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

Jennifer Maher, Kim Anderson, Gant Katie, Rachel Cowan

Research output: Contribution to journalArticle

Abstract

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.
Original languageEnglish
JournalSpinal Cord
Early online date3 Jun 2020
DOIs
Publication statusE-pub ahead of print - 3 Jun 2020

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