kathleen Nagle.
This work was supported by The Miami Project to Cure Paralysis, Buoniconti Fund to Cure Paralysis, and the Bryon Riesch Paralysis Foundation.
Conflict of interest
The authors declare that they have no conflict of interest.
We certify that all applicable institutional and governmental regulations concerning the ethical use of human volunteers were followed during the course of this research.
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Maher, J.L., Anderson, K.D., Gant, K.L. et al. Development and deployment of an at-home strength and conditioning program to support a phase I trial in persons with chronic spinal cord injury. Spinal Cord (2020). https://doi.org/10.1038/s41393-020-0486-7