Development and deployment of an at-home strength and conditioning program to support a phase I trial in persons with chronic spinal cord injury

Study design Nonrandomized clinical trial (NCT02354625).Objectives As a part of a Phase I clinical trial to assess the safety of autologous human Schwann cells (ahSC) in personswith chronic spinal cord injury (SCI), participants engaged in a multimodal conditioning program pre- and post-ahSCtransplantation. The program included a home-based strength and endurance training program to prevent lack of fitness andposttransplantation detraining from confounding potential ahSC therapeutic effects. This paper describes development,deployment, outcomes, and challenges of the home-based training program.Setting University-based laboratory.Methods Development phase: two men with paraplegia completed an 8-week laboratory-based ‘test’ of the home-basedprogram. Deployment phase: the first four (two males, two females) participant cohort of the ahSC trial completed theprogram at home for 12 weeks pre and 20 weeks post ahSC transplant.Results 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 inthe two male participants (≥6% POpeak and ≥9% TTE). The two women had no POpeak changes and slight TTE changes (+2.6and −1.2%, respectively.) All four participants detrained during the posttransplant recovery period. After posttransplantretraining, all four participants increased TTE (4–24%), three increased VO2peak (≥11%), and two increased POpeak (≥7%).Conclusions Home-based strength and condition programs can be effective and successfully included in therapeutic SCItrials. However, development of these programs requires substantial content knowledge and experience.