Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury

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Abstract This application for an administrative supplement requests approval for a one-year extension with partial funding to enable the completion of this ongoing randomized trial that is currently in its fifth year of funding. The funded trial aims to test the hypothesis that a multi-modality intervention that includes hybrid exercise plus testosterone and targets deficits in multiple physiologic organ systems will be more efficacious in improving musculoskeletal and metabolic health and wellbeing of people living with SCI than hybrid excise plus placebo. This hypothesis is being tested in a randomized trial in 88 persons with C7 to T12 SCI, AIS grade A, B or C, 6 months or later after SCI. Participants are being randomized to either the multi-modality intervention or hybrid exercise plus placebo for 16 weeks, stratified by age, sex, and AIS grade. After 2-weeks of training in the exercise laboratory, the intervention is conducted in the participant’s home, using video monitoring of the home exercise. Primary outcome is peak aerobic capacity. Secondary outcomes include self-reported function and mobility assessed using computerized adaptive test version of Spinal Cord Injury-Functional Index; muscle mass and strength; fat mass and fat distribution; insulin sensitivity; lipids; inflammatory markers; and wellbeing (mood, anxiety, pain, and life satisfaction). The aims or the design of the funded trial have not changed. Very shortly after the trial's initiation, the sudden onset of the COVID pandemic led to nationwide shutdown of most non-covid clinical research activities. Due to the complete shutdown of clinical research for several months in 2022 followed by slow ramp up of clinical research activities in 2020 and 2021 due to multitude of factors that are discussed in the application, the enrollment in the trial suffered. In spite of these COVID-related challenges, the enrollment in the trial during the past year has increased substantially and the current enrollment rate exceeds that projected in the original grant application. Therefore, the parent as well as the supplemental bone study are on target for completion in the coming year. An additional year of partial support of the project would enable completion and close-out of the trial, accomplishment of all the proposed aims of the project, and accrual of full returns on the NIH's generous investment in this important project of high priority to people living with a SCI. Spinal cord injury (SCI) is one of the most grievous conditions that greatly impairs a person's mobility, function, overall health, and wellbeing, and increases healthcare resource utilization and costs and caregiver burden. The National Center for Medical Rehabilitation research has designated “pharmaceutical, stimulation, and exercise…strategies to improve motor function and health of SCI patients” a priority area of research. Because all components of the multimodality intervention are commercially available, the findings of this innovative trial upon its completion could be expeditiously translated into clinical practice and improve the health and wellbeing of people with SCI.