Jennifer L Maher1,2, Kimberly D Anderson3, Katie L Gant4, Rachel E Cowan4,5. 1. Department for Health, University of Bath, Bath, UK. jlm92@bath.ac.uk. 2. The Miami Project to Cure Paralysis, University of Miami, Miller School of Medicine, Miami, FL, USA. jlm92@bath.ac.uk. 3. Department of Physical Medicine and Rehabilitation, Case Western Reserve University, Metrohealth Medical Center, Cleveland, OH, USA. 4. The Miami Project to Cure Paralysis, University of Miami, Miller School of Medicine, Miami, FL, USA. 5. Department of Physical Medicine and Rehabilitation, University of Alabama Birmingham, Birmingham, AL, USA.
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 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. SETTING: University-based laboratory. METHODS: 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. 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 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%). 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.
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 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. SETTING: University-based laboratory. METHODS: 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. 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 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%). 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.
Authors: Mark S Nash; Suzanne L Groah; David R Gater; Trevor A Dyson-Hudson; Jesse A Lieberman; Jonathan Myers; Sunil Sabharwal; Allen J Taylor Journal: Top Spinal Cord Inj Rehabil Date: 2018
Authors: Katie L Gant; James D Guest; Anne E Palermo; Aditya Vedantam; George Jimsheleishvili; Mary Bartlett Bunge; Adriana E Brooks; Kim D Anderson; Christine K Thomas; Andrea J Santamaria; Monica A Perez; Rosie Curiel; Mark S Nash; Efrat Saraf-Lavi; Damien D Pearse; Eva Widerström-Noga; Aisha Khan; W Dalton Dietrich; Allan D Levi Journal: J Neurotrauma Date: 2021-05-03 Impact factor: 4.869